Express Pharma (Vol. 20, No. 2) January 2025 by Indian Express

VOL. 20 NO. 2 PAGES 88

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REPORT

KPMG 2024 Life Sciences CEO Outlook

INDIA'S FOREMOST PHARMA & BIOTECH MAGAZINE SINCE 1994

JANUARY 2025, ` 40

CONTENTS

Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

Pg20

Editorial Team Lakshmipriya Nair Kalyani Sharma Kavita Jani Neha Aathavale DESIGN Art Director Pravin Temble Senior Designer

REPORT

BIOPHARMA

Rekha Bisht

Senior Artist Rakesh Sharma

WILL EPYGEN’S BIOSIMILARS BETS PAY OFF?

INTERVIEW

KPMG 2024 LIFE SCIENCES CEO OUTLOOK

Marketing Team Rajesh Bhatkal Ashish Rampure Debnarayan Dutta

WE AIM TO STRENGTHEN OUR PRESENCE IN ASIAN AND MENA REGIONS, WITH PARTICULAR EMPHASIS ON INDIA

CILICANT IS CHANGING THE WAY WE THINK ABOUT ACTIVE PACKAGING

COVER STORY

Production Co-ordinator

Dhananjay Nidre Scheduling & Coordination Pushkar Waralikar CIRCULATION

INNOVATION, PARTNERSHIPS AND BEST PRACTICES: PRIORITIES FOR BIOPHARMA IN 2025

SUSTAINING EXCELLENCE: THE EVOLVING ROLE OF QUALITY IN PHARMA

NUTRACEUTICAL S 2025: MAPPING GROWTH, INNOVATION, AND CONSUMERCENTRIC TRENDS

GROWTH MANTRAS FOR INDIA PHARMA IN 2025: INNOVATION, PARTNERSHIPS, SUSTAINABILITY

TRENDS 2025: REDEFINING THE PHARMA SUPPLY CHAIN

Mohan Varadkar

Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2025 - 27. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Mafatlal Centre, 7th floor, Ramnath Goenka Marg, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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EDITOR’S NOTE

2025: A year of stricter rules, course corrections?

ill 2025 see a more vigilant government when it comes to violations by pharma companies, be it GMP slip ups or the Uniform Code of Pharmaceutical Manufacturing Practices (UCPMP)? For instance, time is running out for MSME pharma companies, as we pass the December 31 deadline to comply with the revised Schedule M of the Drugs and Cosmetics Act. While this segment of pharma companies, a turnover of less than Rs. 250 crore, was given an extra six months to comply with these revised rules, industry insiders comment that even most larger companies, have not yet fully complied with all requirements of the revised guidelines. Multiple industry associations representing MSME pharma have approached the authorities to extend the deadline for them to complete upgrading their facilities but so far there has been no response. The word is that the government will have no choice but to extend the deadline to avoid the shuttering of non-compliant factories which might lead to shortages. The ensuing job losses and dip in state revenues will also play a role in this decision. Sources also indicate that the regulatory authority government too needs more time as there are many drug inspector posts still vacant. This clearly means that even if there is no extension of the December 31 deadline, it would be some time before inspections can be rolled out. This lacuna was highlighted during the ongoing parliamentary session, when the fifth report of the Parliamentary Standing Committee on Chemicals and Fertilisers presented to the Lok Sabha during this session, mentioned that as of last December, almost 60 per cent of the sanctioned strength of drug inspectors, which is 303 out of the total 504 posts, were vacant. The Committee has urged the centre to fill up these vacancies on priority as well as assess the need to sanction more posts, considering that the country has more than 750 districts.The fifth report cited the need "to ensure effective regulation and oversight owing to the multifaceted issues grappling the spurious/NSQ drugs", noting that “as on date only 5.9 per cent (only 35 convictions) of the total 593 cases relating to spurious/adulterated drugs have been resolved, with the remaining cases at various stages in respective courts." While there have been reports of plans to recruit 250 drug inspectors, the health ministry clearly needs more time. Secondly, consider the Department of Pharmaceuticals' action on an anonymous complaint that AbbVie Healthcare India had violated the Uniform Code of Pharmaceutical Manufacturing Practices (UCPMP). According to the December 23, 2024 order of the Apex Committee for Pharma Marketing Practices of the

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Will 2025 see a more vigilant government when it comes to violations by pharma companies, be it GMP slip ups or the Uniform Code of Pharmaceutical Manufacturing Practices (UCPMP)?

Ministry of Chemicals & Fertilizers Department of Pharmaceuticals, the complaint provided proof that the company 'provided travel tickets and hotel accommodations for extravagant pleasure trips under the guise of conferences' (Aesthetics & Anti-Aging Medicine World Congress 2024), which took place from February 1 to 3, 2024, and from March 26 to 29, 2024, in Monaco and Paris, respectively, for 30 doctors connected to the medical aesthetics/ anti-ageing products (Botox and Juvederm). After audits and hearings, the DoP has asked for the reprimand to be posted on the pharma company's website and will be evaluating the tax liability of AbbVie Healthcare India along with 30 HCPs and take action in accordance with the provisions of the Income Tax Act, 1961. Thirdly, the Apex Commitee has requested the National Medical Council (NMC) to take action against the 30 offending HCPs as per Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. The government's tough stance on UCPMP, possible GMP inspections and the upcoming Union Budget will see pharma companies hoping to influence DoP officials. For example, industry lobby groups reportedly met government officials to give their suggestions on guidelines for over the counter (OTC) medicines. The government is reportedly mulling a list of medicines which can safely make the switch from prescription (Rx) to OTC. Though these medicines are already freely available without prescriptions in most pharmacies, the official Rx to OTC switch will allow them to be sold in groceries stores as well. Online pharmacies too will benefit from more Rx medicines the switching to OTC. While the Rx to OTC switch will improve access, there is already rampant use of many such medicines. The lack of awareness on the potential overuse and misuse of OTC medicines, thanks to low literacy levels and multiple languages in India, is a serious concern. Can government officials ensure that while making the Rx to OTC switch, there are adequate awareness campaigns, highlighting the proper use of such medicines to prevent misuse? Will the ruling in the AbbVie Healthcare India case prevent future violations of the UCPMP? Is the government looking to set a similar example on the implementation of the revised Schedule M and updated GMP standards? Will this stance slowly restore public trust in pharma companies, as well as the DoP which has been accused of being more industry friendly than patient-centric? 2025 could thus be a pivotal year for course corrections for all stakeholders.

VIVEKA ROYCHOWDHURY, Editor viveka.r@expressindia.com viveka.roy3@gmail.com

BIOPHARMA

Will Epygen’s biosimilars bets pay off? Debayan Ghosh, founder, Epygen Group, has ambitious plans to snag a slice of the booming $70 billion global biosimilar pie. In a conversation with Viveka Roychowdhury, he analyses the journey so far, spanning pandemic preparedness projects like protein-based vaccines, building up pipeline revenue streams in diabetes, oncology, immunology and cardiovascular biosimilars, and his strategies to scale up and expand to other therapeutics like anti-obesity drugs

ne of the trends set to define 2025, and the decade ahead, is the 2022-30 patent cliff, and the gradual shift in biopharma revenues from small to large molecules. While India was able to leverage the 2008 patent cliff of small molecules, the same playbook will not work for biologics and biosimilars. Of the top 24 blockbuster drugs going off-patent during the patent cliff 2022-2030, 14 are biologics, as per a study conducted in August 2023 by the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers, Govt of India. The study also points out that sales of biologics like biosimilars, immunomodulators and monoclonal antibodies, which comprised 69 per cent of overall revenues of these 24 blockbuster drugs in 2022 will increase to 75 per cent by 2030. Many biopharma companies in India have already leveraged the biosimilar patent cliff. For instance, the DoP study points out that while blockbuster biologic Humira (adalimumab) lost exclusivity in the US in early 2023, the Indian government permitted multiple companies to manufacture adalimumab under the provisions of compulsory licensing from 2018. Biocon became the first company from India to launch its biosimilar Hulio in the US in July 2023. While Biocon and peers are in the limelight, this decade will hopefully mark the coming of age of quite a few ‘baby Biocons’: smaller biotech companies, following in the footsteps of the pioneers. One of these aspiring companies is the Dubiotech Park-headquartered Epygen Group, headed by

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Debayan handled the enzymes business at Biocon in the late 1990s. He was very driven and when we pivoted to biopharma he ventured out and eventually set up Epygen Biotech. He has been in touch with me over the years apprising me of his progress. He is very entrepreneurial and the fact that he has endured the challenges of building his business, does speak volumes of his commitment to succeed. I am extremely proud to see many new ventures set up by our enterprising former employees and Epygen is one of them. I wish Debayan greater success Kiran Mazumdar-Shaw Chairperson, Biocon

Now that Epygen has proven itself to be capable to handle a wide range of microbial expression hosts and corresponding biosimilars purification and formulations as a CDMO at a certain scale with a steady revenue stream, we are ready to replicate/scale up and would be tapping investors in the near future. The success model in this space is well understood by us Debayan Ghosh Founder & CMD, Epygen Group

founder Debayan Ghosh. Not surprisingly, he cut his biotechnology teeth in … where else? Biocon.

A seed is sown After a BTech from University

of Calcutta, Ghosh was part of one of India’s earliest batches of MTechs in biotechnology from Anna University, Chennai’s Center For Biotechnology. In 1993, Ghosh, like most aspiring biotechnologists, made his

way to Biocon. Set up in 1978, Biocon was slowly and silently laying the foundation of India’s biotechnology sector. As a fresher recruit from campus, Ghosh found himself working along-

side technologists from renowned institutes like MIT Boston, who had heeded founder Kiran MazumdarShaw’s call, to come back to India and put India on the global biotech map. Looking back on those early days, Ghosh believes that Biocon has been “like an incubator for biotech entrepreneurs”, recalling that in the early 1990s, very few people knew about biotechnology or Biocon. “We used to throw a party every time you got a big order … that was how we started, filled with the thrill of adventurism.” Ghosh is referring to a certain brand of bio-entrepreneurship, following the footsteps of Biocon founder Mazumdar-Shaw. He spent almost five crucial years early in his career, developing enzyme technologies and learning the industrial biotech and enzyme business from some of the best scientists/ biotechnologists in the world. Commenting on Ghosh, Mazumdar-Shaw, Chairperson, Biocon recalls that he handled the enzymes business at Biocon in the late 1990s. “He was very driven and when we pivoted to biopharma he ventured out and eventually set up Epygen Biotech.” Commending him on his success, Mazumdar-Shaw comments that Ghosh has been in touch over the years apprising her of his progress. “He is very entrepreneurial and the fact that he has endured the challenges of building his business, does speak volumes of his commitment to succeed.” In fact, Mazumdar-Shaw and Biocon have been the guiding light for many ventures in the biotech field and beyond. Alluding to this fact, Shaw-

BIOPHARMA Mazumdar wishes greater success to Ghosh, commenting that she is extremely proud to see many new ventures set up by enterprising former Bioconites.

The biosimilar CDMO opportunity Mazumdar-Shaw’s wishes for Ghosh’s greater success speaks volumes, given the intense competition in the biologics market. As per a Frost & Sullivan analysis, the share of the global biologics market in the global drug market rose to nearly one-fourth in 2022 and is expected to reach 31.8 per cent by 2026 and 37.5 per cent by 2030. Pharma companies choose to outsource development and manufacturing of biologics as scale dictates profitability. Thus as per the Frost & Sullivan analysis, the global market size of biologics contract development and manufacturing organisations (CDMOs) has grown significantly from $13.3 billion in 2018 to $29.3 billion in 2022 and is projected to reach $58.1 billion by 2026 and $100.4 billion by 2030. The good news is that as many biologics near patent expiries, the biosimilars CDMO market is moving to geographies like Asia where production costs can be scaled down by improving R&D efficiency and clinical performance. Ghosh’s personal estimate is that the CDMO market could be up to $30 billion, outsourced primarily by the US and some Western European countries. In the long term, he believes that the US BioSecure Act could leverage India over competitor China owing to the Wuhan incident. While President elect Trump’s goal as part of the Make America Great Again movement would be to ship higher value-addition activities to the US, the cloning work, scaling up and toxicology clinical batches could be outsourced, significantly impacting Novel Biological Entity (NBE) economics. Considering that the development cost of a biologics is close to half a billion to a billion dollars, Ghosh believes “that is where we see a lot of potential

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The Epygen team has been able to successfully utilise its several years of ‘end to end’ biosimilars experience starting from cloning till vialing of molecules establishing titers and yield levels as per mandate. The state of the art cGMP facility has national and international accreditations Dr Girish Walavalkar CEO, Epygen Biotech

for India in terms of pitching in as a biologics CDMO hub.” While India’s biologic CDMO market is currently worth “just a couple of hundred crores”, Ghosh is certain “it's going to double in three-four years and is predicted to grow five times over the next decade”. Typically, biologics development companies are expected to maximise hit rates by simply outsourcing standardised processes.

The business pitch While the seeds of entrepreneurship were sown at Biocon, it was Ghosh’s next stint at Florida-based Dyadic International that gave him the business idea. He spent the next six years working with a fine team of scientists at Dyadic USA who focused on a unique expression host system that would catapult productivity levels of critical biologics, with a clear goal to make those drugs affordable to the masses. Explaining the challenges of biomanufacturing in lay man’s terms, Ghosh says, “You just could not make or passage as much as you commercially desire because nature calls the shots and says, hey, you cannot make the bacteria or fungi metabolise more than a certain level, because I have programmed this organism to make only so much protein. So that's when recombinant platform technologies came into play.” Ghosh narrates how biologics companies “efficiently tweaked genes, shot up expressions while adapting proteins to fit the human model.” Licensing out such expression platforms to big pharma companies had proven extremely profitable. Having aced both the science and the business of licensing out technologies, he decided to bring these learnings closer to home. Once again, he harks back to his early days in Biocon where the zeal to harness scientific progress for the benefit of the Indian people attracted talents back to India. While shortlisting possibilities to expand back in India, he was approached by the UAE government, which was looking

BIOPHARMA to start the Dubiotech Park, Dubai. Impressed by the scale and speed of investments, Ghosh found a middle path. In 2006, he started Epygen Labs, with its headquarters based in Dubiotech Park, Dubai, UAE, focusing on industrial biotechnology. After five years, revenues were steady enough for “the final frontier’ as Ghosh puts it: to take the plunge into biopharma manufacturing. Epygen Biotech India was started in 2011, and today comprises an end to end biopharma R&D and manufacturing facility at MIDC Patalganga, near Mumbai, which develops and produces critical therapeutic proteins for both biosimilars and NBE space. More than a decade later, and having more than Rs 120 crores invested in Epygen’s Patalganga manufacturing facility, Epygen is living by its tag line “building future strand by strand”, as a biotech CDMO involved in developing and manufacturing affordable biologics for patients in the region and beyond. Today, as founder of the Epygen Group, Ghosh leverages his contacts and expertise across three continents, hoping to snag a slice of the $70 billion global biosimilar pie, tapping biosimilars in the diabetes, oncology and cardiovascular segments.

