Express Pharma (Vol. 19, No. 3) February 2024

VOL. 19 NO. 3 PAGES 64

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2024: Healthcare and Life Sciences Investment Outlook

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PPL 2024: Championing innovation, powering progress

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CONTENTS

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

Pg18

Lakshmipriya Nair Kalyani Sharma DESIGN Art Director Pravin Temble Senior Designer Rekha Bisht

MARKET

Senior Artist

IT@PHARMA

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Rakesh Sharma Marketing Team

LIFE SCIENCES AND GEN AI

Ashish Rampure

26

Debnarayan Dutta Production Co-ordinator Dhananjay Nidre Scheduling & Coordination

CIRCULATION Mohan Varadkar

27

EVENT

Rajesh Bhatkal

Pushkar Waralikar

STRATEGY

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PPL 2024: CHAMPIONING INNOVATION, POWERING PROGRESS

2024: HEALTHCARE AND LIFE SCIENCES INVESTMENT OUTLOOK

REVOLUTIONISING OUTCOMES: AGILE CROS LEAD THE WAY

HR

28

HOW FLEXIBILITY FUELS INNOVATION IN INDIA’S PHARMA AND HEALTHCARE

PHARMA TECHNOLOGY

29

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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.

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EXPRESS PHARMA

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February 2024

EDITOR’S NOTE

Decoding the skirmish over revised Schedule M

R

ecent regulatory changes have underlined the fissure between the large and midMSME segments of the pharma sector.

The most recent evidence of this fissure is the representations of the pharma MSME sector to the Prime Minister's Office (PMO) and to state governments to defer the implementation of the Revised Schedule M of the Drugs Act 1940 that was amended by the Ministry of Health & Family Welfare vide Notification GSR 922 (E) dated December 28 last year.

On January 25, the SME Pharma Industries Confederation (SPIC) wrote to the Prime Minister reasoning that the new Schedule M and price control are incompatible, as they will lead to shortages of drugs on the National List of Essential Medicines (NLEM).

The association also predicts that supply of medicines to Pradhan Mantri Jan Aushadhi Kendras (PMJK) would also dry up in a year’s time, as less than 20 per cent MSEs would survive after implementation of the Revised Schedule M. The remaining 20 per cent would be unable to produce medicines for PMJK or most of the NLEM medicines because the production cost post implementation of the Revised Schedule M would be higher than the permitted MRPs. The SPIC letter claims that 80-90 per cent MSEs have a turnover of below Rs.10 crore, as they are not based in states which enjoyed tax holidays from 2003 to 2017. These companies did not have the 30 per cent advantage of their counterparts in tax holiday states and are therefore nowhere near the Rs.250 crore slab mentioned in the Notification. The letter alleges that such turnovers are prevalent in only 2000 units in the erstwhile tax holiday states for whom the Notification is appropriate.

As per the SPIC letter, the recent risk based joint inspections also proved that 90 per cent of pharma units do not comply with the previous Schedule M,and therefore questioned its upgradation. The conclusion is that the ‘amendment is motivated by Big Pharma and vested interests - who claimed to be leaders of MSMEs. Their real motive is profiteering by closing down MSMEs to create pre 1960 conditions when prices of medicines was highest in India and shortages were common.’

The letter concludes, that if affordable medicines especially for the poor have some significance in the country, pharma MSMEs and their capacity to produce affordable drugs needs to be preserved and hence the New Schedule M should be kept in abeyance for MSEs having less than Rs.10 crore turnover outside the erstwhile tax holiday states.

Earlier, The Tamil Nadu Pharmaceutical Manufacturers Association (TN PMA), representing 150-odd micro and small drug manufacturing companies of that state, had made a similar request in a letter to the Union Health Minister and to the Drug Controller

10 EXPRESS PHARMA February 2024

Both, large and mid/small size pharma companies, are vital parts of India’s pharma sector, one serving export markets, the other serving the domestic markets with affordable quality medicines. The government will need to engage with and incentivise both, especially in an election year, to bridge the widening divide between them

General of India (DCGI).

Acknowledging the need to upgrade to global MGP standards, the TN PMA asked for three years to implement the Revised Schedule M. They then approached the state government to take up their concerns with the central government about adoption of the Revised Schedule M. A Punjab-based pharma Special Purpose Vehicle (SPV) Pundrug Research Foundation, comprising 10 pharma companies in Punjab, has also petitioned the PMO that if the government does not extend the timeline for pharma companies to comply with the Revised Schedule M, there may be multiple closures, leading to the shut down of their common facility due to lack of users.

In the representation to the PMO dated January 9, 2024, Jagdeep Singh, Chairman, Pundrug Research Foundation pointed out that if the Revised Schedule M Notification is implemented within one year as stipulated, it would wipe out more than 130 units out of 140 units in Punjab simply because units in Punjab bore the brunt of tax holiday in the neighbouring hill states for 14 years from 2003 to 2017. Therefore he stated that the promoters of the SPV are unwilling to proceed (to deploy the grants received) ‘unless the timelines for implementation are spread between 5-10 years for units outside the erstwhile Tax Holiday States which includes Punjab.’

These representations underline the widening divide between the large and mid/small size pharma companies. In fact, these associations are predicting that the implementation of the revised Schedule M could spur shut downs, consolidations and mergers among the MSME pharma sector. Both sides are vital parts of India’s pharma sector, one serving export markets, the other serving the domestic markets with affordable quality medicines. As we wait for the Interim Budget 2024-25 budget, it is not likely that Finance Minister Nirmala Seetharama will make any big changes in the last budget before the Narendra Modi government readies itself for elections later this year. More incentives for R&D and local manufacturing as well as simplifying compliances to improve ease of doing business sums up the basic pre-budget wish list for the pharma sector. In addition, the government will need to engage with and incentivise both large and MSME pharma companies, especially in an election year. While the temptation would be to merely placate the sector and then ignore it, we only need to look back two-three years, to the start of the COVID pandemic, to convince us that a healthy pharma sector is necessary for a healthy population.

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

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2024: Healthcare and Life Sciences Investment Outlook Kapil Khandelwal, Managing Partner of El-Toro Finserve LLP highlights factors influencing the industry, including geopolitical considerations, emerging trends, and specific outlooks for various sub-sectors within healthcare and life sciences

I

n 2024, the world will be as uncertain, if not more, as it was and anticipating what will happen next is an ever more challenging task for our algorithms and our teams. Since 2013, our algorithms have been accurately predicting the investment heatmap in the healthcare and life sciences in India with 95 per cent accuracy on the sectoral investment cycle in India till the end of 2019. Since the Covid pandemic in 2020 we lowered levels of prediction accuracy like we started back in 2013.

The fake narratives and echo chambers that were peddled during the pandemic years of 2020-22 vitiated our predictions during the pandemic years. 2023 was even more unpredictable in many ways. Our algos do not penetrate the terrorists, government intelligence and security networks and hence are unable to consider events that play out in the Middle East, impacting geopolitics, investments in Indian healthcare and life sciences since some part of the investment flows from offshore.

Hence, we have made attempts to analyse international ‘geo politics’ as a separate factor and bolt-on-top of our algo predictive models to adjust our heat map for 2024. This would accurately predict whether the heat is on in our 2024 Heat Map.

