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18 HOWDEEPTECH IS TRANSFORMING DRUG DISCOVERY, MANUFACTURING, AND DISTRIBUTION
STRATEGY TECHNOLOGY
24 WHATEFFECT DOES X-RAY INSPECTION HAVE ON PHARMA PRODUCTS?
47
INDIAN BIOTECH START-UPS: NEED FOR PRAGMATIC, PRO-ACTIVE, PROGRESSIVE REGULATORY MILIEU
Regd.With RNI No.MAHENG/2005/21398.Postal Regd.No.MCS/164/2022 - 24.Printed and Published byVaidehi 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.
Now that the Union Budget 2024-25 has been analysed, feted and criticised, it is time to remember that budgetary allocations are only a signal of the government's intentions. The actions that follow and their implementation are more crucial. Given that we have around seven months before the next budget, it's fair to say that most postbudget criticism could be aimed at setting the stage for February 2025's Union Budget 2025-26.
Unfortunately, budgetary allocations are sometimes not matched by the capacity to absorb these resources, for a variety of reasons. For instance, budget documents show that Rs 75 crores has been allocated for the strengthening of the state drug regulatory system Budget Estimates (BE) 2024-2025. This allocation is slightly more than the Rs 72.14 crore set allocated for the same task in 2023-2024 (BE), of which Rs 52 crores are the Revised Estimates 2023-2024, indicating that actual spend on this expense head was less than the funds available.
This is surprising. The country's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has been undergoing a massive revamp, gearing up to start risk-based unannounced audits as per the revised Schedule M. Pharma companies with a turnover over Rs 250 crores are supposed to have upgraded to the revised norms by this July while smaller companies have more six months. Also consider that the CDSCO now audits not just pharma and medical device facilities, but also testing labs and more recently, has started with clinical research organisations.
Hopefully CDSCO has done the groundwork and is better positioned this year to fully utilise the allocated funds. In addition to medicines and medical devices, the CDSCO might soon be monitoring the quality of nutraceuticals as well.
So far, nutraceuticals flew under the radar until increased consumption and misleading advertisements during the COVID pandemic alerted authorities to the possible consequences.
The lure of nutra has caught the eye of quite a few pure play major pharma companies too, with a recent report from Avendus Capital, titled 'Navigating Domestic Formulations' sector, naming nutraceuticals as one of the chosen portfolio expansion strategies of pharma companies.
As nutra purchases do not require a doctor's prescription, there are concerns that long term unmonitored consumption, especially of improperly manufactured products, could have adverse reactions.
The increased pharma play in nutra has highlighted concerns that using the same manufacturing units for medicines and nutraceuticals could increase chances of contamination. Given the export revenues from pharma and nutra products, the safety concerns of such so-called 'mixed manufacturing' is clearly a recipe for disaster.
Thus in February 2024, the government formed a panel to review if nutra products need to be regulated by the CDSCO. Reports indicate that the panel members are expected to discuss the feasibility and safety implications of co-production, considering factors like potential contamination risks and adherence to stringent drug manufacturing protocols.
There has been a fair amount of advocacy on the part of the industry to protest this move. In a recent interview, I discussed this issue in more detail, with Adv Narendra Ahooja Vivek, currently Professor of Practice at Haryana’s MVN University and an advocate with the Punjab and Haryana High Court. As he retired as State Drugs Controller Haryana at Food and Drugs Administration Haryana and has also been associated with FSSAI, he is uniquely placed to give both perspectives.
In the interview, Adv Ahooja explains why he believes that regulatory bodies and regulations should complement each other,
If nutraceuticals shift from FSSAI to CDSCO,they will also come under price control.While this is good for consumers, industry sees red
and concludes that self regulation is the best form of regulation. He also discusses the implications of the shift of the nutra sector from FSSAI to CDSCO, explaining why such a shift would not be viable for the growth of the sector, especially MSME pharma and nutra companies. (https://www.expresspharma.in/expert-speak-advnarendra-ahooja-vivek-advocate-punjab-haryana-high-court-andretired-state-drugs-controller-haryana-at-food-and-drugsadministration-haryana/)
Sanjaya Mariwala, Executive Chairman and Managing Director of OmniActive Health Technologies and President of the Association of Herbal and Nutraceutical Manufacturers of India, concedes that segregating production lines to meet stricter quality standards is a welcome thought, but he cautions that it will be expensive and can cause supply chain disruptions and reduced exports. He reasons that a high-standard pharma plant should be allowed to make nutra products, but perhaps the opposite may not be acceptable, i.e. a nutra plant manufacturing pharma products.