Key milestones After inception, Epygen Biotech licensed in a biosimilar recombinant Streptokinase (rSK) from Institute of Microbial Technology (IMTECH) which was designed to solubilise clots causing myocardial infarction (ST Elevation Myocardial Infarction: STEMI) with a goal to replace the beta lactam marker with a non-beta lactam from its gene for improved patient safety profile. Subsequently licensing process and development was initiated for a further modified version of rSK for ischemic stroke and STEMI. Tipped to ‘revolutionise the way ischemic strokes are treated around the globe’ as per the Epygen Biotech press note, this NBE could be administered to ischemic stroke

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patients within a much wider window of 8-10 hours, unlike existing stroke medication, which has only a three-hour window. This prolonged window of administration was aimed to drastically improve patients’ survival. Additionally Epygen would make the NBE

at a fraction of the cost, while ensuring no side effects unlike other drugs used for Ischemic stroke that compromised blood brain barrier. Ischemic stroke, commonly referred to as brain stroke, is caused by the blockage of an artery that supplies oxygen to

the brain. It is reportedly a leading cause of death and disability in CVD patients and an estimated 15-17 lakh Indians suffer from it every year. Globally, as per the American Stroke Association (ASA), brain strokes are the second leading cause of death in the

world with a staggering 15 million people affected causing 11 million people to either die or become permanently disabled. The prevalence of stroke is much higher in India than the west and about 87 per cent of all the strokes are ischemic strokes.

BIOPHARMA The Epygen team made remarkable progress on improving yields and tweaking the gene to replace with a non-allergenic version, making it safer for the patients of thrombolysis, but by the time the team was ready to initiate human trials, COVID struck and clinical trials ground to a halt. While the company was able to pivot to answer the COVID challenge, Ghosh remains confident that their work on making the recombinant streptokinase NBE at an affordable cost for cardiovascular use will proceed in the future. The burden of stroke remains a global concern and an affordable recombinant streptokinase would be the logical solution. Especially as

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Pharma companies choose to outsource development and manufacturing of biologics as scale dictates profitability.As per a Frost & Sullivan analysis, the global market size of biologics CDMOs has grown significantly from $13.3 billion in 2018 to $29.3 billion in 2022 and is projected to reach $58.1 billion by 2026 and $100.4 billion by 2030 more governments are set to negotiate medication prices and strive to control healthcare costs.

Prepping for the next pandemic With the rSK on the back

burner, Epygen needed to find a way to utilise their topline biomanufacturing facility and a team with proven skills in protein expression and purification rising to the cause of COVID. Ghosh tied up with his partners Dyadic International in the

US, who in turn were working with the European Union Zoonotic Anticipation and Preparedness Initiative (ZAPI) programme. This company developed and demonstrated the use of a highly productive proprietary protein production

platform, a key part of developing Receptor Binding Domain (RBD) based vaccines against present and future SARSCoV–2 variants. Through this tie up, in April 2022, Epygen Biotech received funding from the Department of Biotechnology, Government of India to initiate the Phase I and Phase II trials of an indigenous affordable RBD based vaccine against present and future SARS-CoV–2 variants. An example of the possible impact of Epygen’s work was that its involvement in the project was anticipated to reduce the price point to less than Rs 150 per dose, making it the first Indian protein vaccine able to adapt to the rapidly mutating variants of the virus (e.g.

BIOPHARMA Omicron BA.5). Looking at the big picture, Ghosh stresses that working on this project has “honed our skills in expressing proteins of interest very quickly using this expression platform” so that once CDC has the gene sequence of a variant of concern has been identified, the Epygen team can roll out a proteinbased vaccine in 100 days. These skills position Epygen as a key part of future pandemic preparedness platforms and strategies.

A clone to vial CDMO Beyond pandemic threats, Epygen’s biomanufacturing and development skills have progressed to offer the full suite of “clone to vial” activities, handling the complexities of optimising high cell density fermentation, protein purification, and scale up for a range of clients. Seated in his Patalganga facility, Ghosh explains how the company can handle varying client requests, with multiple CDMO suites where they can go from the client’s protein of interest to manufacturing the finished product for animal and then human trials in a few months time, depending on the project. Ghosh believes that Epygen is thus poised to tap the biologics CDMO market, which by all accounts, is the next growth frontier. “We do a few million vials of recombinant human insulin, which gives us 80 per cent or so of our CMO revenues”. Epygen’s current CDMO work focuses on insulin analogues, human hormones and obesity drugs. Ghosh indicates that while the current break up of revenues between CMO and CDMO is skewed towards the former, the aim is to slowly shift the current bias from M to D (from manufacturing to development).

Betting on the future While biosimilar CDMOs like Epygen are revving up to ride the wave of key biologics going off patent in coming years, a lot depends on timing and funding. Ghosh is gearing up to approach investors for the funding to scale up. As Ghosh

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reasons, “Now that Epygen has proved itself as a CDMO at a certain scale with a steady revenue stream, we are ready to replicate/scale up and would be tapping investors in the near future.” He strongly believes that 2025 will be about biotech

CDMOs charting funding strategies to scale up. Ghosh is betting on Big Pharma’s need to replace molecules losing exclusivity over the next decade and choosing to partner and invest in relatively mid-sized biotech companies like Epygen with key strengths, rather than setting

up individual biologics suites within their own manufacturing setup. Will the bet pay off? Quite a few smaller biotech companies are aiming for the same pot of gold but Ghosh seems confident of pulling it off as he feels this opportunity is here to stay for

the next decades in healthcare, and there is enough room for many. Will his pitch to find a funding partner succeed in time to catch the biosimilar CDMO wave? Only time will tell. viveka.r@expressindia.com viveka.roy3@gmail.com

cover )

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cover ) Innovation,partnerships and best practices: Priorities for biopharma in 2025 Industry experts highlight the progress made by the Indian biopharma sector, and suggest pathways to promote growth

Innovation must remain at the core of our efforts

ndia’s biopharma sector, currently valued at over $54 billion, is on a promising trajectory, and projected to reach nearly $63 billion by 2025. To emerge as global leaders, Indian biopharma companies must adopt a multifaceted strategy focused on innovation, scalability, and sustainability. First and foremost, innovation must remain at the core of our efforts. Investing in cutting-edge research, particularly in biosimilars, novel biologics, and cell and gene therapies, will be crucial. Collaborations with academia, start-ups, and global research organisations can help catalyse breakthroughs in precision medicine and advanced therapies. Secondly, scalability is crucial. With India having the highest number of US FDAcompliant drug manufacturing facilities outside the US, targeted capital investment in infrastructure will strengthen manufacturing and supply chains to enable the delivery of high-quality, affordable therapies at scale. Integrating advanced technologies such as AI and automation can further enhance operational efficiency, accelerate drug development timelines, and drive cost-effectiveness. Equally important is sustainability. Embracing green manufacturing practices and embedding environmental,

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Indian players need to focus on increasing their R&D investments and partner with leading universities

Kiran Mazumdar-Shaw, Chairperson, Biocon and Biocon Biologics

social, and governance (ESG) principles into operations will not only future-proof our businesses but also align with the global emphasis on sustainable healthcare solutions. Finally, an unwavering focus on talent development is non-negotiable. By nurturing a skilled workforce through specialised training programs

and fostering a culture of innovation, Indian biopharma companies can stay ahead of the curve in a highly competitive global market. In meeting the growing demand for transformative healthcare solutions and addressing pressing challenges, India’s biopharma sector can solidify its position as a global leader.

ndia has established itself as a significant player in the low-cost vaccines supply globally in the biopharma sector. Serum Institute of India (SII) is the world’s largest vaccine manufacturer. India is the largest vaccine producer in the world and accounts for 60 per cent of the global vaccine production. However, there are very few biopharma players who have made a mark globally with respect to biosimilars. Biocon has established itself as a leading biopharma player from India with a significant presence in biosimilars globally. On the biologics and personalised medicines research front, Indian players are still in a nascent stage and would need a lot of focus to make a stride in this area. To make a foothold in this area, Indian players need to focus on increasing their R&D investments and partner with leading universities and companies globally to support their research on biologics and personalised medicines. Indian players are still in the early stage of growth within the biosimilars seg-

Prashant Khadayate, Director- Lifesciences Consulting & Research, GlobalData

ment. For growth momentum, they need to invest substantially in improving their production capacity for biosimilars. Also, Indian players need to focus on leading markets like the US and Europe for commercialisation. However, there will be very few Indian players who will leave a mark in this segment in the long run, as it is a capital-intensive business with the involvement of high risks.

Localising key input materials, processes and equipment will drive both innovation and cost efficiencies

mmuneel Therapeutics is redefining cancer care in India by combining global expertise with local innovation. Through initiatives such as our partnership with the prestigious Hospital Clínic de Barcelona in Spain for the development and launch of Qartemi—our pioneering CD19 CAR T therapy for the treatment of adult patients with relapsed/refractory B-NHL—we are setting new standards in advanced treatments. Our innovation pipeline further underscores our dedication to addressing unmet medical needs, while collaborations with major hospitals in India ensure

Amit Mookim, Chief Executive Officer, Immuneel Theraputics

that patients have access to world-class therapies. As we look to 2025, we remain steadfast in our mission to democratise cutting-edge care, bringing

hope and healing to patients across the region. To emerge as leaders in the biopharma field, Indian companies must focus on several key

strategies. First, fostering strategic partnerships with global institutions is critical to gaining access to the latest technologies and best practices. Second, investing heavily in research and development will be essential to staying ahead of the competition and addressing the evolving needs of patients, particularly in advanced areas like cell and gene therapies. Third, collaborating with regulators to create robust regulatory pathways that support innovation, while maintaining high safety and efficacy standards, is also vital. Additionally, localising key input materials, processes and equipment will drive both inno-

vation and cost efficiencies, making advanced therapies more accessible and sustainable in the region. Companies must prioritise improving patient access to life-saving treatments by partnering with major hospitals to build a sustainable healthcare ecosystem. Finally, cultivating a culture of innovation, agility, and collaboration will empower Indian biopharma players to drive the future of healthcare—not only in India but on the global stage. At Immuneel, we are committed to these strategies, positioning ourselves at the forefront of this exciting evolution in medicine.

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cover ) QUALITY

Sustaining excellence: The evolving role of quality in pharma In the ever-evolving landscape of the pharma industry, the pursuit of quality remains a cornerstone of success. As stringent regulatory frameworks, rising patient expectations, and the increasing pace of innovation, transforms the pharma industry, the definition of quality is also evolving. From ensuring compliance with global standards to embracing cutting-edge technologies like AI-driven quality control, the industry is navigating a paradigm shift in how it approaches product integrity, safety, and efficacy. In this New Year issue, pharma experts explore how crucial it is to foster a culture of quality across organisations and deliver better healthcare outcomes

Quality leaders will need to foster a culture of continuous learning

uality management in pharmaceutical industry is critical to ensuring the safety, efficacy, and consistency of drugs. However, there are several challenges that pharma companies face in maintaining high-quality standards. Regulatory compliance and evolving standards: Regulations imposed by authorities such as the FDA, EMA, and other national regulatory bodies are frequently updated, requiring constant monitoring and adaptation. Ensuring that all products meet required standards at every stage— from development to postmarket surveillance can be time-consuming and costly. Non-compliance can result in severe penalties, recalls, and damage to a company’s reputation. Important is patient centricity during development, manufacturing and quality monitoring. Data integrity and documentation: Need for accurate and reliable data is paramount. Regulatory bodies require strict documentation and data tracking without any discrepancies. With increasing use of digital technologies

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Dr Ranjit Barshikar, CEO-QBD International, United Nations Advisor

and automation, ensuring integrity and traceability of data becomes more complex. Poor data management can lead to regulatory fines, delays in approval processes, and compromised product quality. Supply chain complexity: Supply chain is intricate, involving multiple suppliers,

manufacturers, and distribution channels. Variability in raw material quality, supply chain disruptions and counterfeit drugs are persistent concerns. Any interruption or failure in the supply chain can affect quality of final product, leading to shortages or quality issues.

Risk management and quality assurance: Identifying, assessing, and mitigating risks related to product quality, safety, and efficacy is a complex task. The use of ICH Q9 guideline is crucial, but integration of risk management practices across every stage of production and development (from R&D to manufacturing and distribution) can be challenging. Inadequate risk management practices may lead to recalls, adverse events, and product failures. Technology integration and automation: Pharma industry is increasingly turning to automation, AI/ML to improve production efficiency, reduce human error, and enhance quality. However, implementing and maintaining these technologies in a highly regulated environment can be difficult. Ensuring that automated systems comply with gmp and human oversight remains robust is essential. Poor integration or malfunction of these technologies can result in quality lapses, regulatory violations, or inefficiencies. Addressing these challenges requires constant vigilance, investment in technol-

ogy and training, and a proactive approach to regulatory changes and quality control processes.