2024: A year of geopolitics than geo economics The biggest political event in India in 2024 will be the Lok Sabha General Elections. Hence H1 2024 will not see any major policy or budgetary directions to the sector till the new government takes over in New Delhi by June 2024 and presents its budget. For the first time, in the post pandemic era, almost all global funds, analysts and bankers have a unanimous consensus on India’s positive outlook for 2024, some even covering India as a separate chapter in their reports which was dedi-

14 EXPRESS PHARMA February 2024

and its returns will tend to outperform the market, as yields decline. ◆ As new Generative AI capabilities emerge, the investments in human capital for newer skills are emerging. Also, newer models of ‘sweat’ equity/debt are emerging. ◆ Investments in newer health and wellness solutions to weather climate change are getting exciting. ◆ M&A and buyouts are expected to continue, but lower from the peak of 2022. ◆ How India plays its geopolitics will also determine the quality and quantum of foreign investments in India in the various sub sectors.

Healthcare financing cated to China in their Asia Outlook till 2022. However, healthcare and life sciences sub sectors in India have its divergence to the overall India outlook for 2024. We have endeavored to bring out the deeper analysis and specifics out of the broad ‘India Positive’ Outlook for 2024 for the healthcare and life sciences sector in India.

The wave of optimism for 2024 in Indian healthcare and life sciences stems from the following: ◆ The pace of digitisation is now veering toward mainstream adoption of Generative Artificial Intelligence (AI) tools and solutions across that are being piloted. ◆ New business models/incubation for investments are emerging that will be cross-domain ◆ The bills and laws introduced in the Parliament are yet to shape bounce in investments. ◆ Muted returns in the private markets will continue in 2024 as the winter of private investments continues in 2024. Let us understand that the best investments tend to occur during times when investment outlooks

appear riskier, so the lower prices in many kinds of equity investments might well yield attractive returns over time. ◆ Companies listed on the bourses have always underperformed the broader index in the last two general elections of 2014 and 2019 by -4.5 to -6.5 per cent.

We are expecting the elections results to be neutral this time on the Indian bourses. A few big names to IPO in 2024. ◆ With one-third of India’s population now constituting Gen Alpha and Gen Z, the health and wellness aspirations of this cohort is the growing aspirational class that wants to live life post Covid-19 differently and different products and services will serve as the next growth opportunity. ◆ The valuations have come back to realistic levels to the preCovid levels for primary and secondary investments. ◆ Debt and equity requirements have stabilised as the cashcrunch situation during the pandemic have ‘normalised’ and so are the return expectations.

Both are negatively correlated with yields globally. In other words, investments in equity

Newer products for financing healthy lifestyle for the Gen Alpha and Gen Z are emerging.

Financing ‘idleness’ and healthy entertainment lifestyle through innovative business models are the key. There is a consumer shift for spending on healthy lifestyle which is a personal investment in longevity of healthy life. ◆ 2024 Outlook: Moderate ◆ What’s going wrong: slower market/product innovation, right bite for the consumers, reach and penetration to New Gen consumers, financing costs ◆ What’s going right: India stack digitisation, uberisation, AI solutions

Medical education Valuations are correcting and consolidation activity is accelerating. New regulatory regime will come into force and will require investments in managing the delivery and quality of content. New skills for the new AI tools and newer consumer’s requirements are accelerating but not in the curriculum. ◆ Outlook: Moderate ◆ What’s going wrong: Alignment to new consumers and care, increasing debt burden,

new age skills certification, CME with AI-tools ◆ What’s going right: Skill-mix churn, upgradation of skills, AI for frontline workers

Med tech innovation and life sciences discovery and clinical development Capacity creation and new product development continues as India is now into the China+1 club. Expect a few IPOs this year in this sector. Government grant funding will temper down. Geo polities is a key risk to create supply chain disruptions. ◆ 2024 Outlook: Hot ◆ What’s going wrong: IP regulation, regulatory bottlenecks on clinical development, newer skill sets for research and acceleration, PLI policy for sub sector, geo politics, supply chain disruptions ◆ What’s going right: Human capital, emerging social innovation models, right products selection, market appropriate solution development, peptide based products, chronic diseases product innovation for co morbidities

Pharma and therapeutic solutions Geo politics may affect supply chain and missed topline and profitability estimates. Cost competitiveness like Chinese players to compete globally is the key for growth. Expect a few IPOs, buyouts and exits via secondary sale. ◆ 2024 Outlook: Moderate ◆ What’s going wrong: price controls, wrong product portfolio, capacity scale up, global or China-level cost competitiveness, exit of PLI incentives, shortage of skilled workforce ◆ What’s going right: distribution infrastructure, digital business models, government incentive programs

Healthcare providers High levels of leverage is still a

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MARKET concern. Private equity investments are slowing down due to valuation expectations. Expect a few IPOs, buyouts and exits via secondary sale. Capacity creation is slowed down due to fund crunch. ◆ 2024 Outlook: Moderate ◆ What’s going wrong: margin pressures, price controls, execution of programs on the ground, supply and demand mismatch in micromarkets, debt financing costs, gun powder churn, operating cash runway, liquidity and working capital crunch, not exploring newer formats ◆ What’s going right: asset-lite models, medical tourism

Healthcare insurance Loss ratios and profitability is

slowing improving as pricing and products are rationalized.

Expect two IPOs of two major players. New products innovation for newer consumer’s requirements is lagging. ◆ 2024 Outlook: Hot ◆ What’s going wrong: product fit to consumer needs, product approvals, IPOs pricing and valuation ◆ What’s going right: Consumer demand, reduced loss ratios

fund and buy-outs, secondary exits. Expect an IPO. ◆ 2024 Outlook: Hot ◆ What’s going wrong: regulation, operating margins, spurious social media channels affecting consumer confidence, health UPI, time to scale ◆ What’s going right: consolidation, newer cross-vertical innovative business models, profitability focus, AI adoption and models

Wellness Health retail The Pharmacy Bill 2023 brings its own set of challenges. AI pilots once mainstream will reduce costs and margin pressure albeit very slowly. The valuation is still a challenge for raising

2021 was the highest growth year in the last 10 years on the back of discretionary consumer spending on wellness. Digital business model innovation is still lagging. Corporate Wellness spends to continue to fuel

The 2024 India Healthcare and Life Sciences Investment Heat Map

16 EXPRESS PHARMA February 2024

growth. ◆ 2024 Outlook: Very Hot ◆ What’s going wrong: regulation, maturity to scale, new mass market business models, repeat sales, spurious social media channels, fake outcome/ claims ◆ What’s going right: newer cross-vertical innovative business models, corporate wellness spending

search, new product development, inflated valuation, new mass market business models, repeat sales, spurious social media channels, fake outcome/ claims ◆ What’s going right: discretionary consumer spending, newer cross-vertical innovative business models, mainstream complementary treatment

Alternative therapies

Moving forward

New Gen consumers are seeking unique experiences. Their discretionary spends on mental health and rejuvenation are increasing. ◆ 2024 Outlook: Very Hot ◆ What’s going wrong: maturity to scale, consumer education and confidence, clinical re-

As one iconic smart investor said one should be investing in healthcare and life sciences because you believe smart investing will yield results that are beneficial for society, not just to enrich oneself.

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cover )

Pharma companies in India should advantageously position themselves with strategic investments and collaborations to harness the immense potential of cell and gene therapies

By Lakshmipriya Nair

18 EXPRESS PHARMA February 2024

EXPRESS PHARMA

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February 2024

cover ) T

he global cell and gene therapy market is expected to reach $80 billion in 2029, with a high CAGR of 51.6 per cent between 2023 and 2029, according to GlobalData. In its recent survey, healthcare industry professionals scored cell and gene therapy (C&GT) as the industry trend to have the greatest impact on the pharma industry in 2024. Oncology is expected to continue its lead as the indication and area of major development for cell and gene therapies, accounting for 44 per cent of the CGT market by 2029.