He calls for a more collaborative approach between regulators and manufacturers, as understanding industry hurdles and offering incentives are crucial steps. "Both sides should strive for rigorous quality control, premarket reviews with clinical trials and accurate labelling to guarantee product integrity. Non-compliance must be met with penalties," suggests Mariwala.
In addition, Mariwala advocates for a unified regulatory body that would streamline processes and inject much-needed order into unethical and flawed practices. He believes that "this comprehensive strategy would foster a competitive, compliant industry primed for sustainable growth and global leadership.” Industry associations like Federation of Pharma Entrepreneurs (FOPE), a body representing MSMEs, has also reportedly lobbied hard to allow nutraceuticals to be manufactured in pharma manufacturing facilities. In a letter to the regulators, FOPE raises concerns about the new ScheduleM amendment, pointing out that it states that manufacturing premises must be exclusively used for the production of drugs, barring any other manufacturing activities. The letter points out that internationally, regulatory bodies such as the USFDA, EU, MHRA, MCC, and TGA allow facilities to manufacture both pharma products and dietary supplements, as long as they comply with pharma standards. (https://www.expresspharma.in/fope-writes-to-govt-raising-concernsabout-new-schedule-m-amendment/)
Outlining the impact on the Indian market, the FOPE letter informs that existing facilities, with approvals for both drugs and dietary supplements, may face significant disruption, affecting supply to the Indian market. Establishing new facilities could take up to four years, during which consumers may be deprived of their regularly consumed products. The industry association, through its letter, says that existing facilities, which adhere to high drug manufacturing standards, are equipped with high-quality infrastructure and protocols to prevent cross- contamination, should be allowed to continue with production of both drug and dietary supplements.
If nutra products do come under CDSCO, it follows that they will also come under price control. While this is good for consumers, it reduces the incentive for industry. This is just one of the many balancing acts that tangles that await Union Minister Shri JP Nadda as he juggles multiple roles as BJP National President, leader of the Rajya Sabha and Minister of Health and Family Welfare, Chemicals and Fertilizers. Hopefully the limelight will throw light on the many grey areas in health regulations.
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MARKET
Balancing cost and value with TCO
Total Cost of Ownership (TCO) is a crucial focus in the pharma industry,influencing sustainability and competitiveness.Optimising TCO across the value chain enhances profitability,affordability, and accessibility of medications,and allows for reinvestment in innovation and new therapy development.So, ExpressPharmareached out to a few pharma experts for their insights on strategies to optimise TCO
Optimising TCO in the pharma sector demands a holistic approach
Optimising TCO without compromising on quality and compliance requires a multifaceted approach, often involving:
Contract Development and Manufacturing Organizations (CDMOs): CDMOs offer specialized expertise and state-ofthe-art facilities for drug product development and manufacturing. By leveraging CDMO partnerships, companies can reduce capital expenditure, minimize operational costs, and gain access to advanced technologies and processes, without incurring the high costs associated with maintaining in-house capabilities.
◆ Leveraging technology: Continuously improving operating processes to increase yield, batch size, capacity, and
reduce cycle times and changeovers is crucial for cost optimization. Adopting advanced manufacturing technologies like continuous manufacturing, automation, and process analytical technology (PAT) can greatly improve efficiencies and product quality and reduce costs.
◆ Quality focus: By integrating quality throughout the process, companies can minimize non-compliance risk and expensive recalls. This involves identifying critical quality attributes and process parameters, and implementing strong controls for consistent product quality. This approach enhances reliability, streamlines regulatory approval, reduces time-to-market, and lowers costs.
◆ Supply chain manage-
Rajendra B Chunodkar, President – Manufacturing Operations,Lupin
ment: Pharmaceutical companies should focus on building resilient and flexible supply chains capable of adapting to market fluctuations and disruptions. Leveraging digital
supply chain solutions can enhance visibility and coordination across the supply chain, reducing inefficiencies and ensuring timely product delivery.
◆ Continuous improvement: Companies should invest in training and development programs to equip their workforce with the skills needed to implement and sustain improvement initiatives. Tools such as Lean Manufacturing and Six Sigma can be instrumental in driving continuous improvement and achieving operational excellence.