Role of a quality leader It is evolving significantly as industry increasingly embraces digital health solutions and precision medicine. These developments introduce new complexities in ensuring product safety, efficacy, and regulatory compliance, requiring a more dynamic, technologydriven approach to quality management. Integrating digital health technologies into quality systems: Quality leader must have a comprehensive understanding of digital health technologies and how they interface with global regulatory frameworks. They also need to ensure that data generated through these platforms are accurate, reliable, and meet the required standards for clinical trials or post-market surveillance. Ensuring compliance with data privacy and cybersecurity standards: Quality leaders must not only be aware of regulatory compliance for drug manufacturing

but also for the security and privacy of patient data. They will need to ensure that appropriate cybersecurity protocols are in place, and the systems for storing and handling data are validated and protected against vulnerabilities. Facilitating real-time monitoring, data analytics: The quality leader must enable the real-time tracking and analysis of data, ensuring that the systems are validated and that any data used for decisionmaking meets the highest standards of accuracy and reliability. This requires expertise in data analytics, artificial intelligence, and machine learning, as

plines and stakeholders: The quality leader must take on a more collaborative role, engaging with cross-functional teams in R&D, regulatory affairs, it, and clinical operations to ensure quality across the product lifecycle. They may need to act as a bridge between technical and non-technical teams, ensuring that quality principles are upheld across the entire process—from initial development through to patient outcomes. Continuous training and development: Quality leaders will need to foster a culture of continuous learning, where team members are trained in

The role of a quality leader is evolving from a traditional, compliance-focused position to one that is more dynamic, strategic, and technology-driven well as collaboration with it and digital health teams. Managing complexity of personalised/precision medicine: Quality leaders must ensure that manufacturing processes can accommodate the personalised nature of precision medicine. This includes overseeing the validation of personalised treatments, ensuring consistency in production despite variations in patient profiles, and managing regulatory requirements for products that are individualised or used in smaller populations. Adopting agile quality management practices: The quality leader will need to embrace agile quality management practices, such as iterative testing, continuous improvement, and flexible documentation practices, to accommodate the fast pace of digital and personalised medicine innovation. This requires a shift from a "one-size-fitsall" approach to a more adaptable, risk-based model of quality assurance. Collaborating across disci-

emerging technologies, data management, and the unique challenges of digital health and precision medicine. This includes keeping abreast of regulatory changes, new tools, and new technologies that could impact quality management processes.

In times to come As digital health solutions and precision medicine reshape the pharma landscape, the role of the quality leader is evolving from a traditional, compliance-focused position to one that is more dynamic, strategic, and technologydriven. Quality leaders will need to be not only experts in regulatory standards and quality systems but also adept in managing the complexities of new technologies, data privacy issues, and personalised treatment modalities. Their ability to integrate digital innovations while ensuring patient safety, compliance, and product consistency will be critical to the success of pharma companies in this new era.

The complex nature of pharma necessitates effective collaboration

repping to meet the biggest challenges in the pharma sector requires a multi-pronged approach like: Skill shortages and training needs: The rapid evolution of technology and scientific advancements necessitates ongoing training and upskilling of the workforce. However, identifying skill gaps and providing relevant training programmes pose significant challenges for pharma leaders. Implementing tailored training initiatives and partnering with academic based institutions and training providers can help address these challenges effectively. Cross-functional collaboration: The complex nature of pharma necessitates effective collaboration across diverse functional areas, including R&D, regulatory affairs, marketing, and manufacturing. However, communication barriers, and conflicting priorities can hinder collaboration efforts. In addition to supporting a collaborative culture, it can also be useful to focus on communication skills to facilitate collaboration. Work-life balance and employee well-being: The demanding nature of work in the pharma industry, coupled with tight deadlines and regulatory pressures, can take a toll on employee well-being and work-life balance. Leaders must prioritise employee health and well-being and promote work-life balance initiatives. Succession planning: Succession planning is critical for ensuring continuity and sustainability in leadership roles, particularly in the pharma industry, where leadership turnover can disrupt operations and impede innovation. Leaders must proactively identify and develop high-potential employees, create personalised development plans, and groom future leaders to fill key roles within the organisation.

Dr BM Rao, CEO, QDOT Associates, Hyderabad

Quality leader must have a comprehensive understanding of digital health technologies Evolving role of a quality leader Managing change: Leaders must be able to anticipate and mitigate challenges that may arise when adopting new technologies. This can include: ◆ Building a case for change ◆ Communicating goals and vision clearly ◆ Providing support to team members ◆ Establishing a governance structure ◆ Establishing training

Leading teams: Leaders must be able to build and manage teams with the skills and expertise needed to implement and support digital health solutions Being a decision-maker: Leaders select technologies to be implemented Advocating: Leaders advocate for patients, personnel, and digital health Sharing information: Leaders share information in an organisation

EXPRESS PHARMA

January 2025

cover ) BIOPHARMA

Nutraceuticals 2025: Mapping growth, innovation,and consumer-centric trends Industry experts highlight the evolving dynamics, regulatory needs, and personalised solutions driving the nutra market ahead of 2025

The Indian nutraceutical market is set to grow sixfold by 2030

he Indian nutraceutical market is projected to reach $64 billion by 2030. Currently, it stands at around $5-10 billion, which means it is expected to grow approximately sixfold at an annual growth rate of 14 per cent. The trend is definitely upward, and post-pandemic awareness about nutraceuticals has accelerated this growth. People are increasingly leaning towards prevention and preventive care rather than relying solely on therapeutic medications. The nutraceutical market began to gain traction around 2005-2010, growing steadily since then. However, the COVID-19 pandemic served as a significant turning point, increasing awareness about health and wellness. People started understanding the importance of maintaining their health proactively. The nutraceutical market is typically divided into three segments: 1. General health awareness: This segment caters to individuals who are health-conscious but not necessarily athletes or fitness enthusiasts. Products in this segment include multivitamins, omega supplements, and other general wellness products that address common health needs. 2. Sports nutrition: This category is designed for athletes or individuals engaged in high-intensity physical activities like powerlifting or muscle building.

26 EXPRESS PHARMA January 2025

Kalka Prasad, AVP - Marketing, Crius Life

India is already considered pharmaceutical hub, and regulatory clarity can further boost the nutraceutical industry

Such individuals require specific nutrition, such as higher protein intake, omega supplements, and antioxidants, to support their rigorous routines. 3. Medical nutrition: This is a growing segment addressing specific medical needs. Products in this category are often prescribed by practitioners, such as nephrologists for renal care or diabetologists for managing diabetes. Medical nutrition includes formulations for conditions like cardiac health, diabetes, and renal issues, often recommended as supplements to complement a patient’s diet when regular meals alone cannot meet all nutritional requirements. India is already considered a pharmaceutical hub, and regulatory clarity can further boost the nutraceutical industry. Recently, FSSAI introduced amendments to ensure a clear separation between drug and nutraceutical production facilities. This prevents issues like cross-contamination. For instance, vitamin D supplements produced in doses under 600 IU are categorised as food, while higher doses are classified as drugs. However, this demarcation often leads to ambiguity, as the core nature of the ingredient remains unchanged. Similarly, methylcobalamin (Vitamin B12) highlights regulatory inconsistencies. For general use, the recommended dose is 2.2 mcg, but for medical purposes, doses can go up to

1,500 mcg or more. Despite its nutraceutical nature, certain manufacturing restrictions exist, creating confusion. Greater awareness and transparency from regulatory bodies would help manufacturers and consumers alike. To ensure the industry’s growth, several factors need attention: 1. Awareness: Government initiatives should focus on educating people about the role of nutraceuticals in day-to-day wellness and preventative health care. 2. Quality Standards: Uniform regulations and compliance with standards like WHO CGMP are critical. Currently, many players in the market do not adhere to these standards, resulting in inconsistent quality. Regulatory enforcement should be stricter and uniform for all players. 3. Research and Development: R&D is the backbone of innovation. Companies should allocate 10-15 per cent of their budgets to R&D to develop new and innovative products. My company, for instance, has been recognised as an innovative company and is continuously investing in R&D to maintain its edge in the market. In conclusion, while the industry is poised for significant growth, addressing regulatory ambiguities, enhancing quality standards, and fostering innovation will be critical for sustained progress.

The future of nutraceuticals lies in personalised, impactful, and sustainable solutions backed by science

s we step into 2025, the nutraceutical industry is going through a transformative phase driven by dynamic consumer demands, technological advancements and a growing demand for customisation. Today’s consumers are more aware and proactive about their health and fitness levels and are seeking products that are not only effective but also to a large extent, tailored to their unique

needs. Trends like personalised nutrition, fueled by advancements in genomics and AI, are redefining how we approach health and wellness. Focus on strong R&D and product innovation with science-backed solutions will be rampant in the coming year. At Nutrabay, we focus heavily on product R&D and innovation and deploy sizable resources on identifying new ingredients and formulations

that are efficacious. Along with product innovation, transparency about ingredient usage and consumer education to impact ingredients or combination of ingredients on their systems empower consumers to take control of their wellbeing and support their unique health goals. As we look ahead, the future of nutraceuticals is one of personalised, impactful, and sustainable solutions that truly enhance lives.

Shreyans Jain, Founder & Executive Director, Nutrabay

EXPRESS PHARMA

January 2025

cover ) The rise of personalised vitamin supplements marks a new era in tailored health and wellness solutions

he global nutraceuticals market size was valued at $712.97 billion in 2023 and is expected to grow at a CAGR of 8.4 per cent from 2024 to 2030. Whereas the global vitamin supplements market size was estimated at $48.51 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7.3 per cent from 2023 to 2030. Vitamins and supplements are the products taken in small doses concentrated to support the body's physiological functions, maintain health status,

28 EXPRESS PHARMA January 2025

promote physical and mental well-being or reduce the risk of disease. A significant trend in the dietary supplement market is the rise of personalised vitamin supplements, tailored to an individual's specific health needs, lifestyle etc. This approach involves using health assessments, blood tests in order to determine the exact vitamins and minerals an individual requires. For example, some people might need higher doses of vitamin D due to low sun expo-

sure and age-related deficiencies, while others may require more vitamin B12 because of an imbalanced diet. Keeping in view of this, companies like GSK, Herbalife, Pfizer etc are offering in the forms like pills, powders, or even liquid sachets for vitamin supplements. Health experts caution that while personalised supplements are promising, they should complement a wellrounded diet and be taken under medical supervision to ensure safety and efficacy.

Dr G Chakravarthi, Principal, College of Pharmacy, KL Deemed to be University

TRENDS IN 2025

Growth mantras for 2025: Innovation, Partnerships,Sustainability Innovation, synergy, and sustainability are shaping the trajectory of India’s pharma sector, unlocking new frontiers of growth, inform industry stakeholders

Strategic M&As are reshaping the industry landscape

ndia's pharma industry, a global leader in generics, is poised for exponential growth. The sector is targeting a remarkable $130 billion by 2030 and a visionary $450 billion by 2047.

The shift in mindset to build a sustainable pharma industry will continue to drive innovations

Several key trends are shaping the industry’s trajectory include 1. Market consolidation: Strategic mergers and acquisitions, primarily backed by private equity, are reshaping the industry landscape. This consolidation empowers companies to scale operations, diversify into new therapies, and optimise supply chains to address pricing pressures and ensure sustainable growth. 2. Digital transformation/AI integration: Leveraging AI, data analytics, and digital platforms, the industry is streamlining operations, enhancing efficiency, and ensuring regulatory compliance. Moreover, these technologies are driving innovation in medicines’ access, personalised medicine, remote patient monitoring, and real-time health insights, improving patient outcomes and positioning India as a leader in the evolving healthcare ecosystem. 3. Government support/ Policy initiatives: The Indian government's supportive policies, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY) and the Production Linked Incentive (PLI) scheme, are acceler-

Rajeev Kumria, General Manager, H.E.L India

Yugal Sikri, MD, RPG Life Sciences

ating industry growth. PMJAY has expanded healthcare access, while PLI is boosting domestic manufacturing. The National Digital Health Mission (NDHM) is integrating various stakeholders on a digital platform, creating a world-class

healthcare ecosystem. The potential extension of the PLI scheme to biosimilars could further catalyse growth in this rapidly expanding segment. These trends will help India strengthen its position as a global pharma powerhouse.

025 will be a critical year in our mission to cut emissions in India to net zero by 2070, with a focus on transitioning to clean energy sources and increasing sustainable pharma manufacturing capabilities. A key driver behind this transformation will be an increase in process analytical technology (PAT): a mechanism by which researchers design, analyse, and control manufacturing processes to improve efficiency. Further advancements in automation software, including the incorporation of AIbased tools, will facilitate widewide scale adoption of PAT, easily integrating into existing workflows to enable ongoing monitoring and optimisation of manufacturing processes. Advances in automated par-

allel synthesis platforms will accelerate both R&D and industrial scale manufacturing, enabling rapid, accurate chemical synthesis, and facilitating decarbonisation of the industry. To further support the scale-up of sustainable pharma manufacturing, continual developments in calorimeters will allow for the production of accurate process safety data sheets (PSDS), a crucial tool for advancing industry standards. This recent shift in mindset to build a sustainable pharma industry will continue to drive innovations in process development instrumentation, maximising productivity and minimising risk in manufacturing as we simultaneously strive to reduce our environmental impact.

EXPRESS PHARMA

January 2025

cover ) SUPPLY CHAIN

Trends 2025: Redefining the pharma supply chain Saurabh Gupta, Global Head of Supply Chain, Lupin highlights trends such as AI integration, digitalisation and sustainability that are shaping a future-ready supply chain

upply chain management used to be simple—or at least it seemed that way. You produced goods, stored them, and shipped them out, hoping everything stayed on track. But today, the pharmaceutical supply chain has transformed and become more complex. It’s no longer just about moving products; it’s about resilience, sustainability, and delivering life-changing medicines to patients when they need them most. Looking ahead to 2025, we’re witnessing an industry in transformation. This isn’t just about keeping up—it’s about staying ahead. Let’s take a closer look at the trends shaping the supply chain of tomorrow.

AI-driven supply chains: From guesswork to precision There was a time when supply chain decisions were based on gut feelings and basic calculations and usually decisions were driven based on retrospective reviews. Those days are long gone. Today, artificial intelligence (AI) and machine learning (ML) are at the heart of supply chain operations. Generative AI for instance is transforming the supply chain by providing real-time responses to fluctuating market demand and providing insights into supply disruptions. With its predictive capabilities, AI empowers the supply chain to be more agile and adaptive. As an outcome, organisations today are better equipped to respond to the everchanging market dynamics. Companies that are using AI are equipped to handle logistical turmoil emanating from geo-political tensions and can respond faster to supply disruptions, avoiding stockouts and maintaining critical supplies. AI doesn’t replace humans; it amplifies

30 EXPRESS PHARMA January 2025

our capabilities, enabling us to make better, faster decisions.

Sustainability and ESG: A change of heart Not long ago, sustainability was an afterthought in supply chain management—nice to talk about but hard to act on. That’s changed. Today, sustainability is a core strategy for pharma companies. Companies are focusing on reducing air transport in export logistics, which enhances supply chain sustainability by lowering carbon emissions. Shifting to greener alternatives like sea, rail or road transportation has become a major priority for companies to minimise central environmental impacts while also lowering costs and promoting long-term operational efficiency. Effluent discharge has become a major lever that drives decisions pertaining to capability building and expansion. Product packaging has undergone major changes and now focuses on building sustainable capabilities to avoid dependence on ecofriendly materials.