Urte Jakimaviciute, Senior Director of Market Research at GlobalData, informs, “Cell and gene therapies are gradually becoming more important focus areas within the healthcare industry and their full potential is still unrealised. While this is a relatively new area, with the first autologous dendritic cell therapy Provenge approved in 2010 for prostate cancer, these therapies promise life-changing treatments for a broad spectrum of complex diseases ranging from genetic conditions to cancers.”

Giving a more detailed view, Dr Senthil Sockalingam, Head, IQVIA Biotech in Japan-Asia Pacific; Chief Medical Officer, IQVIA Asia Pacific outlines in his article, ‘Biotech and Biopharma Industry Trends: What to Watch for in 2024’, published in Express Pharma’s issue in January 2024, “We are seeing the expansion of chimeric antigen receptor (CAR) T-cell therapy beyond its initial application to treat hematological malignancies such as myeloma, acute lymphoblastic leukemia and non-Hodgkin’s lymphoma, and into orthopedics, organ transplantation, and neurology. The world’s first CRISPR gene-editing therapy was approved in November 2023 in the UK for sickle cell disease and transfusion-dependent ß-thalassemia.

This approval is a significant landmark for the biotech industry, potentially setting the stage for a new generation of

20 EXPRESS PHARMA February 2024

Source: OPPI - EY report: Reimagining pharma and healthcare for India@100

gene-editing therapies to be approved for conditions that were previously considered untreatable, as well as injecting a timely boost into the gene editing R&D universe.

CRISPR-based therapies face similar challenges as CAR-T in terms of cost and the substantial healthcare infrastructure needed for treatment administration, and therefore, 2024 holds potential for innovation beyond the treatment itself.

This spells good news for India Pharma Inc. Why? Let’s take a look.

The India advantage The pharma industry in India has a rich history of generic drug manufacturing and export. In recent years, the industry is undergoing a shift through adoption of cuttingedge technologies towards development of innovative therapies such as cell and gene therapies (C&GT). As a result, there is burgeoning growth of cell and gene therapies in India. While the sector is still in its early stages, it has gained significant momentum in recent times.

A report released last year

by OPPI and EY, ‘Reimagining pharma and healthcare for India@100’, informs, “During the span of last six years (20152021), cell and gene therapies (C&GT) and DNA/ RNA therapies have seen a growth of 30 per cent and 46 per cent, respectively.”

This growth is underpinned by several factors such as: ◆ Cost benefit: There is an urgent need for affordability in advanced therapeutics to democratise healthcare and it presents a huge opportunity for India. As the OPPI and EY report outlines, “This is a big step ahead for India in the right direction. The need is now to increase the overall pace and scale of innovation.

Most new modalities are available at very high prices globally. The increasing pricing pressures and new pricing regulations are coming up across all regions. With its dual strength of ‘quality with

EXPRESS PHARMA

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February 2024

affordability’, India has the potential to become the next bright spot in the ‘next generation therapeutics space’, and potentially emerge as a frontrunner similar to how it

became the generics leader of the world.” ◆ Focus on rare and genetic diseases: India has a high burden of rare and genetic diseases. These unmet needs

can be met by developing affordable and accessible C&GTs. Moreover, the growing focus on precision medicine is also spurring growth in this segment. Indian pharma com-

panies can leverage their expertise to develop personalised C&GT solutions. ◆ Government support: Initiatives like the Biotechnology Industry Research

cover ) Assistance Council (BIRAC) and Startup India provide funding and incubation support to promising C&GT startups. The Indian government is also streamlining the regulatory pathway for C&GTs, making it easier to conduct clinical trials and gain faster approvals in the country. For instance, the guidelines tailored for gene therapy products were released in 2020. In Oct 2023, the Central Drugs Standard Control Organisation (CDSCO) approved ImmunoACT’s CAR-T cell therapy, NexCAR19 which was indigenously developed in India. ◆ Evolving clinical trial landscape: As an established global CRO hub, India has significant expertise in clinical trials and regulatory affairs, crucial for C&GT development. Likewise, India's vast population offers a rich pool for clinical trials, providing valuable data for global C&GT development. Increased investments in research facilities and skilled personnel are further strengthening India's clinical trial capabilities.

Dr Sockalingam informs, “While India is well-established as a global powerhouse for generic medicines, there has been a gradual shift in R&D activities to other strategic areas such as biosimilars, complex generics, and new chemical and biological entities. The maturation of India’s regulatory environment coupled with vast patient populations and lower research costs makes India an attractive proposition for clinical research. This not only enables broader access to novel therapeutic innovations for Indian patients but also creates increased commercialisation opportunities in what is now the world’s most populous nation.”

Mounting investments With the rising interest in cell and gene therapies, there is a surge in investment and collaboration opportunities.

Indian pharma companies are increasingly partnering with global biotech firms and

22 EXPRESS PHARMA February 2024

INVESTMENTS AND PARTNERSHIPS (2021- PRESENT) ◆

In Jan 2024, Natco Pharma acquired a 5.38 per cent stake in Cellogen Therapeutics. Reportedly, Natco Pharma is investing over $2 million in this company to develop bi-specific CAR-T cell therapies for cancer

◆

Laurus Labs invested Rs 80 crore in ImmunoACT, a cell and gene therapy company developing personalised therapies for cancer and metabolic diseases in August 2023. It is also establishing a facility specifically for manufacturing cell and gene therapy products. In Oct 2023, the CDSCO approved India’s first indigenously developed CAR-T cell therapy, NexCAR19, developed by ImmunoACT

◆

Immuneel Therapeutics, headquartered in Bengaluru, is awaiting regulatory approval for their CAR-T cell therapy named Varnimcabtagene in India, post encouraging initial findings emerging from the IMAGINE study

◆

In 2022, a consortium including three major Indian pharma companies – Alkem Laboratories, NATCO, and Biological E invested in Eyestem Research, a cell therapy company with a vision to develop a scalable cell therapy platform to treat incurable diseases

◆

Dr Reddy's Laboratories secured exclusive rights to market Shenzhen Pregene Biopharma’s anti-BCMA CAR-T cell therapy in India in 2021

development and approval process for these innovative therapies. Likewise, industry stakeholders will have to build robust manufacturing infrastructure as well as attract and retain skilled professionals in this segment to ensure pace and sustainability of progress.

Investments in these key areas are essential to meet the stringent quality and safety standards mandated for these advanced therapies.

At the same time, leveraging emerging technologies is also crucial. Industry experts and analysts also acknowledge this. The OPPI-EY report emphasises, “Digital technology, data analytics, and Artificial Intelligence (AI)/Machine Learning (ML) hold the potential to revolutionise the entire R&D value chain, spanning

Source: OPPI - EY report: Reimagining pharma and healthcare for India@100

research institutions to access cutting-edge technologies and expertise, thereby enhancing their capabilities in this field.

Several biotech start-ups in India are also focusing on innovative C&GT solutions for local and global markets. And, many of them are entering into collaborations and partnerships with Indian and global pharma companies for clinical development, manufacturing, and commercialisation, creating a win-win situation. See Box 1

Challenges to conquer While the trajectory for growth in this segment looks

promising and exciting, several challenges loom on the horizon. GlobalData anticipates that while cell and gene therapies are set to become an established treatment modality in the years to come, higher development and production costs, the risk of clinical trial failures, and intensifying pricing and reimbursement pressures will continue to place further stress on these innovations.