◆ Ensuring stringent compliance: Companies must establish robust quality management systems (QMS) to ensure adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. Regular audits,
Harmonisation of systems and practices across sites can improve efficiency
Pharma industry is facing significant challenges related to persistent cost inflation and pricing pressures leading to profit erosion which makes Total Cost of Ownership (TCO) very crucial for business sustenance.
The operational cost to the company grows year on year majorly attributed to rising input cost of raw materials, labour, machinery CAPEX and investments related to regulatory compliances which in turn squeeze the profit margin along with an intensifying market competition.
Having said that, it is imperative to look at avenues to reduce the cost of goods to sustain in the competition. Some of the initiatives that pharma organisations can take are:
◆ Efficient procurement and supply chain by developing alternate and cheaper source for key intermediates and other raw/packing materials without any quality compromise
◆ Embrace lean manufacturing by applying concepts of Kaizen, 5S, Focus PDCA and value stream mapping to identify redundancy in the processes and
SanjaySharma,Sr VP& HeadMS&T,Zydus
eliminate them.
◆ Improve plant efficiency without investing in new plants to increase throughput from the existing plant to make it more cost efficient
◆ Reevaluate legacy products to identify scope of any reformulation to make it more cost efficient
◆ Shift from manual processes to automation to optimise manpower cost
◆ Harmonisation and simplification of systems and practices across sites can improve efficiency
◆ Focus on product robustness
both internal and external, can help identify areas for improvement and ensure continuous compliance.
◆ Harnessing the power of data: By leveraging big data and advanced analytics, pharma companies can gain insights into their operations, identify inefficiencies, and make informed decisions to improve performance. Realtime data monitoring can enhance quality control and compliance, ensuring that products consistently meet regulatory standards.
Optimising TCO in the pharma sector demands a holistic approach that balances cost efficiency with quality and compliance while enabling continuous operational excellence and sustainable growth.
to minimise the failure cost and loss of market opportunity.
◆ Invest in technological advancements related to process analytical tools (PAT) and continuous manufacturing which reduces operational and testing cost and also improves process understanding and quality
◆ Stay regulatory compliant to avoid rework and remediations By adopting the above measures organisations can become more agile and efficient and ready to adapt to ever changing market dynamics
Establish KPIs to monitor TCO and identifyareas for improvement
Total Cost of Ownership is not only the asset’s purchase price, but it also includes, costs incurred on its maintenance, upgrades, wastes and rejects, operational cost etc incurred over its life span.
To effectively optimise TCO in the pharma industry, companies should focus on the following strategies:
1. Data-Driven Decision Making
◆ Performance metrics: Establish key performance indicators (KPIs) to monitor TCO and identify areas for improvement. These KPIs have to be reviewed periodically for monitoring the health and course correction to achieve the set goals.
◆ Asset and equipment selection: while bringing in any new piece of asset, one should dive deeper to understand overall lifecycle cost and not just the one-time procurement expenses. It’s like buying an insurance scheme
with periodic payment of instalments or investing once to get the insurance cover and regular paybacks as well.
◆ Though initially it may look like high cost but then the consistent realisation of quality output, improved regulatory compliance with authentic & accurate data, lower repairs and maintenance costs, low wear and tear, bare minimal reject generation, improved yields, lower wastages, less resource utilization, lower power or utility consumption, ease of operation etc. quite often justify the initial high price. And this is the only way, one should calculate TCO for any asset.
2. Supply chain optimisation: (Assuming supplier relationship management for better terms and quality in place along with mitigation of any risk on supply chain disruption, agility to turn around with robust input supplies and customer service levels)
◆ Inventory management:
Sr
Implement efficient inventory control systems to reduce not only holding costs but also stockouts. With the interest rates going up drastically, it makes more sense to control inventories at all levels.
3. Process improvement
and automation
◆ Lean manufacturing: Eliminate waste and inefficiencies in production processes. This includes reducing cycle times, improving yield rates, and minimizing energy consumption, measuring equipment OEE, having autonomous maintenance process in place for upkeep of plant and machinery.
◆ Quality by Design (QbD): Incorporate quality into the product development process to minimise quality events happening on the shopfloor and there is no market complaint, rework and/ or rejections.