Digitalisation and the power of digital twins One of the most exciting innova-

tions in supply chain management is the rise of digital twins— virtual models that mirror physical supply chains. Imagine being able to simulate a new manufacturing process or transportation route without disrupting actual operations. Digital twins make that possible. They allow companies to test scenarios, predict outcomes, and optimise centre performance in real-time. This kind of technology transforms how we plan and adapt. Instead of reacting to problems, supply chain teams can prevent them from happening in the first place. It’s like having a crystal ball for your supply chain.

Global complexities: Building resilience in a fragile world Global supply chains are more interconnected—and more fragile—than ever. Trade policies, geopolitical tensions, and economic shifts can disrupt operations overnight. To stay ahead, companies are diversifying their manufacturing and distribution networks. Instead of relying on one or two regions, they’re building operations across multiple

geographies. This approach reduces risk and ensures continuity when disruptions occur. Technology plays a vital role here. IoT sensors track shipments in real-time, alerting teams to delays or issues. Blockchain provides transparency, ensuring the authenticity of products and reducing the risk of counterfeit drugs entering the market.

recorded and verified. This ensures authenticity and builds confidence in the supply chain. While challenges like integrating blockchain with legacy systems remain, the potential to enhance transparency and patient safety makes it a promising technology for the future.

The cold chain challenge: Keeping it cool and green

With all the focus on technology, it’s easy to forget the most important part of the supply chain—people. As supply chains become more digital, the skills required to manage them are evolving. Companies are investing in upskilling their teams, and equipping employees with expertise in AI, analytics, and digital tools. At the same time, there’s a growing emphasis on fostering diverse, inclusive teams. Different perspectives lead to better solutions, especially in an increasingly complex global landscape.

Cold chain logistics—ensuring temperature-sensitive products like biologics, complex generics, etc., remain effective—has always been a tough nut to crack. But now, the challenge is to do it sustainably. IoT-enabled temperature monitoring has revolutionised centred cold chain logistics, providing real-time updates on shipments. If something goes wrong, the system immediately alerts the team, allowing them to act quickly. Companies are exploring eco-friendly solutions like Thermal Blanket, made from sustainable, recyclable or biodegradable materials for temperature-sensitive logistics. Meanwhile, companies are exploring eco-friendly solutions like energy-efficient refrigerants and sustainable packaging. These innovations are reducing environmental impact while maintaining the highest standards of safety and efficacy.

Blockchain: A trust revolution In an industry where trust is paramount, blockchain is emerging as a game-changer. Counterfeit drugs are a persistent threat, but blockchain’s immutable ledger offers a solution. Every transaction, from raw material sourcing to the final delivery of a product, can be

The talent transformation: The human side of innovation

Looking ahead: What 2025 holds Supply chain management has come a long way from its humble beginnings. What was once a behind-the-scenes function, is now a strategic driver of innovation and impact. As we look to 2025, the focus must be on building supply chains that are not just efficient but also resilient, sustainable, and deeply aligned with patient needs. This means embracing technology, prioritising sustainability, and putting people—patients and employees alike—at the heart of every decision. The future of pharmaceutical supply chains is bright, dynamic, and full of possibilities. While technology continues to lead the way, the human touch will always be at its core.

REPORT

KPMG 2024 Life Sciences CEO Outlook This recent KPMG report explores the perspectives and priorities of life sciences CEOs amid economic and geopolitical uncertainty, focusing on growth strategies, digital transformation, ESG goals, and workforce challenges. Excerpts from the report While economic and geopolitical uncertainty remain, life sciences CEOs are confident that their organisations can outgrow the industry and the economy. One fifth expect to see impressive growth — earnings growth above five per cent and one third expect headcount growth of six per cent or more. To deliver that, they expect to drive growth both organically and inorganically. In part, our survey reveals that CEOs expect new technologies — generative AI in particular — to help unlock new growth and innovation without increasing costs or talent requirements. They are hoping new technologies will help them to improve R&D, drive productivity and enhance efficiency. Yet they are also struggling with a number of challenges that are slowing progress. ESG and sustainability is another area where CEO ambition and ability are falling out of alignment. Life sciences CEOs clearly recognise the importance of meeting their ESG objectives and understand the impact failure would have on public trust. But they say they face challenges keeping up with shifting stakeholder expectations and worry they might miss their goals. A common theme across both areas — and on its own — is talent. CEOs say they lack the talent to deliver on the benefits of generative AI. And they say they do not have the capabilities required to achieve their net zero goals. Most say they struggle just to replace retiring employees. In this environment, life sciences CEOs will need to remain agile, make bold decisions and act with integrity. The following chapters explain why.

Growth and prosperity Life sciences CEOs are feeling bullish about their growth prospects. In our survey, 79 percent of CEOs say they are confi-

dent in the growth prospects of their company — up 10 percentage points from this time last year. Yet they are increasingly concerned about the health of the industry with just 67 per cent voicing confidence this year versus 80 per cent last year. Clearly, some have big ambitions to outgrow the competition. More than a third of our respondents say they will see earnings growth of more than 2.5 per cent over the next three years (20 per cent think they will achieve five percent or more growth). The vast majority (94 per cent) say they will increase headcount over the next three years and 37 per cent of the total think they will grow their workforce by six percent or more. Confidence may be up. But significant concerns still linger

related to growth prospects. In our survey, 57 per cent of CEOs say economic uncertainty remains top of mind. More than half (53 per cent) voice concerns about geopolitical complexity. This is not surprising — economic uncertainty influences everything from patient affordability through to investment funding and financing. The impacts of geopolitical complexity on life sciences supply chains are well documented.1 Perhaps not surprisingly, therefore, two-thirds of our respondents say they have already adapted their growth strategy to reflect their changing market environment. In some cases, this has likely been to respond to changes and updates to product portfolios — innovative technology-enabled solutions and next-

generation therapies, for example. Many others are simply responding to shifting market considerations and competitive pressures. So how do life sciences executives plan to grow? Both organic growth and M&A are high up the priority list. In fact, 46 percent of respondents say they are likely to undertake an acquisition which will have a significant impact on their organisation over the next three years. And they expect action on priorities such as digitalisation, ESG and talent will help them achieve their more organic growth objectives — topics we cover in more detail in the following chapters.

Gen AI and transformation Innovation is key to success in

life sciences. And our survey suggests sector CEOs are ramping up their investment into new technologies, digitalisation and AI in order to catalyse growth and innovation. Generative AI is a particularly hot topic. Consider this: despite high concerns about ongoing economic uncertainty, 60 percent of CEOs say that generative AI is their top investment priority. 58 per cent say they are putting more capital investment into new tech than they are into new workforce skills and capabilities. The CEOs surveyed say they

expect to see big value in creating new products and driving market growth, as well as boosts to innovation, efficiency and productivity, profitability, and workforce capabilities. More than three-quarters of respondents also say AI will help them create competitive advantages in the near future (77 per cent expect to see ROI in the next five years). Despite this positivity, life sciences CEOs feel there are significant risks and concerns with the still-emerging technology, with their biggest concern being around regulation. Indeed, 70 per cent of our respondents say that the pace of progress on generative AI regulations will be a barrier to their organisation’s overall success. 84 per cent say the current lack of regulation is challenging adoption of the technology. Life sciences leaders also have clear concerns about their organisations’ readiness to take on new forms of AI. In our survey, just 38 per cent are confident their data is ready for AI

EXPRESS PHARMA

January 2025

REPORT tion of talent. According to the international non-governmental organization, Health Care Without Harm, if the health sector were a country, it would be the fifth-largest emitter on the planet.3 The NGO indicates that 71 percent of the sector’s emissions primarily come from the health care supply chain through the production, transport and disposal of goods and services, such as pharmaceuticals, medical devices, hospital equipment and other items.4 Life sciences companies have a key role to play in the transition to net zero. Positioned in the middle of the value chain, life sciences companies’

and only 37 per cent think they have the right skills to fully leverage the technology. At the same time, CEOs are worried about the potential impact of the technology on their people, objectives and public trust. 86 per cent are concerned about the ethical challenges — bias, transparency, data privacy and so on. These concerns are warranted as a 2019 longitudinal examination of genome-wide

32 EXPRESS PHARMA January 2025

association studies from 2005 to 2018 revealed an extreme lack of diversity as approximately 88 per cent of the genomes used were of European ancestry.2 Life sciences leaders are also worried about other impacts of new AI models with a majority concerned about environmental impacts and nearly half concerned about the impact on their corporate culture. When it comes to the topic of digital transformation, cyber se-

curity is also a top concern. The inevitability of an attack is clear to sector CEOs. Three-quarters of our respondents say that cybercrime and cyber insecurity will likely negatively impact their organisation over the next three years. But they are also fairly confident in their preparations

— just 14 per cent of CEOs admitted they might be under-prepared for a cyber-attack and 46 per cent think they are well-prepared.

Sustainability and public trust Life sciences CEOs understand and recognise the link between sustainability and public trust. Indeed, in our research the top reason respondents say they have adopted an ESG strategy is to build customer relationships and create positive brand associations. Many also believe it will help them attract the next generation of talent and strengthen employee engagement. At the same time, CEOs recognise the important bottom-line benefits of a strong sustainability and ESG strategy. Almost one-infive say their ESG strategy helps them shape their capital allocations and M&A decisions. A similar number say it will help attract the next genera-

emissions are indirectly affected by activities of their upstream suppliers, such as raw materials and ingredients manufacturers, as well as the direct emissions produced by their own operations. However, our survey reveals that just 43 per cent of sector CEOs are confident they can meet their organisation’s net zero goals by 2030 (that is the second-lowest level of confidence amongst the 11 different sectors surveyed as part of this research). Life sciences leaders cite a lack of skills and expertise, the complexity of decarbonising their supply chains, challenges gathering and analysing data and problems, and setting up the right internal controls. What is clear is that CEOs are taking the challenge personally. In our survey, 61 per cent of CEOs say that — as confidence and trust in governments declines, the public is looking to

REPORT

METHODOLOGY T

he 10th edition of the KPMG CEO Outlook, surveyed 1,325 CEOs between 25 July and 29 August 2024, and provides unique insight into the mindset, strategies and planning tactics of CEOs. All respondents had annual revenues over $500 million and a third of the total companies surveyed had more than $10 billion in annual revenue. The survey included CEOs from 11 key markets (Australia, Canada, China, France, Germany, India, Italy, Japan, Spain, UK and US) and 11 industry sectors (asset management, automotive, banking, consumer and retail, energy, infrastructure, insurance, life sciences, manufacturing, technology, and telecommunications). NOTE: Some figures may not add up to 100 per cent due to rounding. This report draws on the views of 120 life sciences leaders. In the life sciences research, the two largest sub-sectors were pharmaceuticals (representing 45 per cent of respondents) and biotechnology (representing 19 per cent). The best-represented countries based on organisational headquarters were the US, Japan, India, China and Germany.

businesses to fill the void on societal challenges. And they are prepared to step up. More than two-thirds say they are willing to take a public stand on politically or socially contentious issues, even if their Boards were concerned about the risk. The problem is knowing what stand to take.

More than half of our respondents say that stakeholder expectations regarding ESG change faster than they can adapt their strategy. Given that 23 per cent worry that failure to meet expectations may be a threat to their continued tenure, it is a challenge they will quickly need to solve.

Workforce and talent With many life sciences organisations now looking to grow their workforces and competition for key skills and capabilities increasingly tight, many CEOs are sharpening their focus on attracting and retaining talent. The challenge for the sector is that most roles require highly

specialised skills and many key capabilities are learned on the job. Not surprisingly, therefore, CEOs in our survey say their number one workforce challenge is replacing retiring employees with skilled ones. Other challenges include knowledge transfer between employees and managing differences and ten-

sions resulting from corporate responses to social and global issues. As such, our survey suggests that life sciences organisations are implementing a variety of strategies to try to attract and retain the talent they require. As mentioned in the previous chapter, many organisations are looking to leverage their ESG strategy to attracting the next generation of talent. Improving organisational diversity will also clearly be a key strategy. In our survey, more than half of the respondents say that progress on diversity and inclusion has moved too slowly in the business world. And they believe that change must start at the highest levels — 83 per cent say that achieving gender equity in their C-suite will help them meet their growth ambitions and 78 per cent believe that achieving their diversity goals requires change across leadership at the senior level. 43 per cent of the life sciences leaders in our research are placing more capital investment in developing workforce skills and capabilities, seven percentage points higher than the average across the 11 sectors surveyed. Many are also turning to technology to address workforce challenges. Life sciences CEOs say the top three functional areas their organisations plan to make generative AI investments in over the next three years are sales and marketing, IT, R&D, and finance and accounting. Post-pandemic, where corporate employees work continues to be a hot topic. When looking to the future of work arrangements, the predictions of life sciences leaders are significantly more flexible than the CEOs in the 11 other sectors surveyed when it comes to hybrid working.

EXPRESS PHARMA

January 2025

Catalysing innovation and collaboration Experts and leaders from the pharma industry convened to spotlight Chennai’s pivotal role in India’s pharma landscape, addressing key issues to drive the sector's sustained growth and success

POST EVENT

Welcome Address E

xpress Pharma recently organised the inaugural edition of the Chennai Pharma Summit with a clear vision—to co-create an ecosystem that champions innovation, excellence, and growth within the pharma sector. The summit brought together industry leaders, innovators, and experts from Chennai to delve into the city’s rich heritage in manufacturing and its growing prominence as a hub of pharma excellence. Throughout the event, experts examined critical topics shaping the future of the pharma industry, including advancements in digital technologies, sustainable practices, regulatory complexities, and beyond. The summit also served as a vibrant platform for networking and collaboration, fostering meaningful connections among key stakeholders. The event commenced with a ceremonial lamp lighting, followed by a welcome address from Express Pharma, setting the tone for a day of impactful discussions and insights.

Lamplighting ceremony at Chennai Pharma Summit 2024

Innovations in active packaging

uring the Chennai Pharma Summit 2024, Dhairy Sharma, Sr Executive - Business Development, Cilicant, delivered an informative presentation on the latest innovations in active packaging technology and its significance for the pharma sector. He focused on how these advancements are pivotal in ensuring the stability, shelf life, and overall patient safety of pharma products. A key feature of the presentation was Accuflip, a humidity regulator developed by Cilicant. Sharma explained how this product plays a crucial role in maintaining optimal moisture levels in capsules, preventing them from becoming either too dry or overly moist. This level of humidity control is essential for ensuring the longterm stability and effectiveness of pharma products. He also spoke about

Accuflip, an ERH regulator, is designed to be used in primary packaging and prevents overdesiccation of formulations

Dhairy Sharma, Sr Executive - Business Development, Cilicant

FREXIL, Cilicant's dust-proof canisters, designed to resolve the common issue of dusting

in activated carbon-based canisters. These innovative canisters protect pharma prod-

ucts from potential contamination but also eliminates the dusting problem, ensuring the

cleanliness and safety of the packaging. The session concluded with valuable insights into how adopting Cilicant's smart active packaging solutions can optimise packaging strategies, elevate product quality, and enhance customer satisfaction.