Similarly, the OPPI-EY report states, “While novel drug development promises high returns, it also requires a high investment of time and

resources. In the OPPI-EY CXO survey, the need for substantial investments over an extended gestation period, coupled with high risk of failure, emerged as the foremost barriers impeding the industry's advancement in the realm of innovation.”

It adds that government incentives, tough intellectual property protection, and a flourishing domestic market for novel drugs were accentuated as crucial aspects to success and growth.

Thus, India’s regulators and policy makers need to further refine and streamline the

from drug discovery to clinical development. This transformation can enhance efficiency and productivity, reduce costs and timelines, and improve patient access and diversity.

Globally, numerous start-ups are emerging to offer R&D platforms and solutions, some of which have already achieved initial success. Given India's robust IT capabilities, the country has a substantial opportunity not only to lead in this domain, but also to catalyse the innovation journey of the Indian pharma industry.”

Another area of importance is developing pricing models

that will enhance access and affordability of cell and gene therapies. Making these therapies accessible to a broader population without compromising quality and efficacy is crucial.

Going ahead The business potential of cell and gene therapies in the Indian pharma industry is significant. As the country positions itself as a hub for innovation, strategic investments, regulatory support and collaborative efforts will be pivotal in unlocking the full potential of cell and gene therapies. Proactive measures by industry players, regulatory bodies and academic institutions will pave the way for progress in this field. lakshmipriya.nair@expressindia.com laxmipriyanair@gmail.com

Source: OPPI - EY report: Reimagining pharma and healthcare for India@100

EXPRESS PHARMA

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February 2024

IT@PHARMA

Life sciences and Gen AI Gen AI will have a very high impact on the healthcare and life sciences value chain, with the potential to benefit every aspect — from clinical services to customer operations, finds EY Report titled 'The AIdea of India: Generative AI’s potential to accelerate India’s digital transformation'. It highlights that Gen AI applications are contributing to the life sciences sector in many ways, including drug development, highly targeted therapies, supply and demand planning, and operational efficiency improvement

Excerpts from the report

G

lobally, AI has ushered in a transformative era for the healthcare and life sciences sector. It holds the potential for catalysing drug discovery, aiding clinical trials, enabling precision medicine, and streamlining healthcare operations. AI-powered algorithms can adeptly analyse vast datasets, identify potential drug candidates and curtail development timelines and costs.

Personalised treatment recommendations, rooted in patient data, have markedly enriched healthcare outcomes.

The healthcare and life sciences sectors have been relatively conservative in adopting digital technologies. Gen AI may change that with its ability to reduce the demand-supply imbalance caused by acute

shortage of clinical and nonclinical talent in the Indian healthcare system. Almost 60 per cent of our survey respondents from the healthcare and life sciences sector believe that Gen AI will have a very high impact on the entire value chain, making it more efficient and responsive to market dynamics.

In healthcare, Gen AI holds the promise of benefiting every facet of the value chain, from clinical services to customer operations and branding.

Similarly, in life sciences, the potential of Gen AI applications have to become too compelling to disregard. It is poised to expedite the assimilation of cutting-edge technologies across the value chain.

The transformative impact of AI on the life sciences sector

Sector-wise impact of Gen AI on GVA (2029-30)

Impact on sectoral GVA (X-axis) and additional GVA due to Gen AI (Y-axis) depicted here reflects the mid-point of the range-bound impact for each sector

The agenda for enterprises

Reimagining digital-AI first

Rebuilding the Tech Stack

Equipping the AI workforce

Shielding with Responsible AI

Enable new business models, customer journeys, products and services

Rebuild the tech stack–apps, data, infrastructure

Empower employees with the skills for the coming change

Put in place new governance–AI policies, data privacy, responsible approaches

24 EXPRESS PHARMA February 2024

Gen AI: Illustrative use cases from clinical services to customer operations and branding Clinical Services and Operations

Branding and Community Outreach

Customer Service and Experience

Non-Clinical Operations

Audit and Compliance

Clinical Documentation and Decision Support

Targeted Marketing and Branding

Digital Frontdoor for Self-Service

Insurance: Billing and Query Resolution

Identification of Compliance Gaps

Personalized Care Plans Patient Monitoring and Outcome Prediction is large, ranging from catalysing drug discovery, clinical trials, and enabling precision medicine to streamlining healthcare operations. AIpowered algorithms’ ability to analyse vast datasets and identify potential drug candidates is dramatically curtailing development timelines and costs.

Global pharma companies including Pfizer, Sanofi and Merck KGaA are using Gen AI tools for lead identification and drug discovery. Merck, for instance, is harnessing Gen AI to revolutionise drug discovery

On-the-go content creation Personalized engagement

through its platform, ADDISON™. Meanwhile, Pfizer is leveraging Gen-AI-powered chatbots to deliver personalised messages to clinical trial participants. Novartis is creating personalised recruitment materials for clinical trials. Companies like Janssen and Merck are using Gen AI tools for drug designing. Data analysis and integration to identify patterns, potential biomarkers, using Gen AI to screen molecules that interact with target life sciences and Gen AI proteins, repurposing existing drugs and predict-

In-hospital engagement

HR Operations

Contact Centre Co-pilot

ing side effects are some applications where Gen AI can potentially assist R&D and drug discovery before moving to clinical trial stage.

Further, with Gen AI’s ability to quickly analyse and interpret vast amounts of data, protocol designers can predict the roadblocks in trial protocols from the beginning and enhance clinical trial efficiency. It is also likely to impact regulatory compliance procedures (by automating and simplifying risk assessment) and the audit and monitoring process.

Revenue Cycle Management

In India, Gen AI use cases and breakthroughs have been mostly patient centric and witnessed in or confined to customer growth. The expansion of biotech incubators and startups is expected to play a key role in driving the growth of the Indian biopharma industry and they are likely to be early adopters of AI and Gen AI tools.

While the Indian life sciences enterprises initially exercised caution regarding AI adoption and trailed other sectors, numerous Gen AI applica-

Preventive Flags Digital Forensics and Fraud Detection

tions are now contributing to drug development and highly targeted therapies, which is likely to put India in the global clinical trial map. There is a likely fast followership in Gen AI in process optimisation across value chains, such as supply and demand planning and operational efficiency improvement, to enhance the efficiency and productivity. Life sciences companies have to focus on creating co-pilots in many of the above areas and bring in necessary skills into new ways of working.

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February 2024

EVENT PRE EVENT

PPL2024: Championing innovation, powering progress PPL Conclave 2024 will be held on February 16-17, 2024 at Le Meridien, Hyderabad

P

ackaging and labellling in pharma has witnessed significant developments in response to evolving needs of the industry with an emphasis on safety, quality, sustainability and technological innovation.

Be it temperature-controlled packaging solutions to meet the exacting standards for biologics and vaccines, integration of drug delivery systems into packaging for better patient outcomes, enhanced patient engagement through interactive packaging, adoption of biodegradable options to minimise environmental impact, use of anti-counterfeiting technologies or colour-shifting inks, packaging and labelling done right are adding significant value to this industry.

As these trends continue to evolve, the future of pharma packaging and labelling holds exciting possibilities.