4. Technology Adoption
◆ IoT: Using technology to monitor equipment performance and optimise maintenance schedules (adopting predictive maintenance,) and Leverage digital technologies to streamline operations and reduce costs. In pharma, capturing data directly from the machines may save time and
resources and improve regulatory compliance due to digital oversight of the entire shopfloor and quality.
5. Sustainability and energy efficiency:
◆ Green initiatives: Use of technology to monitor energy consumption patterns and optimise the same. Implement practices to reduce energy consumption, use alternate greener sources of energy like solar or wind and reduce waste generation at all levels.
◆ Cost-benefit analysis: Implementation of various sustainability initiatives will not only reduce the operational costs, but will reduce carbon footprint, fetch in better investments, and improve market penetration. By implementing these strategies, pharmaceutical companies can achieve significant TCO reductions while maintaining the highest standards of quality and compliance.
Amultifaceted approach to TCO can foster innovation,sustainability, and continuous improvement
Key strategies for optimising TCO include: Streamlining procurement processes
◆ Vendor management: Building long-term partnerships with reliable suppliers to secure bulk discounts and favourable terms
◆ Just-in-time inventory: Reducing holding costs and waste by ensuring materials are available as needed
Enhancing production efficiency
◆ Lean manufacturing: Adopting principles like value stream mapping and continuous improvement to eliminate waste and enhance productivity.
◆ Automation and technology integration: Investing in advanced automation and
data analytics to optimise workflows and reduce errors.
Optimising logistics and distribution
◆ Efficient supply chain management: Implementing robust practices to minimise transportation costs and ensure timely delivery.
◆ Cold chain optimisation: Utilising IoT-enabled temperature monitoring and advanced refrigeration for temperature-sensitive products.
Focusing on qualityand compliance
◆ Regulatory adherence: Ensuring strict compliance to avoid costly penalties and recalls.
Dr Girish Dixit,Executive Director,
Eisai Pharma
By adopting a multifaceted approach to TCO,pharma companies can achieve significant cost savings, enhance profitability,and maintain high-quality,affordable medications
Sustainabilityinitiatives
◆ Green manufacturing practices: Reducing environmental footprint and costs
◆ Quality assurance programs: Implementing Good Manufacturing Practices (GMP) and quality management systems to maintain high standards.
through energy-efficient processes and waste minimisation.
◆ Recycling and aste management: Developing efficient systems to repurpose waste and optimise resource utilisation.
By adopting a multifaceted approach to TCO, pharma companies can achieve significant cost savings, enhance profitability, and maintain high-quality, affordable medications. This holistic strategy fosters inn ovation, sustainability, and continuous improvement, driving long-term success in a competitive market.
Howdeep tech is transforming drug discovery,manufacturing,and distribution
Madhur Singhal,Managing Partner,Pharma and Lifesciences at Praxis Global Alliance examines how the pharma industry is undergoing a revolutionary transformation with the integration of advanced technologies like AI,quantum computing,and blockchain.It also explores the profound impact of these deep tech innovations on various crucial functions in pharma,highlighting their potential to enhance efficiency,innovation,and patient care
The pharma industry is experiencing a transformative shift with the infusion of advanced technologies into its core operations. From drug discovery to clinical trials, manufacturing, distribution, and marketing, groundbreaking technologies such as generative AI, quantum computing, gene editing, nanotechnology, and blockchain are revolutionising the way pharma companies operate. We discuss the profound impact of deep tech on various aspects of the pharma sector, highlighting its potential to enhance efficiency, innovation, and patient care.
Drug discoveryand development
The infusion of advanced technologies is penetrating the core of pharma operations and revolutionising drug discovery, clinical trials, manufacturing, distribution, and marketing. Groundbreaking technologies like generative AI and quantum computing are taking center stage as they expedite the drug discovery and development trajectory by predicting drug interactions with specific protein targets and optimising molecules for chemical reactions like protein folding. Gene editing technologies such as CRISPR help edit genes by precisely cutting DNA and harnessing natural DNA to modify the gene in the desired manner. Soon, CRISPR might make it possible to correct mutations at precise locations in the human genome to treat genetic causes of disease. Nanotechnology is also being employed to en-
hance drug delivery precision for effective targeted therapies, while high-throughput screening of large compound libraries aids in the identification of molecules for personalised treatments.