EXPRESS PHARMA

January 2025

POST EVENT

Panel Discussion: Chennai's competitive edge and emerging leadership

L-R: Mahaveer Bafna, MD, Bafna Pharma; Sanjay Dasmohapatra, President - Technical, Medopharm; J Jayaseelan, Chairman, IDMA (Tamilnadu, Puduchery and Kerala) (Moderator); Dr SV Veeramani, MD, Fourrts India; and Sampathkumar Devarajan, ED & CSO, Axxlent Pharma Science

he Chennai Pharma Summit 2024 on December 20th saw a dynamic panel discussion on the theme 'Chennai's competitive edge and emerging leadership'. The session was moderated by Mr. J Jayaseelan, Chairman of the Indian Drug Manufacturers’ Association (IDMA) for Tamil Nadu, Puducherry, and Kerala, and featured an expert panel comprising Dr SV Veeramani, MD of Fourrts (India) Laboratories, Mahaveer Bafna, MD, Bafna Pharmaceuticals, Sampathkumar Devarajan, ED & CSO, Axxlent PharmaScience, and Sanjay Dasmohapatra, President – Technical, Medopharm. The discussion delved into

38 EXPRESS PHARMA January 2025

the growing prominence of Chennai and Tamil Nadu in the pharma and medical device sectors, highlighting the region's vast potential to emerge as a global hub for pharma R&D and innovation. A central theme was investment in research and development (R&D). Tamil Nadu's future in the pharma sector hinges on accelerating progress through strategic investments in R&D. The panelists unanimously agreed that fostering a robust innovation ecosystem is essential for staying competitive in an increasingly globalised market. They pointed out, companies that continue to focus on improving existing products and exploring new

therapeutic areas will be the ones to lead the charge in transforming Tamil Nadu into a key player in pharma innovation. The experts emphasised the need to identify and invest in niche segments that hold high growth potential as well. They suggested that Chennai has the resources and infrastructure to become a hub for biosimilars, which can serve both domestic and international markets. By focusing on these sustainable niches, the region could gain a competitive advantage in the evolving global pharma landscape. The panelists collectively agreed that the ability to maintain high-quality standards while fostering innovation will

be the differentiating factor for pharma companies in the future. This will require the collaboration of all stakeholders, including manufacturers, regulators, and R&D institutions, to create an environment that nurtures both. The session also focused on the power of knowledge sharing and the potential benefits of creating a more collaborative framework among industry players. Panelists highlighted that greater synergies between academia, industry, and regulatory bodies can drive growth. In a highly regulated sector like pharma, balancing cost with innovation is crucial. The panel discussed the challenges of maintaining cost-effective-

ness while simultaneously investing in cutting-edge technologies and processes. The panel concluded by reinforcing the importance of investment in high-growth areas such as biosimilars, specialty generics, and other innovative segments. The future of Chennai's pharma sector will depend on the region's ability to tap into these lucrative markets while maintaining a strong focus on quality, regulatory compliance, and innovation. In summary, the session underscored Chennai’s emerging leadership in the pharma sector, offering a roadmap for the city to solidify its position as a hub for pharma innovation, research, and development.

POST EVENT

Polymeric solutions for the pharma industry

t the Chennai Pharma Summit 2024, Kabirdas B, Sr Manager – Business Development, Ami Polymer, delivered an informative presentation on the vital role of polymer solutions in pharma manufacturing. He highlighted the wide range of polymer products offered by Ami Polymer, specifically designed to meet the rigorous demands of the pharma and biopharma industries. He emphasised the critical importance of selecting the right polymer-based components—such as tubing and hoses—to ensure drug safety, efficacy, and compliance with regulatory standards. He discussed the varying requirements of different drugs, explaining that each drug

demands specialised polymeric solutions for optimal performance in the production process. The presentation showcased products including silicone and fluoropolymer tubings. Kabirdas underscored that these solutions are developed to meet all quality standards and undergo strict testing, providing the pharma industry with dependable components. Concluding the session, he assured the audience that Ami Polymer is committed to continuously improving its offerings to meet the evolving needs of the pharma sector, positioning the company as a reliable partner in providing the right polymer solutions for drug manufacturing.

Kabirdas B, Sr Manager – Business Development, Ami Polymer

Nitrosamines and MCC

t the Chennai Pharma Summit 2024, Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries, delivered an insightful session titled 'Nitrosamines and MCC'. His presentation delved into the essential role that excipients play in maintaining the quality of pharmaceutical products while ensuring strict regulatory compliance. Dr Gothoskar focused on the growing concern around nitrosamines, a class of impurities that pose potential health risks. With regulatory authorities around the world intensifying their scrutiny of nitrosamine levels in pharma products, it has become increasingly critical for manufacturers to address this issue proactively. Dr Gothoskar emphasised that excipients, especially those used in tablet formulations, are pivotal in managing nitrosamine contamination. By carefully selecting excipi-

Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries

ents, manufacturers can reduce the risk of these impurities and ensure both regula-

tory compliance and product safety. This means that excipient selection should go beyond

factors like cost and availability to also consider chemical stability and purity.

The session also highlighted the significant role of Microcrystalline Cellulose (MCC), one of the most widely used excipients in the pharmaceutical industry. Dr Gothoskar described MCC as a versatile excipient with exceptional compressibility, binding properties, and the ability to enhance tablet integrity and stability. He shared examples demonstrating how MCC has proven effective in improving both production efficiency and the overall quality of the tablets across multiple batches. In his conclusion, Dr Gothoskar emphasised that Sigachi Industries stands as a trusted partner for pharma companies. The company offers not only high-quality excipients but also technical expertise to help manufacturers navigate the complexities of tablet formulation, mitigate regulatory challenges, and achieve consistent, high-quality outcomes.

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January 2025

POST EVENTS

FDA's computer software assurance: Anew approach to risk-based validation

he session on FDA Computer Software Assurance (CSA), held as part of Chennai Pharma Summit 2024, provided valuable insights into the evolving regulatory landscape for software validation in the pharma industry. The key focus was on how CSA represents a paradigm shift from traditional documentation-heavy validation approaches to a more streamlined, risk-based strategy that prioritises critical thinking and efficiency. One of the central themes of the session was the introduction of CSA as a means to establish confidence in the automation used in production or quality systems. The FDA’s stance on automation and the use of software products, including advanced technologies like AI/ML, was emphasised. These technologies, the FDA

Anand Rao C, VP - Quality Assurance, Navitas Life Sciences

suggests, hold immense potential for enhancing product quality, improving patient safety, and increasing operational efficiency across the entire product lifecycle. A major point discussed was the contrast between tra-

ditional Computer Software Validation (CSV) and the newer CSA approach. CSV is often criticised for its heavy documentation requirements, which can detract from critical testing and thinking. In contrast, CSA emphasises a more

efficient, risk-based testing process. The CSA risk management approach was also outlined in detail. The session detailed how different testing methods—scripted, unscripted, exploratory, and ad-hoc test-

ing—align with risk ratings to ensure the safety and reliability of the software. A particularly useful segment of the session was the discussion on leveraging vendor documentation. By assessing vendor capabilities and QMS, companies can optimise their validation strategy, focusing on validating critical functionalities while relying on vendorprovided documentation for less risky components. Overall, the session highlighted the transformative potential of CSA in biopharma, enabling streamlined validation processes, improved efficiency, and enhanced product quality and patient safety. With regulatory frameworks supporting innovation, the adoption of CSA principles can lead to more effective compliance strategies and foster continuous improvement in the industry.

Omega Scientific Instruments

Lenin Babu, MD, Omega Scientific Instruments gave an insightful overview of his company’s cutting-edge solutions for the pharmaceutical industry. His session commenced with a detailed introduction to Omega’s capabilities, highlighting its comprehensive service portfolio that spans consulting, design, fabrication, installation, and support. He informed that Omega, with its deep expertise in pharmaceutical biotech modules, has carved a niche with innovative and cost-effective solutions. The presentation also delved into omega’s diverse product range, such as its bioprocess equipment and water systems. Omega showcased its

40 EXPRESS PHARMA January 2025

N Lenin Babu, MD, Omega Scientific Instruments

in-house automation expertise rto provide robust validation documentation, ensure seamless operation and adherence to regulatory requirements. The session concluded with an emphasis on Omega’s meticulous approach, starting from understanding client requirements to commissioning the final product. The session highlighted Omega's technological prowess and positioned Omega as a trusted partner in aseptic bioprocess equipment manufacturing. The event provided valuable insights into Omega’s contributions to the pharma sector, showcasing how its solutions drive efficiency, reliability, and innovation in an increasingly competitive landscape.

POST EVENTS

Panel Discussion: Evolving Role of technology in enhancing manufacturing and quality assurance

Panelists: G Raghuraman, AGM - Quality, Bafna Pharmaceuticals (Moderator); Mathivanan Rajagopal, VP and Head – R&D, Axxlent Pharma Science; Dr Mohan Lakshminarayan, Director Operation & System, Fourrts (India) Laboratories; Sachin Sundar N, President - Plant Operations, Acumen Pharmaceuticals; Dr Ashok, GM-R&D, Bangalore Pharmaceutical and Research Laboratory; Dr J Suryakumar, Pharma Consultant & CEO, Technology Business Incubator

he last session of Chennai Pharma Summit 2024 was a thought-provoking panel discussion on 'Evolving Role of Technology in Enhancing Manufacturing and Quality Assurance.' The session brought together industry stalwarts to deliberate on how technology can revolutionise India's pharmacsector. The panel, moderated by G Raghuraman, AGM-Quality, Bafna Pharmaceuticals, also featured Mathivanan Rajagopal, VP and Head – R&D, Axxlent Pharma Science, Dr Mohan Lakshminarayan, Director - Operation & System, Fourrts (India) Laboratories, Sachin Sundar N, President Plant Operations, Acumen Pharmaceuticals, Dr Ashok,

GM-R&D, Bangalore Pharmaceutical and Research Laboratory, and Dr J Suryakumar, Pharma Consultant & CEO, Technology Business Incubator. The discussion underscored the potential of technology to boost efficiency, driving innovation, and ensuring quality assurance in the pharma manufacturing landscape. Speaking on innovation, the panellists emphasised that both breakthrough and incremental innovations are critical for India Pharma Inc.'s sustained growth. By embracing both, the sector can address immediate challenges while laying the groundwork for longterm advancements. They also rooted for effec-

tive data collection, analysis, and implementation emerged as a pivotal theme. Elaborating on how data analytics can help pharma companies manage market volatility and sharpen their competitive edge, the panellists highlighted the necessity of robust data management systems to maximise efficiency and ensure compliance with stringent regulatory standards. In a highly regulated and conservative industry, archiving documents accurately is crucial. So ,the discussion explored how advanced digital solutions can streamline document management, enhance transparency, and reduce compliance risks. The panellists stressed that

targeted investments in research and development could yield immense benefits for the industry, particularly in drug innovation and addressing unmet medical needs. There was a unanimous call for strategic partnerships and collaborations By bridging knowledge gaps, expediting drug development, and addressing global health challenges, these collaborations can significantly enhance the industry's global competitiveness, highighted the speakers. As the industry undergoes a transformation driven by technology, training and upskilling the workforce was deemed a non-negotiable priority. The panellists advocated for continuous education and develop-

ment programmes to prepare professionals for evolving technological demands. The discussion highlighted the immense potential of technology to elevate manufacturing and quality assurance standards in India's pharmaceutical sector. However, the panellists agreed that realising this potential requires a concerted focus on innovation, strategic investments, and fostering partnerships. As the Chennai Pharma Summit 2024 concluded, it reinforced the collective commitment of industry leaders to cocreate an ecosystem that leverages technology to drive sustainable growth and ensure quality excellence in the pharma sector.

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January 2025

POST EVENT

CHENNAI PHARMA SUMMIT 2024

42 EXPRESS PHARMA January 2025

POST EVENT

CHENNAI PHARMA SUMMIT 2024

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January 2025

POST EVENT

CHENNAI PHARMA SUMMIT 2024

44 EXPRESS PHARMA January 2025

INTERVIEW

We aim to strengthen our presence in Asian and MENA regions, with particular emphasis on India Matthias Poslovski, Chief Sales Officer, Optima Pharma, speaks on the company's evolution and shares insights on emerging trends like personalised medicine, digitalisation, and AI-driven technologies, while outlining his company's strategies for market expansion, particularly in Asia and MENA, with a focus on the Indian pharma sector, in an exclusive interaction with Lakshmipriya Nair You've been with Optima Pharma for over two decades, witnessing significant industry transformations? What have been the most pivotal milestones in the growth of Optima Pharma? Over the past two decades, I've had the privilege of witnessing Optima Pharma's remarkable transformation and growth. One of the most pivotal milestones has been our evolution from a preferred supplier to a strategic partner and an integrated system provider of renowned international companies. This shift allowed us to offer comprehensive turnkey solutions, including fill and finish lines with isolator technology and freeze-dryers, catering to the increasingly complex needs of the pharma industry. By integrating advanced technologies and aligning closely with customer requirements, we provide complete turnkey systems, positioning us as a trusted partner in the industry. As a trusted partner we support our customers from the initial development and throughout the entire life cycle of the system by providing a unique blend of industry and applications expertise, technology proficiency, as well as process and service quality. Additionally, our strong internationalisation efforts over the past 20 years have

46 EXPRESS PHARMA January 2025

been crucial in driving growth. Expanding our global presence has enabled us to serve a more diverse customer base, adapt to regional market demands, and stay at the forefront of industry advancements worldwide.