So, Pharma Packaging and Labelling (PPL) Conclave 2024 aims to identify and harness pivotal trends in the dynamic landscape of pharma packaging. The conference will bring together industry experts to discuss strategies to achieve a balance between innovation and cost, functionality and aesthetics, as well as utility and sustainability. It will provide a platform for leaders and veterans in the pharma packaging and labelling industry to collaboratively address new challenges and surpass the mounting expectations within the pharma sector.

Some topics to be covered ◆ Packaging design: Optimising user experience for patient

26 EXPRESS PHARMA February 2024

safety ◆ Packaging for high-value biopharmaceuticals and vaccines ◆ Supply chain resilience through intelligent packaging ◆ AI and automation: Revolutionising pharma packaging and labelling ◆ Enhancing track and trace capabilities in pharma packaging ◆ Pharma packaging regulations: Navigating compliance in a global landscape ◆ Smart labelling technologies in pharma packaging: Barcodes, RFID, colour-changing inks and more ◆ Circular economy in pharma packaging and labelling: A

moral and business imperative ◆ Branding and market differentiation with packaging and labelling

Pharma Packaging and Labelling (PPL) Conclave 2024 Organised by Express Pharma, PPL Conclave 2024 will be held on February 16-17, 2024 at Le Meridien, Hyderabad. With opportunities galore for exchange of knowledge and networking of ideas, PPL Conclave 2024 is 'the' platform for packaging leaders, experts and veterans to come together confer, converse, on the current and future trends in the indus-

try, their growth drivers and the challenges to tackle them as well as form meaningful alliances to fast-track progress in the pharma packaging industry.

For the 100+ leading pharma packaging professionals attending the event, the two-day event will give an opportunity to: ◆ Get updated on the advancements in India’s pharma packaging sector ◆ Demonstrate your pharma packaging capabilities ◆ Showcase your innovative packaging solutions ◆ Gain insights from thought leaders

of the pharma, biotech and packaging industries ◆ Acquire access to solution providers with cutting-edge packaging technologies ◆ Discuss on the role of packaging in gaining a competitive edge ◆ Network with the who's who of the pharma packaging industry Pharma Packaging and Labelling (PPL) Conclave 2024 is committed to staying ahead of the curve and future-proofing progress.

To know more and register, check out: https://ppl.expresspharma.in

STRATEGY

Revolutionising outcomes: Agile CROs lead the way Vivek Chopra, Partner, Vector Consulting Group, and Alka, Senior Consultant, Vector Consulting Group detail the evolving role of Indian CROs from research facilitators to valued partners and recommend strategies for CROs to enhance productivity, reduce errors, and improve csutomer satisfaction

C

linical trials attest to the safety and efficacy of pharmaceuticals. But, they're not cheap to conduct.

By 2020, out of the mammoth $200 billion pumped into pharma research, a whopping $48.4 billion went into clinical trials. Given the current trajectory, the figures could balloon to $68.9 billion by 2025 and approach $84.44 billion by 2030.

CROs: The torchbearers To strike a balance between quality and cost, global pharmaceutical giants have, since 2005, leaned towards Indian clinical research organisations (CROs), especially for generics. This was catalysed by India's alignment with the TRIPS Agreement. India's draw mainly lies in its lower overall costs, pool of expert scientists and large volunteer base. Consequently, India now anchors about 20 per cent of global trials.

However, the economic advantage once provided by India is waning due to escalating costs. Undeterred, Indian CROs are evolving, pivoting from being mere research facilitators to valued partners who promise global standards and swift study timelines.

Setting CROs apart: Excellence and speed It is well known that fasttracked generics pharma products garner market advantage.

Afterall, every subsequent generic launch chip away at the price. Therefore, while cost matters, pharma firms also measure CROs by their ability to deliver quality research results quickly.

CROs’ hurdles CROs envision impeccable services for their clientele. This encompasses quick feedback loops, expedited study design,

Vivek Chopra, Partner, Vector Consulting Group

overloaded, causing essential activities to be overshadowed and subsequent errors/rework when trying to rush.

4. Training gaps: With doctor’s limited available capacity and extensive training needs for support teams before the trials can begin, the coordination for training becomes difficult. As a result, the training regime often suffers, leading to errors during the trials.

5. QA stumbling blocks: In a highly regulated environment, all issues need to be reported and resolved. It becomes difficult for Quality assurance getting hamstrung by constant backlogs. This slow response

Alka, Senior Consultant, Vector Consulting Group

It is well known that fast-tracked generics pharma products garner market advantage. Afterall, every subsequent generic launch chip away at the price.

Therefore, while cost matters, pharma firms also measure CROs by their ability to deliver quality research results quickly swift regulatory nods, better volunteer access, and efficient study execution. But this ambition often meets roadblocks: 1. Initial proposal bottlenecks: Sometimes drafting a proposal to send to a client becomes a drawn-out affair, sometimes pushing clients to explore other CRO options.

2. Protocol designing hiccups: Once a client is onboarded, protocol design if rushed through and done without proper due diligence, can lead to errors. Further resulting in extended approval cycles to start study or poorly designed study to start with.

3. CRD's juggling act: Clinical Research Departments (CRD) often find themselves

mechanism further compounds issues 6. Report merging delays: After trials, coordinating for reports across departments becomes a herculean task, delaying the final report dispatch to patrons.

Diagnosis and remedies What is evident is that since CRD (especially PIs) contribution is needed for all the tasks from proposal to report, managing their time efficiently and productively is the key to breaking free from this vicious cycle.

Some decisive actions are required for this: 1. Redefine CRD tasks: Dedicated teams can spend quality time either taking care of feasi-

bility responses or in protocol preparation as required. This will ensure these tasks are done on time without interrupting current studies.

2. Implement work prioritisation: An agreement on priority and limiting number of tasks handled simultaneously can help CRD complete pressing reports fast without stretching themselves thin.

3. Streamline processes: Processes have to be set up to ensure that time available for nurses, phlebotomists, and PIs in between their regular rounds of current studies is optimally used to close open observations from previously concluded studies that need their inputs

4. Faster detection and resolution of error: Processes should enable to raise and resolve queries on current studies on ongoing basis, so as to reduce open issues post completion of study.

5. Adopt train the trainer approach: Decentralised protocol training in small groups can ensure better retention and application and reduces the challenge for sync Some new work practices also have to be adopted: 1. Align inter-departmental workflows: A shared priority framework can enhance interdepartmental cohesion and timely report completion.

2. Kick-off only post readiness: Ensure all prerequisites are ticked off before diving into tasks to minimise disruptions and waiting for information.

3. Shift from deadlines to task frequency: Daily monitoring can pre-empt issues, encouraging proactive solutions.

4. Boost transparency: The daily monitoring of individual tasks in a study can be enabled by a project management software system providing the expected time of completion (ETC) of all reports. This goes a long way in providing visibility and timely actions.

Conclusion Adopting these steps can amplify efficiency, potentially cutting down observations/deviations by 40-50 per cent and hastening report generation by 25-35 per cent post-trial. Such prowess not only facilitates CROs to handle more studies but also skyrockets client satisfaction levels. With cleaner processes, regulatory queries post-submission can also dwindle. CROs able to achieve this proficiency position themselves as indispensable allies to their pharma clients.