Clinical trials and approvals
The trials and approvals process integrates in-silico experiments, which involve computer-based simulations and modelling, revolutionising the pharma sector by accelerating drug discovery and development processes. These experiments enable virtual screening of drug candidates, predicting their efficacy and toxicity, thus reducing the need for extensive in vitro and in vivo trials. This approach helps in identifying potential issues early, optimising clinical trial designs, and expediting regulatory approvals by providing robust data on drug interactions and safety profiles. Additionally, blockchain technology enhances the credibility of trial results and expedites the regulatory approval process by facilitating transparent sharing of trial data.
Manufacturing and packaging
Deep Tech is revolutionising the manufacturing and packaging sectors by introducing innovative materials and advanced technologies. In manufacturing, smart technologies like IoT sensors for quality control are being utilised to provide real-time data, optimising pharma production processes. These sensors monitor various parameters such
as temperature, humidity, and machinery performance, ensuring consistent product quality and reducing waste. Additionally, the data collected facilitates predictive maintenance, minimising downtime and improving overall operational efficiency. In packaging, new advanced materials are being introduced such as Nano silver coatings that possess antimicrobial properties, which help to effectively reduce the risk of contamination. Additionally, they enhance the barrier properties of packaging, prolonging shelf life by preventing oxidation and microbial growth whilst also reducing package weight and improving durability. Furthermore, AI and ML models can optimise the production process by optimising resource allocation, enhancing efficiency, and reducing costs.
Warehousing and distribution
Within warehousing and distribution, IoT sensors play a crucial role in ensuring the integrity of climate-sensitive drugs through precise climate control. These sensors continuously monitor and regulate en-
vironmental conditions such as temperature, humidity, and light exposure, p reventing degradation of drugs. Furthermore, storage optimisation is achieved through AI-based automated systems that manage inventory with high efficiency, reducing human error and ensuring quick, accurate retrieval of drugs and equipment. Additionally, through blockchain, we can create an immutable ledger for all stock items that enables easy tracking, reducing wastage due to stock expiry.
Marketing
and fulfilment
Deep tech's influence extends to marketing as AI/ML models can be used to predict demand accurately by identifying key market trends and thus optimise distribution strategies for companies. Advanced verification methods, including QR code scanning and blockchainbased applications, ensure secure and reliable drug authentication, enhancing trust and transparency in the pharma supply chain. Furthermore, drones can play a crucial role in the delivery of medical equipments, especially during emergencies, ensuring timely and efficient fulfilment. Equipped with advanced GPS and real-time tracking systems, drones enhance the reliability and precision of pharma logistics, ensuring critical medical supplies reach patients quickly and safely.
Industryadoption and future outlook
Industry leaders, including Johnson & Johnson, AmerisourceBergen, Pfizer,
Cipla, and others, stand as torch-bearers in embracing these transformative technologies. For instance, Johnson & Johnson is leveraging Deep Tech to transform healthcare by using AI for early disease detection, drug discovery, and surgical efficiency. AI algorithms are helping them diagnose diseases like pulmonary hypertension and cardiac amyloidosis earlier and more accurately. Furthermore, the company is using AI in drug discovery to accelerate the development of targeted treatments by analysing vast datasets to identify genetic mutations. This collective adoption underscores deep tech's pivotal role in propelling the pharma industry toward heightened efficiency, innovation, and ultimately, enhanced patient care.
The adoption of deep tech in the pharma industry is paving the way for unprecedented advancements in drug discovery, manufacturing, and distribution. Industry leaders such as Johnson & Johnson, AmerisourceBergen, Pfizer, and Cipla are embracing these transformative technologies to enhance healthcare outcomes. By leveraging AI for early disease detection, drug discovery, and surgical efficiency, these companies exemplify the potential of deep tech to drive innovation, improve efficiency, and ultimately enhance patient care. The continued integration of advanced technologies into pharma operations promises a future of heightened efficiency, innovation, and better health outcomes for patients worldwide.
GenAI: Expediting drug discoverywhile reducing development costs
Raj Babu,Founder & CEO of Agilisium highlights that GenAI is transforming drug discovery by reducing time and costs.By leveraging advanced data analysis and predictive modeling,GenAI accelerates each stage,from target identification to clinical trials,enabling faster,cost-effective delivery of innovative therapies
Developing new and innovative drugs has always been a time-consuming and expensive endeavor. On average, it takes 12 to 15 years for a drug to go from molecule to market, with 7 to 10 years dedicated to preclinical research. Unfortunately, only one out of ten drugs that enter clinical trials are approved. Recent research by McKinsey indicates that it costs up to $2.8 billion to develop a new drug.