What are the major trends in the pharma filling and packaging industry? Where is it headed in the next five to ten years? The pharma filling and packaging industry is evolving rapidly, driven by several key

trends. One major direction is the growing demand for holistic turnkey systems, including isolator technologies for maximum product safety and sterility. Digitalisation is also playing an increasingly significant role, optimising various process steps, from monitoring and control to predictive maintenance. In parallel, there is a strong focus on minimising glove interventions and minimising pharma risk. The combination of innovative technologies like AI, simulation, and robotics creates new solutions reducing contamination risks and improving efficiency. The industry is also adapting to the challenges of handling high-potent products, particularly ADCs, and addressing the growing demand for vaccines, including GLP-1-related products. Looking ahead, the rise of personalised medicine is reshaping production. Tailored therapies, especially for rare diseases and treatments for children with oncological and immunological conditions, require flexible, modular systems that enable the separation and automation of complex manufacturing processes. What are the factors driving your strategy today? How does Optima Pharma stay

ahead in a competitive global market with evolving regulatory landscapes and customer expectations? Our alignment as a strategic partner with integrated system solutions is determined by the increasingly complex requirements of the pharma industry, such as the expanded Annex 1 guidelines, and increasing customer expectations. Customers demand not only cutting-edge solutions but also holistic, seamless service throughout the lifecycle of their systems. For example, in the after-sales area, comprehensive support for complete turnkey lines is now a standard expectation. To meet these demands, we are continuously expanding our global service capabilities, offering localised, fullspectrum support worldwide. As a turnkey provider delivering isolators, filling machines, and freeze dryers from a single source, our Comprehensive Scientific Process Engineering (CSPE) approach plays a critical role in staying ahead. This scientifical methodology, refined by extensive experience, greatly shortens the path from design to production. By continuously refining CSPE, we ensure that our solutions meet the dynamic needs of our customers efficiently and reliably. This combination of a

customer-centric, regulatoryminded strategy and innovative execution ensures that Optima Pharma remains competitive in a fast-changing global market. What strategies have proven most effective in entering and scaling in diverse international markets? One of the most effective strategies for entering and scaling in diverse international markets has again been our focus on delivering turnkey solutions, supported by our CSPE approach. This allows us to provide integrated systems that meet the specific needs of each market while significantly reducing the time to production and providing maximum of safety by a complete tested system. Equally important has been the establishment of local service hubs and partnerships to ensure customers receive comprehensive, on-the-ground support. By building service capacities in key regions, we provide faster response times, tailored maintenance, and ongoing support for turnkey lines, which are critical for our customers' success in highly regulated and competitive markets. This dual strategy-offering advanced turnkey solutions and strengthening localised service networks-has been instrumental in driving our global growth and maintaining strong customer relationships worldwide. How are emerging technologies like AI, IoT and robotics shaping the future of pharma packaging solutions at Optima? Emerging technologies like AI, IoT, and robotics are profoundly shaping the future of pharma packaging solutions at Optima. AI, in particular, plays a crucial role in developing innovative solutions to minimise human interventions, such as glove interactions, which significantly reduces contamination risks. Automated and autonomously executed process steps powered by AI not only enhance safety but also

customised solutions that drive their success.

improve efficiency. Additionally, IoT enables realtime monitoring and predictive maintenance, optimising machine uptime and performance, while robotics enhances precision and consistency in handling complex tasks. By integrating these technologies, Optima ensures our solutions remain at the cutting edge, addressing both current challenges and future needs in the pharma industry.

How does Optima tailor its solutions to meet the unique needs of different regions while maintaining global standards? Could you share insights into how Optima collaborates with its clients to develop customised solutions? Optima fosters close partnerships with its clients, placing a strong emphasis on developing tailored solutions that meet their unique needs. Our approach centers on

finding comprehensive solutions with and for our customers. From the very beginning, we are deeply involved, providing holistic consulting expertise already from conceptual phase on. This ensures that every component of the turnkey line is seamlessly integrated and optimised. Collaboration is at the heart of this process; we actively engage with our clients, listening to their specific needs and challenges to co-create

What's next for Optima Pharma in terms of product innovation and market expansion? We are focused on advancements both in product innovation and market expansion. For example, we aim to strengthen our presence in the Asian and MENA regions, with particular emphasis on India. The Indian pharma market holds tremendous potential, especially in the generics sector. On the innovation front, we are driving the development of cutting-edge solutions for small batch manufacturing and personalised medicine like cell and gene therapies. Additionally, we are advancing technologies such as 100 per cent in-process control (IPC) for syringe processing, implementing new digitalisation solutions, and developing state-of-the-art technologies to minimise glove interventions. Our efforts also focus on creating even more flexible machine solutions to meet evolving market demands and ensure that we remain at the forefront of pharma manufacturing technology. lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com

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January 2025

INTERVIEW

CILICANT is changing the way we think about active packaging Team CILICANT shared insights into their journey of innovation, customer-centric solutions, and their ambitious plans for global expansion. In this engaging dialogue, the team also shed light on their unique value proposition, recent achievements, and strategies for adapting to a rapidly evolving pharma landscape, in an exclusive conversation with Express Pharma

What is CILICANT's vision for the future of active pharma packaging, and how do you see it contributing to the overall goals of the pharma industry? Active packaging does more than maintain stability; it empowers the pharma industry to deliver medications that are safer and more effective. CILICANT is changing the way we think about active packaging, making it a key player in healthcare

48 EXPRESS PHARMA January 2025

innovation. Our focus spans globally, touching markets from the US to the EU, and we strive to innovate persistently. We are committed to crafting solutions that address both traditional and specific customer challenges with precision and practicality. Sustainability is a critical element of our strategy. Though our steps are gradual, we never compromise on using environmentally friendly materials and processes. Every small step we take is

part of our larger mission to reshape the packaging industry to meet the demands of a changing world. Could you elaborate on CILICANT's unique value proposition? How do you differentiate yourselves from competitors? Where CILICANT shines is by meeting real world challenges with creativity and exactness. We do more than just active packaging; we create solutions customised to fit individual

customer needs. This enables us to deal with the classic as well as emergent challenges in an effective manner. Take Accuflip and Frexil, for instance. Here, ACCUFLIP an ERH regulator, tries to control the environmental aspects with unmatched precision in order for products to stay intact even if the RH conditions fluctuate. FREXIL, an activated carbon-based desiccant canister on its part, addresses common issues related to dust resulting from

activated carbon canisters whilst adsorbing odour and moisture, thereby making them easier and safer to use. These are representative of us thinking ahead of others by solving problems they may even not consider. What really makes us stand out, though, is our close partnership with our customers. Here we learn about their specific needs so that we can co-create a solution that not only happens to be practical and effective

INTERVIEW but also ready for what's to come next in terms of demand. A strong commitment to partnership as well as outstanding performance helps us become the go-to leader in the marketplace. What recent innovations or product developments have driven growth for CILICANT, and how have they been received by your clients? Innovation is the heartbeat of CILICANT, and it's the ideal that drives growth and guides our latest achievements in active packaging solutions such as Accuflip, Frexil and Oxabide. Such achievements are more than a mere productthey're the culmination of intense collaboration with our clients, during which we attentively listen to the problems they are trying to overcome, grasp all aspects of their needs, and apply ourselves to create technology addressing genuine world problems. Client reactions are overwhelmingly positive, and this fuels our zeal for further innovations. Winning the India Pharma Awards was a highlight for us, as it reaffirmed our commitment to push the boundaries of innovation and excellence. The nomination was very thorough, involving in-depth internal reviews and peer feedback. Earning this recognition was truly the icing on the cake, showing the hard work, teamwork, and dedication that define our approach at CILICANT. How does CILICANT assess emerging trends and adapt its business strategy to remain competitive and responsive to industry needs? The pharma landscape is dynamic, continuously evolving with new trends and challenges. CILICANT stays ahead by actively monitoring industry developments and maintaining open communication with customers and industry experts. This proactive approach helps us spot trends early and tailor our strategies

We want to expand our wings, and our base in US, Europe and UAE markets Manish Jain MD

Our team at CILICANT - be it Sales, Marketing or R&D everyone listens to the customer, so we understand the criticality of the product

access to the latest technologies and deeper understanding of the industry, and we co-create solutions for complex challenges. This relationship therefore allows us to closely work together with our customers to understand all their different needs and, consequently, come up with solutions best suited for their objectives - be it dealing with unique challenges in active packaging or enhanced product performance. Collaborative efforts ensure innovations are practical as well as impactful. These partnerships have been the foundation of trust and shared success, continually driving us to innovate and lead in our field.

Fahmim Hussain Marketing Director

As CILICANT, we always prefer that we're not selling the product to the manufacturer; we're selling this product to the end-consumer Sumeet Sharma Director Sales

Active packaging needs to evolve as per requirements and concerns in the market. CILICANT continuously strives to bring innovative active packaging solutions for the industry Komal Bhavsar AGM Business Development

effectively. Our strategy blends advanced analytics with deep market insights. By analysing data and engaging directly with clients, we grasp both the broad trends shaping the industry and the specific challenges our customers face. For example, the increasing importance of biologics and

personalised medicine has underscored the need for specialised active packaging solutions that offer precise environmental control. We've tailored our offerings to meet these demands, ensuring that our customers are wellprepared for the future. Can you discuss any

partnerships or collaborations that have been instrumental in CILICANT’s journey? At CILICANT, collaboration is the core of everything we do. We have fueled our growth and enriched our insights by partnering with research institutions, tech innovators, and industry leaders. We get

How does CILICANT plan to scale its operations globally, and what markets are you targeting for expansion over the next few years? As CILICANT enters the global arena, it will embrace an exciting expansion into key markets from the US to the EU, where the demand for innovative active packaging solutions is soaring. These areas are a natural fit for us because of their large pharmaceutical sectors and strict regulatory environments. With all this in mind, investing in local manufacturing units as well as sales offices gives us an opportunity to make our presence felt globally. As quick service is the key requirement within all these regions, it thus helps in making us grasp the individual aspects of different markets and also helps us build stronger, more personal connections with our clients. We're not stopping at healthcare. We are looking into other dynamic industries, such as food, agriculture, electronics, engineering, leather, and textiles. Here, our advanced active packaging solutions can make a significant difference. Diversifying our offerings and drawing on our deep industry knowledge, sets us on the path to becoming a global leader in active packaging.

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OsmoTECH® XT Single - Sample Micro-Osmometer Now available! Best-in-class osmolality performance, designed with you in mind.

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Offers the widest range of osmolality testing (0 – 4000 mOsm/kg H2O) Supports 21 CFR part 11, GMP and EU Annex 11 compliance Meets Pharmacopeia osmolality testing guidelines 3 Level user access and password protection Storage: unlimited data storage for access Audit trail: Preserve unlimited results and events Database backup, protects your data with automatic or manual backup

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PHARMA PULSE

PRUV® -The original Sodium Stearyl Fumarate JRS Pharma’s PRUV® is the original sodium stearyl fumarate (SSF) introduced in the market over 20 years ago

harma lubricants are the inactive agents i.e. excipients added into tablet and capsule formulations in a very small quantity (usually 0.25-5.0 % w/w) to improve the processing properties of formulations. They decrease the friction at the interface between tablet’s surface and the die wall during the compression and ejection phase of the tableting so that the wear on punches and dies are reduced. They prevent sticking of tablets to punch faces as well as sticking of capsules to dosators and tamping pins. In terms of powder flow, lubricants can improve the flowability of blends and aid unit operations [1]. A good balance between hydrophobic and hydrophilic moieties in PRUV® (Sodium Stearyl Fumarate) makes it an ideal lubricant [2].

Common lubricants used in drug development Most of the lubricants used in the pharma processes are boundary lubricants. Certainly, metallic salts of fatty acids such as magnesium stearate; stearic acid and sodium salt of fatty acid such as sodium stearyl fumarate are the most common ones. A. Fatty acid esters: Fatty acid esters, including glyceride esters (glyceryl monostearate, glyceryl tribehenate, and glyceryl dibehenate), sugar esters (sorbitan monostearate and sucrose monopalmitate) and alcohol ester of stearic alcohol with fumaric acid, including sodium stearyl fumarate are often used as lubricants. In particular, sodium stearyl fumarate and glyceryl dibehenate are effective lubricants to replace magnesium stearate when the latter hampers dissolution and has chemical incompatibility issues. Relative to magnesium stearate, sodium stearyl fumarate has similar lubrication efficiency with a higher optimal concentration (around 2%,

occurs. Structurally, the lubricants commonly used for boundary lubrication are long chain molecules with active end-groups. The typical endgroups include: 1. –OH (long chain alcohol); 2. –NH2 (long chain amine); 3. –COOH (long chain fatty acids); and 4. Metal ions such as Mg2+.

Lipophilic Chain

Hydrophilic chain

w/w). In addition, the use of sodium stearyl fumarate does not affect compressibility [1]. B. Metallic salts of fatty acids: Use of the metallic salts of fatty acids as lubricants has a long history in the pharma industry and they are still the most dominant class of lubricants. Magnesium stearate, calcium stearate and zinc stearate are the three common metallic salts of fatty acids used [1] . C. Fatty acids: Fatty acids are also common lubricants used in the pharma industry with stearic acid as the most popular one. Chemically, stearic acid is a straight-chain saturated monobasic acid found in animal fats and in varying degrees in cotton seed, corn and coco. The commercial material of stearic acid has other minor fatty acid constituents such as myristic acid and palmitic acid [1]. D. Inorganic materials and polymers: Inorganic materials and polymers are also used as lubricants when magnesium stearate cannot be used. In terms of inorganic materials, talc (a hydrated magnesium silicate (Mg3Si4O10(OH)2), is often used as a lubricant or as a glidant in formulations. Talc provides some essential lubricity for pharma operations because of its hydrophobicity and weakly bonded sheet structure [1][6] .

Mechanism of lubrication: There are four lubrication mechanisms: [1] 1. Hydrodynamic lubrication,

2. Elasto-hydrodynamic lubrication, 3. Mixed lubrication, and 4. Boundary lubrication. As their names imply, the first three mechanisms are related to the usage of liquid lubricants to some extent. In the pharma industry, boundary lubrication is the most common mechanism functioning in unit operations.

Considerations for selecting a lubricant There are many factors to be considered for selecting an appropriate lubricant for preparing solid dosage forms, including low shear strength, being able to form a durable layer covering the surface/particles, non-toxic, chemically compatible with APIs and other components in the formulation, low batch-to-batch variability, and

Typical properties of PRUV®: [5] pH

About 8.5 (10% aqueous solution at 900C)

PRUV® (Sodium Stearyl Fumarate) characteristics: ◆ Highly efficient lubricant and anti-adherant ◆ More water-soluble than Magnesium stearate ◆ Well-defined particle size and specific surface area ◆ High melting point (230°C) ◆ Lamellar structure ◆ High purity and batch-tobatch consistency

How PRUV® works?