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February 2024

HR

How flexibility fuels innovation in India’s pharma and healthcare Yeshasvini Ramaswamy, Serial Entrepreneur & CEO, Great Place To Work India explores how embracing flexibility not only empowers healthcare professionals but also catalyses innovation, reshaping the future of patient care in the country

I

n the heart of India's pharma and healthcare landscape, a silent revolution is taking place—one fueled not only by groundbreaking medical advancements but also by a fundamental shift in how work is approached. The fusion of technology and flexible work models is shaping a new era in patient care, one where empowerment and innovation go hand in hand.

In a world where healthcare professionals navigate the delicate balance between tradition and progress, the adoption of flexible work arrangements emerges as a game-changer. Beyond the obvious benefits for individual employees, this shift is proving instrumental in driving innovation, ultimately enhancing patient outcomes and experiences.

The pulse of progress: General trends in flexible work models As per the India’s Best Workplaces™ in Pharmaceuticals, Healthcare, and Biotech 2023 report, the component of flexibility stands strong in comparison to other industry sectors. A remarkable 81 per cent of employees across all organisations in this industry enjoy workplace flexibility. This is a testament to the industry's adaptability, acknowledging the unique demands placed on healthcare professionals.

What stands out even more is the resounding belief shared by 82 per cent of employees that individuals daring to explore new and improved ways of doing things, irrespective of the outcome, are celebrated. This culture of embracing experimentation

28 EXPRESS PHARMA February 2024

speaks volumes about the industry's commitment to purpose driven growth and advancement.

Delving deeper, a notable 44 per cent of employees express a strong belief that they experience ample innovation opportunities within their workplace. This signifies a shift from the conventional norms of the traditional healthcare sector practices, indicating a proactive approach towards fostering creativity and originality.

Diagnosing success: Insights from workplace dynamics

As per the India’s Best Workplaces™ in Pharmaceuticals, Healthcare, and Biotech 2023 report, the component of flexibility stands strong in comparison to other industry sectors. A remarkable 81 per cent of employees across all organisations in this industry enjoy workplace flexibility. This is a testament to the industry's adaptability, acknowledging the unique demands placed on healthcare professionals

Beyond the surface, the data reveals profound correlations between flexible work models, employee satisfaction, and organisational success.

Firstly, companies that cultivate an environment where employees feel positive about taking time off boast a 10 per cent higher retention rate. In an industry where burnout is a constant concern, acknowledging and encouraging the need for personal time becomes a strategic move towards sustaining a dedicated and motivated workforce.

Secondly, the connection between innovation opportunities and positive organisational perception is undeniable.

Employees who encounter ample innovation opportunities at work showcase a remarkable 25 per cent higher positive perception regarding their organisation as a great workplace. This aligns with the understanding that a dynamic and creative work environment not only retains talent but also attracts new, forward-thinking professionals.

Prescribing a future: The leadership imperative As leaders within the pharma and healthcare sectors, it is imperative for organisations to recognise the symbiotic relationship between flexible work models and innovation.

Nurturing an environment that values experimentation and provides room for unconventional thinking is the key to establishing high trust sustainable workplace cultures that will only propel the industry forward.

Encourage a culture where failures are viewed not as setbacks but as steppingstones toward progress. Celebrate those who dare to challenge the status quo and reward ingenuity, fostering an atmosphere where every team member feels empowered to contribute their unique perspectives.

Invest in technology that facilitates seamless collaboration and communication, transcending physical boundaries. The ability to work flexibly shouldn't compromise efficiency; rather, it should enhance it.

In conclusion, as we navigate the intricate landscape of healthcare, let us embrace the transformative power of flexible work models. By doing so, we not only empower our caring hands but also catalyse a wave of innovation that will redefine the future of patient care in India.

The prescription for success lies in the hands of leaders committed to fostering a workplace where flexibility and innovation intertwine, creating a healthier, more resilient industry for generations to come.

PHARMA TECHNOLOGY

Case Study: Hemofarm optimises cleaning processes with quick-change parts and second identical die table An extensive product portfolio and frequent product changes coupled with diverse production requirements make quick and easy cleaning of its tablet presses a vital necessity for Hemofarm, the Serbian pharma manufacturer. The generics producer relies on Romaco Kilian’s simple-toclean machine design for this reason. Jan Clement, Sales Director, Romaco Kilian explains how Hemofarm has maximally reduced the cleaning-related downtime of two KTP 420X and KTP 590X high-speed presses at its headquarters in Vršac by using quick-change parts and additional, identical die tables

H

emofarm is market leader in the Serbian pharmaceutical sector and Serbia’s largest exporter of drugs. Since 2006, Hemofarm – which produces more than 6.6 billion tablets and capsules annually – has been a part of the German STADA Group, one of the biggest generic pharmaceutical firms in the world.

Based in Vršac, Serbia, Hemofarm manufactures both proprietary drugs and products for the STADA Group, many of them on two KTP 420X and 590X tablet presses from Romaco Kilian. The KTP 420X achieves a maximum output of 360,000 mono-layer tablets per hour. The KTP 590X, with a maximum hourly output of 511,200 tablets, was developed for fast changeover between mono- and bi-layer production as well as highspeed production of effervescent tablets.

The demands placed on the tablet presses could hardly be more diverse: all in all, more than 200 pharma products with very different formulations are manufactured in batch sizes from 100 to 2,200 kg. Compression forces from 5 to 80 kN are possible, and the ingredients can be either processed in the form of wet or dry granules or compressed directly. One or two product changes per week take place on the KTP 590X and about three or four on the KTP 420X, so that intensive cleaning of the

tablet processing areas and the product-contacted press parts is a must. On top of this, partial cleaning is carried out between batches of the same product.

Far fewer components than other presses Romaco Kilian’s modern tablet presses have far fewer components than conventional models in the compaction area, which is decisive for cleaning – a major advantage in everyday production. “The small number of product-contacted parts, the optimised hygiene concept and various special features like the patented closed punch bellows turn cleaning a KTP series

Hemofarm reduces cleaning time by using identical die tables, which are simply exchanged at the end of a batch

press into child’s play”, explains Ivan Djokic, production manager at the Hemofarm site in Vršac. “All interchangeable parts are lightweight and can be dismantled without tools, and they’re just as straightforward to insert again. That’s why our machine operators say it’s a pleasure working with the Kilian presses.” Even the fill shoe can be removed by a single person without any problem because the gearbox is located outside of the compaction area. Apart from the die table, all of the Kilian press’s interchangeable parts weigh less than 15 kg.

Compact, hermetically sealed compaction area Hemofarm is Serbia’s largest pharmaceutical company and part of the STADA Group

The Kilian KTP 420X and 590X presses are additionally char-

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PHARMA TECHNOLOGY acterised by strictly separated compaction and service areas, so that tablet dust is prevented from penetrating the machine cabinet. The compaction area is very small and reminiscent of a hermetically sealed, stainless steel cage. The surface to be cleaned has been reduced by about a third, resulting in significantly shorter cleaning times.

All presses in Kilian’s KTP series have a very small footprint owing to their compact design and small window areas, for example 1,080 x 1,115 mm for the KTP 420X or no more than 1,230 x 1,325 mm in the case of the KTP 590X. If the windows are opened, the KTP 420X measures a mere 2,303 x 2,268 mm and the KTP 590X 2,567 x 2,472 mm. Thanks to this economical use of space, energy consumption in the cleanroom is proportionally less, leading to sustainably lower running costs.