While traditional drug discovery includes vast laboratory research, starting with target identification, validation, assay development, High Throughput Screening (HTS), lead optimisation, ADME properties and animal model efficacy, broad preclinical testing, and multiple phases of clinical assessment, it is complex and creates huge burdens in finances and time.
Fast-paced technological changes are underway, nevertheless, to drive a sea change in the pharma industry. One of the most promising developments has to do with the use of generative AI in drug discovery. But how precisely is GenAI speeding up the drug discovery pipeline while cutting down on development costs?
Before delving into Generative AI solutions for rapid drug development at a reduced cost, let's examine the major challenges faced across the stages of drug discovery.
Major challenges in traditional drug discovery
The different stages of drug discovery are inherently challenging. At the stage of discovery itself, molecular modeling
is complex, genomics and proteomics data are integrated inefficiently, and high-throughput screening is limited and often missing the most promising candidates. Moving into the preclinical phase, the selection of a viable drug candidate from thousands of compounds is enormously selective, especially when the human response is translated from animal models and overall drug safety is ascertained through toxicity studies. Biologics have less than a 10 per cent success rate in clinical trials, with costs reaching up to $310 million per trial. Realtime data analysis, adaptive trial designs, and patient
stratification are all part of the bundle of challenges too. Generative AI addresses many of these challenges with solutions focused on better quality, accuracy, and efficiency, reimagining the drug discovery pipeline.
Challenges to solutions
Now, let us see why generative AI solutions are changing the drug discovery pipeline. This is because newer developments such as decreasing costs of high-throughput sequencing technologies, wholegenome sequencing, digitiation of health records, and increased computing capabilities have resulted in a deluge
of biomedical data. These developments have placed GenAI as a potential solution for the effective analysis of these large datasets, hoping for quicker drug development using data-driven methods.
Role of GenAI in target identification,lead optimisation,and clinical trials
Target identification: Scientists spend countless hours trawling through patents, scientific literature, and trial data just to work out diseases and potential drug targets. A grueling task, often in large volumes, means it isn't done thoroughly enough. LLM-powered knowledge extraction hands the tough duty of understanding the analysed text, images, and other types of data over to AI. In contrast to old methods using natural language processing, new AI tools like GenInsights can help delve deeper into medical contexts. This will help the researcher specifically in phases like lead optimisation and target identification by offering the opportunity to ask detailed questions and switch tasks with ease without the need for extensive training to customise information for special needs, adding more evidence in the process. While reducing the time taken to identify the target, GenAI is also likely to reduce the costs associated with iterative cycles of synthesis testing!
Lead optimisation: In the drug discovery process, once the target is identified and validated, the assay is developed, and millions of small molecules are screened through High Throughput Screening
(HTS). From millions of molecules, a few thousand molecules are selected as leads. Lead-to-lead optimisation processes are made faster with advancements in AIbased drug discovery tools for drug binding, homology modeling, toxicity prediction, drug filters like the Lipinski rule, reactive molecule filtration, and PK-PD modeling. Also, with extensive data, these models develop deep insights into large and small-molecule chemistry. GenAI models help predict parts of molecules, such as atoms in small molecules or amino acids in larger ones.
This could potentially shorten preclinical testing timelines by 20 to 30 per cent, allowing hopeful candidates to transition to clinical trials more quickly.
Preclinical testing: The capability of knowledge extraction that empowers researchers to decide on the medical conditions or indications a particular molecule will target is one of the critical decisions in biopharma. Of course, traditional methods would run the risk of missing real key evidence. Pharma companies have started using GenAI in the preclinical phase to analyse Real-World Data (RWD) and Molecular Knowledge Graphs, to discover new insights in indication selection. RWD is an underappreciated resource for indication selection, and models analysing medical events as texts to show patient-related similarities. Molecular knowledge graphs can chart proteinpathway relationships that yield new indications that were experimentally validated
in preclinical models.