Saponification value 142.2-146.0 Moisture

<5.0%

Solubility

0.5mg/100 ml at 250C/ 10 g/100 ml at 800C 20 g/100 ml at 900C

Melting point

consideration when selecting a lubricant because both of these two parameters greatly affect the performance of pharma products and processes. [1][6]. After understanding what are lubricants, commonly used lubricants in pharma formulation, mechanism of lubricants and considerations for selecting the best lubricant, let’s focus on more detail regarding PRUV® (Sodium Stearyl Fumarate) lubricant from JRS Pharma.

224-2450C

◆ PRUV® reduces inter-particulate friction during tablet manufacturing while acting as a boundary lubricant in the formulation. ◆ PRUV® facilitates lubrication during blending through shearing. ◆ PRUV® is more hydrophilic, dissolution is not compromised wherever facing dissolution issue with magnesium stearate. ◆ PRUV® goes beyond lubrication and it also accelerates dissolution.

Applications of PRUV®

SEM Picture of PRUV®

For boundary lubrication, a lubricant typically forms layers/film between surfaces or at interfaces to reduce friction, where the penetration of the lubricant into surface asperities

having minimum adverse effects on the performance of the finished dosage forms. [1][3] In addition, the optimal concentration and mixing time are also needed to be taken into

PRUV® can be used in dry granulation as well as wet granulation technology to avoid sticking of intra-granular blend to roller or RMG wall. PRUV® can also be used in capsule dosage by reducing friction between the particles. PRUV® is a perfect lubricant for highspeed tableting/continuous manufacturing because it is less sensitive to heat. PRUV® can also be used in hot melt

EXPRESS PHARMA

January 2025

PHARMA PULSE extrusion due to its higher melting point (224-245oC). Following are the case studies of PRUV® to evaluate the effect on physio-chemical properties on tablet dosage form [4]. In this study, the effect of different lubricants on Acetaminophen formulation was studied. Acetaminophen API blended with PROSOLV SMCC HD 90 for 15 min and afterwards blended with sieved lubricants for three minutes. Different lubricants like PRUV,

Magnesium stearate, stearic acid and sodium stearate are used. Tablets were compressed to 800 mg weight. tablet. Magnesium stearate is the most widely used lubricant in the pharma industry. Hence, PRUV® is compared with Magnesium stearate in the following section: PRUV® helps to avoid API incompatibilities and enhances API stability. With a few exceptions, PRUV® can be applied to any formulation for lubrication,

Ingredients

Quantity (%) Quantity (mg/unit)

Acetaminophen

62.5%

500 mg

PROSOLV® SMCC HD 90 35.5%

248 mg

Lubricant

2.0%

16 mg

Total

100.0%

800 mg

particularly those in which API stability or tablet taste is compromised due to magnesium stearate. Magnesium cation (Mg2+) is electrophilic, it interacts with the free electrons of an API and forms insoluble salts. This is one of the many causes of API incompatibility with magnesium stearate. [4] Electrostatic Properties: Magnesium stearate shows higher voltage and retention time than PRUV®. Low electric charge and retention improve lubricant dispersion during blending. As a result, PRUV® due to its low voltage and retention can be considered a superior lubricant with improved lubricant uniformity. PRUV® was carefully designed to consistently deliver the following functional characteristics:

LUBRICANTS: PRUV® (SODIUM STEARYL FUMARATE), MAGNESIUM STEARATE, STEARIC ACID, SODIUM STEARATE) Tablet Hardness/Compactability In this study, the effect of different lubricant on tablet hardness was evaluated

Lubrication efficiency In this study, the effect of lubrication efficiency of different lubricants was evaluated

Observation: The kind of lubricant used had a significant influence on the hardness of the tablets. While tablet lubricated with stearic acid resulted in the highest tablet hardness, those made from magnesium stearate exhibited the lowest hardness. Tablets made from PRUV show intermediate hardness.

Observation: As for compactibility, a similar trend observed in the ejection forces. The tablets lubricated with stearic acid showed the highest ejection forces, while magnesium stearate was found on the lower end of the ejection force spectrum. Tablets made with PRUV exhibited the same low ejection forces as compared to magnesium stearate.

Disintegration time In this study, the effect of different lubricant on disintegration time was evaluated

Dissolution behaviour In this study, the effect of different lubricants on dissolution behaviour was evaluated

Grade

D(50)

BET

SSF Micronized

7.6

4.2 m2/g

PRUV®

13.6

1.6 m2/g

PRUV® CG (Coarse Grade)

20.4

0.6 m2/g

PARTICLE SIZE AND SPECIFIC SURFACE AREA FOR DIFFERENT GRADES OF SSF[4]

With a few exceptions, PRUV® can be applied to any formulation for lubrication, particularly those in which API stability or tablet taste is compromised due to magnesium stearate ◆ Tight particle size distribution ◆ Well-defined specific surface area ◆ Reproducible particle morphology The outstanding performance of PRUV® is based on its well-controlled particle size and shape. Following studies show the effect of deviating from the ideal values.

Conclusion:

Observation: Tablets lubricated with magnesium stearate needed by far the longest time for disintegration. All other tablets were found to have disintegration times in the same range

72 EXPRESS PHARMA January 2025

Observation: Tablets containing magnesium stearate showed by far the slowest dissolution rates. Sodium stearate and stearic acid-lubricated tablets released the API much faster. The faster drug release was observed for tablets lubricated with PRUV®

Beyond tablet lubrication properties of PRUV®: It shows: ◆ Improved API stability ◆ Superior blending properties ◆ Faster disintegration ◆ Faster dissolution times The choice of lubricant can influence the quality of the tablets as well as the dissolution rates. Since APIs tend to be less water-soluble and difficult to compress, choosing the

right lubricants continues to become an even more important task. Most commonly available lubricants are very hydrophobic and thus increase dissolution times significantly. In such cases, a less hydrophobic lubricant can help to decrease the dissolution times as well as increase the API release. PRUV® Sodium Stearyl Fumarate complies with Ph.Eur., NF and JPE. It has the ideal particle size and specific surface area to offer a perfect balance between all functionality aspects. It is the preferred choice over magnesium stearate in terms of improving disintegration time and dissolution. Furthermore, different particle sizes are available, which help to fine tune tablet formulation resulting in the desired dissolution profiles.

PHARMA PULSE Regulatory status of PRUV®: ◆ Ph.Eur., NF, JPE, GRAS status ◆ C-DMF is available for PRUV® ◆ Non-animal origin ◆ BSE/TSE-free ◆ GMO-free ◆ OVI-free (USP<467>) and conforms to the residual solvents requirement of Ph.Eur.(5.4) and USP <467> ◆ QBD dossier available ◆ Elemental impurity statement available

References: 1. Jinjiang Li, Yongmei Wu. Lubricants in Pharmaceutical Solid Dosage Forms. Lubricants 2014, 2, 21-43. 2. Sonja Bauhuber, Maria Launer, Gernot warnke.Influence of Different Lubricants on Tableting Characteristics and Dissolution Behavior. Influence

of Different Lubricants on Tableting Characteristics and Dissolution Behavior- JRS Pharma https://www.jrspharma.com/ph arma_en/technicalinfo/brochures/technical-info/lubricants.php 3. Hölzer, A.W, Sjögren, J. EvaluQR Code: Scan the QR code for more details regarding PRUV® from JRS Pharma.

ation of sodium stearyl fumarate as a tablet lubricant. Int. J. Pharm.1979, 2, 145–153. 4. JRS Pharma PRUV® | Sodium Stearyl Fumarate- JRS Pharma https://www.jrspharma.com/ph

arma_en/products-services/excipients/lubricants/pruv.php 5. Rowe, R.C., Sheskey, P.J.; Quinn, M.E. (2009) Handbook of Pharmaceutical Excipients. 6th Edition, Pharmaceutical Press,

667-669. 6. Leon Lachman, Herbert A. Lieberman, Joseph L. Kanig. The theory and Practice of Industrial Pharmacy, Varghese publication house, 3rd edition, 1990, 123-144.

Mr Prashant Bhangdiya Technical Manager, Pharma Business unit, Rettenmaier India

Prashant Bhangdiya, Technical Manager, Pharma Business Unit, Rettenmaier India, is responsible for the JRS Pharma’s Excipients Business in South India, East India and Bangladesh, including but not limited to, supporting the business development team, customer service and logistics team. He completed M Pharmacy from Poona College of Pharmacy, Pune (Bharati vidyapeeth). He has also completed Diploma in Intellectual Property (IP) rights from Symbiosis International, Pune. He has over 10 years of experience in the field of formulation development and pharma excipients.

EXPRESS PHARMA

January 2025

PHARMA PULSE

Innovative bio-pharmaceutical mixing bag Manufactured in a controlled environment, Ami Polymer's mixer bags are produced in an ISO Class 7 clean room, where every step of the process, from raw material sourcing to final product output, is meticulously monitored to meet the highest quality standards, informs Chandan Sah, Deputy GM - Business Development, Ami Polymer

mi Polymer mixer bags are specifically designed to meet the rigorous demands of the bio-pharmaceutical and single-use disposable industries. Engineered for superior performance, these bags are offered in a variety of internal dimensions, ensuring optimal compatibility with your unique process requirements. Manufactured in a controlled environment, our mixer bags are produced in an ISO Class 7 clean room, where every step of the process, from raw material sourcing to final product output, is meticulously monitored to meet the highest quality standards.

Ami Polymer mixer bags are designed to meet the exacting demands of the bio-pharmaceutical and single-use disposable industries. For example, consider a biotech company developing a new vaccine: the precision and reliability of the mixing process is critical to ensuring product consistency and quality. Our mixer bags, available in a variety of internal dimensions, are engineered to optimize this process- whether it's for large-

maceutical mixing. Whether you're working with biologics, vaccines, or cell therapies, our solution is tailored to deliver optimal results every time. ◆ ISO 117 37-1 ◆ USP <88> Biological reactivity tests, In Vivo ◆ USP <87> Biological reactivity tests, In Vitro ◆ USP <85> ◆ USP <788> ◆ USP <661> ◆ Extractable

Characteristics ◆ ISO Class 7 clean room manufacturing: Our mixer bags are produced in a state-of-the-art, ISO Class 7 clean room, ensuring that each product meets the strictest standards of quality and sterility. ◆ Quality commitment: We maintain a robust quality assurance system, fully compliant with current Good Manufacturing Practices (cGMP), so you can trust that our products meet the highest industry standards. ◆ Global reach: With advanced technology and expanded facilities, we are able to provide top-tier mixing solutions to biopharmaceutical companies worldwide.

◆ Built for durability: High burst strength materials provide exceptional reliability, even under demanding conditions, ensuring long-term durability. ◆ 100 per cent integrity testing: Each bag undergoes a rigorous pressure leak test, guaranteeing 100 per cent integrity before use. ◆ Superior protection for product molecules: Our mixer bags offer excellent protection for sensitive bio-pharmaceuti-

cal components, minimising the risk of contamination or degradation. ◆ User-friendly connections: Convenient inlet and outlet connections make setup and operation easy, saving you time and effort.

APPLICATIONS APPL Mixer bags can be used in process and transfer of Precision mixing for biopharmaceuticals: A reliable solution for critical applications

CERTIFICATIONS:- SIZE AVAILABLE:Size

Catalogue no. With Powder Port

Without Powder port

50L

3D-MB-050L-0401

3D-MB-050L-0402

100L

3D-MB-100L-0401

3D-MB-100L-0402

200L

3D-MB-200L-0401

3D-MB-200L-0402

500L

3D-MB-500L-0401

3D-MB-500L-0402

650L

3D-MB-650L-0401

3D-MB-650L-0402

1000L

3D-MB-1000L-0401

3D-MB-1000L-0402

Features & Benefits ◆ Tailored to specific applications: Custom-designed to meet the precise needs of your process, ensuring optimal performance and reliability. ◆ Precision impeller for consistent mixing: The advanced impeller design ensures homogeneous mixing, enhancing process efficiency and consistency.

74 EXPRESS PHARMA January 2025

scale cell culture or small batch production. Manufactured in an ISO Class 7 clean room, our mixer bags undergo strict controls throughout every stage of production, from the selection of raw materials to the final product. This level of precision guarantees that each bag meets the highest standards, ensuring the integrity of your process and the protection of sensitive biological components. Just as a pharmaceutical company wouldn't risk compromising the sterility of their sterile drug formulations, our mixer bags provide the same level of assurance in bio-phar-

◆ US FDA 21 CFR Part 210.3 (b) (6) ◆ 100% Integrity tested Contact Chandan Sah Deputy General Manager Business Development 9512288895 chandan.s@amipolymer.com

PHARMA PULSE

Revolutionising pharma the adaptive way Adaptive manufacturing offers better performance, efficient management of diverse products, a reduced machine footprint, faster batch changes, and enhanced operational sustainability

harmaceutical manufacturing is undergoing a transformative development, driven by innovative technologies that enable right-first time (RFT) production and adaptive scaling to meet changing demands. By embracing smart manufacturing, the industry is addressing numerous challenges, allowing consumers to receive life-saving drugs more quickly and sustainably. The increasing market volatility highlights the necessity for a fresh, flexible production strategy that capitalises on the current market conditions. Thus, adopting advanced technologies not only enhances operational efficiency and flexibility but also leads to substantial cost savings. A more agile, adaptable, and environmentally conscious approach to manufacturing processes positions manufacturers to better seize opportunities and lower risks. Serialisation regulations now require pharmaceutical producers to ensure that any customisation they make is flexible, responsive, and adaptable. Customisation is the latest trend in the industry, and adaptive manufacturing demonstrates its effectiveness in meeting the growing and unpredictable demands.

A new way of manufacturing Adaptive manufacturing is revolutionising the pharmaceutical industry by leveraging the endless possibilities of smart manufacturing. This approach offers better performance, efficient management of diverse products, a reduced machine footprint, faster batch changes, and enhanced operational sustainability. Despite ongoing digitisation initiatives, the pharmaceutical sector has the possibilities to expand its use of automated and digital technologies. By eliminating the need for labor-intensive testing and establishing datadriven, error-resistant operations, the latest developments in advanced manufacturing tech-

Fig.1:- Adaptive enabling technologies

nology can save time and effort spent on legacy tasks. Additionally, the speed and flexibility needed to thrive in the present competitive environment cannot be provided by traditional techniques of production system installation or reactive manufacturing planning. The industrial approach must be modernised if long-term success is to be achieved. Some pharmaceutical companies have already adopted continuous manufacturing processes for their drugs, significantly reducing production times and improving quality control. This method allows for realtime monitoring and adjustments, ensuring consistent product quality. while some are integrating digital twin technology to create virtual replicas of manufacturing processes enabling companies to simulate and optimise production lines, leading to more efficient and flexible operations. B&R is collaborating and co-creating with OEMs, machine manufacturers and end users in pharma sector to offer training and development support to system and automation engineers in their firm. These give machine makers a significant advantage in gaining

confidence and using flexible approaches that can increase their market share. To stay ahead, the industry must evolve with adaptive technologies. Adaptive machines, with their ability to adapt and sustain themselves, offer a contemporary perspective on machine automation, paving the way for a more intelligent and efficient future in pharmaceutical manufacturing.