Interchangeable parts cleaned while working in batch mode

A single machine operator requires just 10 to 15 minutes to install the interchangeable parts and the die table

The KTP 590X high-speed press is in use at Hemofarm 24/7 and is completely retooled and cleaned once or twice a week

Hemofarm currently has eight Romaco Kilian tablet presses in total

The use of identical die tables helps optimise a tablet press’s OEE and TCO

The die tables are cleaned by removing the upper cam track together with the upper and lower punches, while the lower cam track remains in the compaction area. To prevent dust from getting into the machine’s “gray” area during cleaning, a blind cover is fitted after removing the die table. The punches, dies, and other interchangeable parts are cleaned in an industrial washing machine. The die table itself is manually cleaned at Hemofarm.

A single Hemofarm employee takes care of the complete product change cycle, in-

completed in approximately one hour.

The two sets of interchangeable parts used by Hemofarm for both tablet presses include the fill shoe, tablet scraper, upper punch cover, suction nozzles and cover between the pressure roller blocks. These parts are kept ready in a closed transfer trolley and are installed in the tablet press’s processing area in the event of a product change. The parts removed following the previous batch are cleaned while manufacturing the next batch.

Additional die table increases availability In order to further reduce downtime during product changes, Hemofarm uses a second identical die table for each of the two tablet presses in addition to the quick-change parts.

“People often underestimate the impact of an identical die table when it comes to optimising a tablet press’s OEE and TCO”, comments Gerd Heinen, the Area Sales Manager responsible for Hemofarm at Romaco Kilian. “By investing in identical die tables, Hemofarm is demonstrating a pioneering approach.”

30 EXPRESS PHARMA February 2024

cluding cleaning the interchangeable parts and the die table, for which around six hours are needed. Only 10 to 15 minutes are required to install the exchanged parts along with the die table. Between two batches of the same product, the tablet presses are partially cleaned using a vacuum cleaner as per the cleaning validation: the die table, dies, and punches as well as all other product-contacted parts remain in the compaction area, and only the fill shoe and inlet funnel are dismantled. This partial cleaning process can be

“Versatile, robust, and reliable” Hemofarm has been using Romaco Kilian technologies since 2002, and currently has eight Kilian tablet presses in total operating at its five production sites. The KTP series singlesided rotary presses in Vršac run in three shifts, either five (KTP 420X) or seven (KTP 590X) days a week. “The Kilian presses have proven to be very versatile, robust and reliable in our day-to-day work”, Djokic

reports. “And if any service issues arise, we also benefit from the Kilian team’s short response times and competent support – with Romaco, the customer really is king, and that’s something we very much appreciate.”

Company contact Susanne Silva Market Communications Romaco Group Am Heegwald 11 76227 Karlsruhe Germany T: +49 (0)721 4804 0 E: susanne.silva@romaco.com

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PHARMA PULSE Ensuring pharma compliance with testo data measurement technology Testo, being a market leader in testing and measurement sector, provides the best in class data loggers and data monitoring systems for the pharma division

D

ue to the crucial necessity and its direct impact on human health and welfare, pharma is probably the most important and critical sector among others. As a consequence of which, it becomes essential to store pharma products, vaccines, laboratory samples or units of blood at the right temperatures to ensure that they remain effective and that quality is maintained. Another reason for the pharma division to ensure safety measures and controlled environment is stringent regulations and inspection of the facilities. This elementary need for climate control can only be ensured with right data monitoring systems. Testo, being a market leader in testing and measurement sector, provides the best in class data loggers and data monitoring systems for the pharma division.

Ensuring end to end climate monitoring – Testo Data Loggers Pharma goods must be stored well in every situation as any deviation in the ambient temperature or humidity values may lead to deteriorated quality of the product. Testo data loggers can be used to test the optimum conditions for specific products or surroundings.

Temperature and humidity data loggers are often used in pharma industries to monitor the conditions in which drugs, medicines, vaccines are kept.

Not only storage, but during the transit of goods, testo transport data loggers are useful to measure the transport conditions.

The range of data loggers is very extensive. A temperature and humidity logger such as 174 T guarantees continuous monitoring in a storage or warehouse. Also, data loggers with multi channels for connecting external sensors and thermocouples, like testo 176 are available for ensuring secured work process in labs.

These data loggers are also

52 EXPRESS PHARMA February 2024

be modified and the audits can be easily complied with.

Service and calibration made easy Testo also has an established state-of-the-art NABL accredited service and calibration LAB in accordance with the standard ISO/IEC 17025:2017, that takes care of the after sales support locally from Pune.

Testo service and calibration facility is highly cost effective as it delivers international stan-

critical for production quality assurance where the temperature has to be frequently checked at various points in production processes. Using thermocouple probes, data loggers can also record data in the kinds of extreme temperature ranges. The probe's fast response also contributes in the validation processes and quality standard optimisation in QA units and clean room applications. These instruments are the most convenient and pocket friendly solution for all pharma application areas.

The testo Saveris 2 WiFi data logger system is the simple, flexible and reliable solution to humidity and temperature monitoring in cold storage area like blood banks. This innovative monitoring system is ideal for high product quality and eliminates manual work of reading out or documenting measurement data. With a secure online storage of all readings in Testo Cloud the data can be managed and analysed online by the user via smart phone, tablet or PC anywhere

and anytime. In case of crises and deviations, it is provided with an alarm by e-mail, or optionally by SMS. Another important and crucial application of a pharma industry involves validation of sterilisation and freeze-drying processes. Not only that, validating cleaning and disinfecting equipment is equally necessary.

In order to allow a seamless operating procedure, the validation process and the documentation work must be as efficient and smooth as possible which could be easily achieved with testo 190 data logger solution that has innovative data loggers for temperature and humidity, smart software and accessories.

Data compliance for audits and inspections Testo offerings are majorly related to the data security along with comprehensive analysis and evaluation of all the recorded measurement data.

Testo data loggers ensure continuous monitoring of temperature and relative humidity of

pharma products during production, storage or transit of goods. Real time data monitoring is important for the quality of pharma goods and also enables the supplier to improve the life of the goods. Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo data loggers and data monitoring systems. Our data loggers are EN 12830 and 21 CFR Part 11 compliant which ensure complete documentation of parameters, be it humidity, temperature or absolute pressure. They come with professional software where the data recorded cannot

dards very conveniently within a week’s time. Instruments of any brand/make can be calibrated and serviced locally maintaining necessary standards.

The accredited parameters include humidity, pressure, absolute pressure, contact type temperature, non-contact type temperature (infra red thermometer, thermal imager). In fact, Testo is the first and only lab in India to get NABL accreditation for Dew Point Temperature as well.

For more details, login to website www.testo.com or write back to info@testo.in

PHARMA PULSE

Procedures for tubing selection in pharma and biopharma applications Kabir Das, Sr Consultant - Business Development, Ami Polymer outlines crucial considerations for selecting tubing in pharma and biopharma applications, emphasising factors such as material compatibility, manufacturing conditions, regulatory standards, sterilidation methods, and the capabilities of the supplier

T

ubing are hollow cylinders used for fluid transport. Tubing has various forms like hose, pipe and many more. These are differentiated by the applications, flexibility, portability and many more.

Particularly in pharma and biopharma industry, the tubing, hose and pipes are used based on their criticality and applications. Media transfer, disinfectant application, fluid transfer, downstream & upstream applications, tangential flow filtration, media fill trial, fill finish, SIP, CIP, aseptic welding and sealing, single use technology, manifold, connectors and many more are the applications where tubing are used.

Tubing for single-use bioprocess and pharma applications has particular requirements. Among them are the ability to withstand various sterilisation processes, the delivery of favourable test results regarding extractable substances, and the absence of animal-derived ingredients.