Why is adaptive manufacturing necessary? Historically, manufacturing has focused on productivity, efficiency, and economies of scale. However, today's consumers and markets demand flexibility, which is becoming the driving factor for many manufacturers. Flexible manufacturing systems (FMS), introduced 10-15 years ago, were designed to handle multiple products on the same line, but these products had to be known in advance and their requirements built into the process. Adaptive manufacturing takes flexibility to a whole new level. It makes switching batches not just possible, but effortless and instantaneous. With full control over individual products, for-

mats can be changed every cycle if needed. Adaptive manufacturing allows for the handling of unforeseen future products and running multiple SKUs (stock keeping units) in the same batch. While flexibility can be achieved with servo controls alone, adaptivity brings a new set of capabilities that emerge when incorporating key enabling technologies like mechatronic transport, robotics, machine vision, and simulation. Flexibility offers freedom within certain boundaries, but adaptive manufacturing removes those boundaries entirely. This challenges us to rethink how products are made, assembled, and packaged. Key factors of adaptive manufacturing: 1. Zero downtime changeover: Adaptive manufacturing systems enable seamless transitions between different products without any downtime. 2. Profitable small batch production: It allows for the economical production of small batches and individualised products. 3. Accelerated product time to market: Products can be brought to market faster due to

the efficiency and flexibility of adaptive systems. 4. Readiness for unknown future products: Adaptive manufacturing is designed to handle products that may not yet exist, ensuring future-proof operations. B&R’s adaptive manufacturing solution comprises of trackbased transport ACOPOStrak, SuperTrak and ACOPOS 6D that transport workpieces through a machine individually and without being bound to rigid timing. Machine vision cameras automatically detect the shape, size and orientation of each product and pass that information on to a robot in less than a millisecond. Aided by machine vision, robots pick up products and place them on a track system shuttle with lightning speed. Design, develop and diagnose without the cost and risk of hardware prototyping using a full array of any thirdparty simulation tools. These innovative mechatronic systems make it possible to manufacture small batches and individualised products economically and is helping manufacturers raise their OEE scores by at least 50 per cent.

EXPRESS PHARMA

January 2025

PHARMA PULSE

Inox - Repeating Syringe Dispenser Inox is a hand-held, semi-automated dispenser that offers repetitive accurate dispensing of 30μL - with a Calibration certificate

he Inox Repeating Syringe Dispenser is a low-cost, high-accuracy accessory for repetitive dispensing. Each press of the button dispenses 1/50th of the syringe volume. The precision fluid measuring device consistently dispenses samples up to 50 times.

Repetitive accurate dispensing of 30μL - with a Calibration certificate It is the most versatile, handheld, semi-automated dispenser available in the market today. The repeating dispenser is compatible with the fixed needle (LTFN), luer tip (LT), or PTFE Luer Lock (TLL) syringes. The size available is 1.5ml, which can dispense volumes of 30μL respectively with the “Inox” Repeating Syringe Dispenser. Every time you press the dispenser button, the Inox Repeating Dispenser mechanically advances the syringe plunger by 1.2mm. Based on a 60 mm scale

76 EXPRESS PHARMA January 2025

length at the full volume of the respective syringe, the 1/50th volume is accurately dispensed. Most fluids can be effectively handled using either a 22 gauge needle. You can use it with the Luer Tip (LT) and syringes to work with your specific needles. The Inox Repeating syringe dispenser has virtually unlimited applications when there is a need to deliver liquid volumes of 30μL repeatedly up to 50 times before refilling.

Features ◆ Wetting Material – PTFE,

glass and ss needle ◆ Inox Repeater Dispenser mechanically advances the syringe plunger by 1.2mm ◆ On a 60mm scale length at the full volume of the respective syringe, the 1/ 50th volume is accurately dispensed ◆ Autoclavable at 121°C for 20 minutes (CT& TLL only) ◆ Dosing Accuracy: Tolerance < 1 per cent of dose ◆ Calibration certificate with each syringe. ◆ 1.5ml syringe can dispense volumes of 30μL respectively.

Some typical uses include: ◆ Preparing standard solutions ◆ Filling microliter trays ◆ Feeding cell cultures ◆ Spotting TLC plates ◆ Human leukocyte locus-A (HLA) tissue typing ◆ Dosing small animals (Intracerebral) ◆ Industrial applications include lubricating small bearings or parts, applying liquid solder, and dispensing mercury Top Syringe exports its products to over 40 countries worldwide and counting, keep-

ing a single quality standard for local and export products. Repetitive Accurate Dispensing of 30μl The “Inox” - REPEATING SYRINGE DISPENSER is manufactured 100% in India by Top Syringe Mfg Co (P) Ltd. We are fully committed to supporting you with our full product range, spares, and technical assistance. Address - Top Syringe Compound,W.E. Highway, Pandurangwadi, Mira road (East), Thane 401107, India. Mob: 81046 82560 Email : sales@topsyringe.com website: www.topsyringe.com

PHARMA PULSE

Ensuring clean room integrity with Prime Clean Reset high-speed doors High-speed clean room doors offer a range of critical benefits essential for maintaining stringent environmental control. They enhance hygiene by providing an airtight seal that effectively isolates clean room environments, preventing the ingress of dust and other contaminants

igh-speed doors for clean rooms are specialised industrial doors essential for maintaining controlled environments. These doors are engineered to be airtight, creating a reliable barrier between different areas of a facility. Their design ensures durability and minimal maintenance, reducing the frequency of repairs and replacements. High-speed clean room doors offer a range of critical benefits essential for maintaining stringent environmental control. These doors enhance hygiene by providing an airtight seal that effectively isolates clean room environments, preventing the ingress of dust and other contaminants. This capability is especially crucial in sectors such as pharmaceuticals, biotechnology, and food production, where maintaining sterility is non-negotiable. In the pharmaceutical and life sciences industries, compliance with rigorous regulatory standards necessitates the manufacture of products within controlled clean room environments. A high-performance clean room door is an integral component in ensuring the integrity of these spaces, safeguarding product quality and patient safety. Beyond contamination control, these doors are engineered with advanced safety mechanisms, including automated sensors and emergency stop functions, which mitigate the risk of operational hazards. Moreover, high-speed clean room doors are designed to maintain precise overpressure or under pressure conditions within the environment. This is vital for preventing cross-contamination and ensuring that the clean room remains in a state of controlled integrity,

High-speed clean room doors are designed to maintain precise overpressure or under pressure conditions within the environment. This is vital for preventing cross-contamination and ensuring that the clean room remains in a state of controlled integrity, even under varying operational demands even under varying operational demands. Given the critical role these doors play in maintaining the purity and safety of highly specialised environments, selecting the appropriate door system is a decision of strategic importance. Prime Clean Reset, our high-speed door is designed specifically for clean rooms.

This innovative solution is engineered to meet the stringent requirements of controlled environments, ensuring exceptional performance and reliability. Designed with precision to meet the stringent requirements of controlled environments, Prime Clean Reset is the epitome of performance and reliability, ensuring that your clean room operations consistently meet the

highest standards of regulatory compliance and product integrity. Prime Clean Reset is suitable for clean rooms up to ISO Class 5, offering an unparalleled air permeability rate of less than 12 m³/m² h at ? 50 Pa. This ensures that even in the most sensitive environments, the door effectively maintains the critical pressure differentials required to prevent contamination, thereby safeguarding your processes and products. Engineered with cuttingedge European technology and innovative design principles, Prime Clean Reset offers rapid cycle times for both opening and closing, making it the optimal solution for medium to large entrances in clean room applications. The door's construction is specifically tailored to minimize air leakage and particulate infiltration, ensuring that it supports the rigorous cleanliness standards necessary for applications such as pharmaceutical manufacturing, semiconductor fabrication, food processing, and other highly specialised sectors. With its robust design and reliable performance, Prime Clean Reset seamlessly integrates into your clean room infrastructure, providing a critical barrier that preserves the integrity of controlled environments. Whether you are operating in a pharmaceutical, biotechnology, electronics, or defence industry, Prime Clean Reset offers the precision, durability, and compliance needed to maintain your competitive edge in highly regulated markets. Key features of Gandhi Automations' High-Speed Clean Room Doors include: ◆ Low air permeability: Designed to maintain low air permeability in pressurised rooms

with both positive and negative air pressure. ◆ Compact design: The doors are designed to fit inside the columns, with a self-supporting construction that minimises air leakage. ◆ Customisable transparency: They can be equipped with transparent PVC horizontal sections or vision windows for visibility. ◆ Specialised side guides: The special side guides ensure a tight integration of the curtain, providing high leak tightness. ◆ Efficient operation: The doors offer high efficiency and low permeability values, compliant with EN 12426 and EN 12427 standards, ensuring < 12 m³/m² h ? 50 PA. ◆ Durable control device enclosure: The control device enclosure is made of StainlessSteel SS 316, ensuring durability and resistance to corrosion. These high-speed doors are meticulously engineered to minimize air leakage and maintain strict environmental control, making them indispensable for clean room operations. Their rapid opening and closing operation ensure that the internal facility remains isolated from external conditions, effectively upholding the cleanliness and controlled environment essential for maintaining the integrity of clean rooms. For further information on high-speed doors offering, contact: Gandhi Automations Pvt Ltd Chawda Commercial Centre Link Road, Malad (W), Mumbai-400064, India. Off : +91 22 66720200 / 66720300 (200 lines) Fax : +91 22 66720201 Email: sales@geapl.com Website : www.geapl.com

EXPRESS PHARMA

January 2025

PHARMA PULSE

New testo 174 Mini Dataloggers: Revolutionising indoor climate monitoring The new testo 174 mini data loggers come in multiple models: testo 174 H BT, testo 174 T BT, testo 174 H, and testo 174 T. These loggers support Bluetooth and USB-C connectivity, providing seamless integration with mobile devices or PC software for easy data access and management

esto, a leader in measurement technology, introduces the new testo 174 BT (BT is Bluetooth enabled) series mini data loggers, designed to optimise indoor climate monitoring and ensure precise temperature and humidity control. The range offers smart, intuitive features that save time, reduce costs and provide hassle-free digital documentation for a wide range of industries, including food production, pharmaceuticals, and industrial sectors.

Innovative features for enhanced efficiency The new testo 174 mini data loggers come in multiple models: testo 174 H BT, testo 174 T BT, testo 174 H, and testo 174 T. These loggers support Bluetooth and USB-C connectivity, providing seamless integration with mobile devices or PC software for easy data access and management. These loggers are designed to meet stringent quality assurance requirements and simplify compliance with regulatory standards.

Bluetooth-enabled data loggers: convenient and efficient The testo 174 H BT (for temperature and humidity) and testo 174 T BT (temperature only) are equipped with Bluetooth, allowing for convenient wireless monitoring. Users can easily configure, record and evaluate measurement data using the free Testo Smart App. The app connects directly to the loggers from up to 30 meters away, enabling real-time data retrieval without the need to remove the device from its monitoring location. This wireless functionality ensures more efficient operations and signifi-

78 EXPRESS PHARMA January 2025

cant time savings. With automatic data backup, even if the battery is replaced, all previously recorded data remains intact. The Testo Smart App allows for seamless excel exports, as well as the generation of professional PDF reports with signature and comment functionality. These features eliminate the need for manual recordkeeping, reducing the risk of human error and ensuring paperless documentation. Both Bluetooth models are HACCP certified, ensuring they meet food safety standards, and the testo 174 T BT also holds NSF certification and complies with EN 12830, making them ideal for indus-

tries that require stringent monitoring, such as food production and pharmaceuticals.

these devices can operate for extended periods, ensuring continuous monitoring. The data can be easily accessed and analysed using the ComSoft Basic software, included with the devices, for fast configuration and readout. ComSoft Professional offers advanced features for batch programming, data analysis, and report generation, making it easier to handle complex quality assurance tasks. Like the Bluetooth models, these USB-C loggers also meet HACCP standards and EN 12830 requirements and the testo 174 T is NSF certified, ensuring reliable product safety in sensitive industries.

USB-C data loggers: Simplified data acquisition

Why choose testo 174 Mini Data Loggers?

For users who prefer traditional PC-based data management, the testo 174 H (temperature and humidity) and testo 174 T (temperature only) models with USB-C offer an intuitive solution. These loggers feature a large measurement range, from -30 °C to +70 °C for the Testo 174 T and -20 °C to +70 °C for the Testo 174 H, ensuring precise readings for a wide variety of applications. With a data storage capacity of up to 16,000 readings,

◆ Time and cost efficiency: Digital documentation and easy data retrieval reduce manual labour and the risk of human error, saving time and costs. ◆ Wireless connectivity: Bluetooth-enabled models offer convenient data readout via the Testo Smart App, streamlining processes. ◆ Large data storage: With up to 16,000 readings, these loggers support extended measurement periods without the

need for constant monitoring. ◆ HACCP and NSF certification: Compliance with international standards ensures reliable product safety in food, pharmaceutical and industrial environments. ◆ User-friendly software: The free Testo Smart App and ComSoft software make data management simple and efficient. Whether you're ensuring the quality of temperature-sensitive goods or maintaining optimal indoor climates, the testo 174 series mini data loggers provide a reliable, efficient, and intuitive solution for all your measurement needs.

Service and calibration Located at its Head Office in Pune, Testo India has a high quality NABL accredited service and calibration lab. Instruments of any brand/make can be calibrated and serviced locally maintaining international standards. All calibrations are traceable to highly accurate international standards of the PTB Germany. They undertake calibration jobs for temperature: contact as well as non-contact, humidity, pressure, air velocity, RPM, sound, flue gas and dew point instruments of any brand/make.

Testo India Testo India Pvt. Ltd. is a 100 per cent subsidiary of Testo SE & Co. KGaA (headquartered in Titisee, Germany) which was established in 2006 and has shown phenomenal growth over the last 18 years with its head office in Pune, and a PAN India network. For more info: Write to info@testo.in or visit www.testo.com

REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2025 – 27, PUBLISHED ON 5TH EVERY MONTH, POSTED ON 9TH, 10TH, AND 11TH EVERY MONTH POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001