Flexibility, permeability, performance in pumps, and welding and sealing capabilities are also common considerations.

Additionally, these critical industries should be aware of the environment in which the tubing is manufactured, association standards must be met and costs.

One of the most important concerns involves ingredients.

Those derived from animal sources are typically undesirable because of their potential effects on finished pharma and biopharma products. Silicone oils found in some tubing materials can also be detrimental to the end product.

Another crucial topic is validations and extractable studies.

Certain tubing materials like platinum-cured silicone are inherently purer than peroxidecured silicone and offer fewer substances that can be drawn out. Users of single-use tubing

Sr No

Description

Applications

Product

1.

Product in contact, Pressure less than 1.5 bar, sterilisation possibility, SIP and CIP

Single use, welding, Sealing, peristaltic pump

TUBING

2.

Product in contact, Pressure more than 1.5 bar, Sterilisation possibility, SIP and CIP

Repeated use, non-peristaltic pump application, Pressure and Vacuum application

HOSE

need to be aware of tests that should be performed to confirm that any extractable in the tubing’s make up do not have an affect the product flowing within.

Validations are also important, as they verify that the tubing selected has gone through necessary testing.

Coming to the point, even though tubing may look simple, the criticality is severe. As products are passed through these tubing, more care and attention is needed while selecting the suitable tubing. The following are some points which need to be kept in mind during tubing/hose selection.

1. Material of construction The most important consideration in the selection of suitable tubing for any application is the compatibility of the tubing material with the media to be contained. The minimum and maximum operating temperatures for the various tubing materials are also to be considered during selection process.

2. Material Ingredients Today’s pharma and biopharma manufacturers have found that the best way to eradicate animal ingredients and their possible effects on finished products is to start with processing components that do not contain any animal ingredients or animalderived ingredients. Another substance that can be troublesome is silicone oils. The oils can react with other components and leave a residue in the final product. Check with supplier to find out if tubing contains animal-derived ingredients or other undesirable elements.

3. Manufacturing condition Although tubing is sterilised prior to use, it makes sense to start with the cleanest possible product. Learn about the conditions in which the tubing is manufactured. The clean room manufactured product will be free from foreign particles which may contaminate the product in contact. Better to have information about how your tubing is produced. Is it produced in a clean room? If so, what level (ISO 6, 7, 8)? How is it handled and stored after manufacture? Has it been tested for contaminants by an independent laboratory?

4. Product standards The tubing being selected shall meet all your regulatory requirements. Will the tubing meet USP, FDA, ISO, BPOG, EU, TGA, ANVISA, or other standards? Some applications will demand that the tubing itself meet certain standards, while others will be satisfied when the tubing ingredients (the raw materials plus additives) meet those guidelines.

5. Sterilisation What methods can be used to sterilise the tubing? Autoclave (steam sterilisation), EtO (ethylene oxide) gas treatment, gamma irradiation, something else? These questions should be researched or posed to suppliers to help you make an informed decision. Another point to consider is whether you will receive tubing that is pre-sterilised or if you will handle that process. If you’ll be ordering pre-sterilised tubing, you need to make sure that the supplier’s process has been validated to

the degree of sterilisation necessary.

6. Tubing compatibility Absorption, adsorption, and permeability absorption (the penetration into the mass of one substance by another), adsorption (when molecules of a substance collect on the surface of another), and permeation (the diffusion of one substance through another substance) are details to examine when evaluating tubing. Materials differ greatly in how they contribute to these factors and the fluids or gases for which the tubing is intended need to be considered.

TPE (thermoplastic elastomer) tubing, for example, is much less permeable than typical silicone tubing. How does the tubing material you’re considering perform when it comes to these elements? Consider this if you use preservatives in your product.

7. Validations and extractables Tubing materials like platinum cured silicone are inherently purer than peroxide-cured silicone and offer fewer extractables (substances that can be drawn out of a material). Testing should be performed to confirm that any extractable or substances in the tubing’s makeup do not adversely affect the product flowing through it and vice versa. Has the tubing you’re considering undergone the necessary tests to ensure its suitability for your application?

Without validated test certifications, you may put your products, as well as lives, at risk.

8. Sealing and welding capabilities

Pharma and biopharma manufacturing often involves the retention of batch samples, which are specimens of the drug or substance being produced.

These liquid samples are frequently stored in small bags with tubing attached or within a section of the tubing itself.

This tubing must be permanently sealed without breaking sterility, preferably inner wall to inner wall using heat and compression, to prevent spillage and contamination. Tubing materials such as silicone cannot be heat sealed and require the use of mechanically applied fittings or connectors to stop flow or to join two pieces of tubing together. Other materials like thermoplastic elastomers work very well in typical heat sealing processes. Tube welding – a procedure where two open ends of tubing are thermally and permanently connected to each other – is another common function often employed in pharma and biopharma manufacturing. As with heat sealing, silicone cannot be welded but TPE’s can.

9. Multiple tubing materials Many pharma manufacturers use a peristaltic pump and silicone tubing in their processes.

But as noted above, tubing that can be heat sealed and welded is often needed at some point along the fluid path. Some manufacturers use one material for certain sections of their process, connect a piece of silicone tubing for the peristaltic pump section, and then return to the first tubing material. This setup involves multiple barbed fittings, cable ties, and the potential for

EXPRESS PHARMA

53

February 2024

PHARMA PULSE leaks and contamination, as well as human error. Situations have even occurred where an operator has installed the wrong section of tubing in a pump, resulting in lost pharma product, equipment replacement, and hours of time and labour. Tubing material such as TPE’s meet the requirements for a flexible, high purity, peristaltic pump tubing that may be welded and sealed, thereby eliminating multiple materials. Like silicone, certain TPE’s can be moulded into connections such as Y’s (wyes) and T’s (tees), further reducing the need for fittings and the possibility of leaks. Consider whether a single tubing material can be used in your application.

10. Cost When tubing is just one part of a fluid system, it is sometimes an afterthought. This is unfortu-

54 EXPRESS PHARMA February 2024

Tubing, hose and pipes are used based on their criticality and applications. Media transfer, disinfectant application, fluid transfer, downstream & upstream applications, tangential flow filtration, media fill trial, fill finish, SIP, CIP, aseptic welding and sealing, single use technology, manifold, connectors and many more are the applications where tubing are used nate because savings can be realised not only in the acquisition cost but in terms of labour and inventory as well. As noted in “Multiple tubing materials,” using one type of tubing has many benefits. It can reduce the initial purchase cost because your buying power is improved. For

instance, your cost to purchase 5,000 feet of a single material may be less than buying 2,500 feet of two different materials.

Using a single tubing material also decreases the cost of carrying inventory (stocking one tubing type verses two). Another benefit is lower labour ex-

penses. There are fewer connections to make, which means fewer fittings and tie wraps to purchase, too. One tubing material also saves engineering expenses, because there’s less design work involved.

11. Capability of the supplier Today’s fast moving world has

come up with SUS and customisation. The supplier shall be capable of providing customisation in short notice, shorter delivery periods and solution provider. During manufacturing due to various applications, at times tubing and hoses are needed in same MOC. This is a major challenge with various suppliers. Ami Polymer, India has a solution to these types of challenges. You can rely on Ami Polymer for quality products, with ease of customisation and shorter delivery periods. Contact Ami Polymer for your samples and queries.

Visit & contact www.amipolymer.com for more details Email - kabir@amipolymer.com Mobile - 9136660529

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