Clinical trials: In clinical trials, where time is money and the most important resource, GenAI makes all the difference. It simulates trial scenarios and predicts compound efficacy and safety profiles, reducing the number of trials and shortening the time frame of regulatory approval. That's expected to reduce the cost by up to $300 million per successful drug brought to market. Overall, GenAI provides perfect optimisation of each phase of drug development besides allowing researchers to find new areas of inn ovation, ultimately giving life-saving therapies to patients worldwide by increasing the speed, cost-efficiency, and success rate. While GenAI is revolu-
While AI is transforming the possibilities of drug discovery,ethical considerations arise,and responsible innovation must be upheld.These include mitigating bias through diverse datasets, ensuring transparency
in
algorithmic decisionmaking,protecting patient
privacy,providing
equal access to medicines,and operating within the strictest regulatory boundaries
tionising drug discovery, it is also empowering small pharma and research institutions to be more competitive.
GenAI and its impact on small pharma and
research institutions
Generative AI now is well known, for its increasing contribution to new prescription drug approvals and new molecular entities (NME). The discovery of such NMEs by
small pharma drastically surged from 31 per cent to 64 per cent in just ten years. Also, GenAI solutions enhance the quality and precision of drug development by 60–80 per cent, hence highlighting their
centre stage in reshaping the pharma world.
Now, let us look at use cases where they use GenAI. AI-driven protein design by small pharma companies: Small pharma companies are looking to leverage generative AI to help biologists design better proteins to realise their functions. These companies are using AI models running on huge datasets of protein sequences and lab-generated proprietary data to speed up the production of bio-based products required for human and environmental health. This could turn any research and development into a very high-paced process.
Disease prediction models by research institutions: Research institutions in emerg-
ing countries like India have access to country-specific disease data. For example, cervical cancer or breast cancer-related statistics across multiple Indian states. These research institutions are converting their raw data into insights using GenAI and even going beyond - such as developing a disease prediction model app that can help doctors and patients identify potential comorbidities.
Clinical study reports (CSR) to research papers: Another area where research institutions and a few emerging pharma companies are leveraging GenAI is shortening the time taken to publish their research papers. They feed CSRs into their custom GenAI models and receive research papers (journal manuscripts) with 95 per cent accuracy, saving a significant amount of time and effort.
Although we have many use cases that are enhancing the drug discovery process, we should also consider the ethical side of using GenAI.
Ethical considerations in drug discovery
While AI is transforming the possibilities of drug discovery, ethical considerations arise, and responsible innova tion must be upheld. These include mitigating bias through diverse datasets, ensuring transparency in algorithmic decision-making, protecting patient privacy, providing equal access to medicines, and operating within the strictest regulatory boundaries. By addressing these considerations, we can provide assurance and fairness in every medical advancement.
Conclusion
Now is the time to reimagine the drug discovery strategy using the power of GenAI. This less-traveled road, like any new technology, will come with its challenges and unique opportunities. As discussed earlier, with the help of GenAI, we can accelerate drug discovery, reduce its cost, and enable swift treatments while upholding our commitment to ethical principles that prioritise pa-
tient well-being and scientific integrity.
Pharma companies and research institutions, whether
big or small, should take a systems-based approach when utilising GenAI, which means having a holistic view. This in-
cludes balancing investments, returns, risks, and the value delivered to stakeholders. Achieving this will not only re-
quire bold an d innovative leadership but also a culture that always puts 'humanity' first.
LABWARE ®
What effect does X-rayinspection have on pharma products?
Pharma manufacturers continue to have concerns over the effect that x-ray inspection could have on their medicines.Are they right to be concerned? Mike Pipe,Head of Global Sales of Mettler-Toledo Safeline X-ray,emphasises that research shows x-ray inspection does not compromise pharma products
X-ray technology is an effective way of inspecting pharmaceutical products for a range of factors, among them being certain kinds of contaminant, fill levels, damaged or missing components, and damaged packaging.
Without doubt, the pharma sector is waking up to how useful x-ray inspection can be, and how it can improve matters of cost, efficiency and waste. The European Medicines Agency (EMA) has issued rules regulating the exposure of drugs to x-ray, in its document “The use of Ionising Radiation in the Manufacture of Medicinal Products” (3AQ4a). This guidance advises that irradiation may be used for microbial decontamination, sterilisation or other treatments in the manufacture of medicinal products, and that manufacturers doing so should refer to the Guide to Good Manufacturing Practice (Volume IV of “The Rules Governing Medic-
The advantages of x-ray inspection are considerable, giving pharma manufacturers the opportunity to perform presence and integrity checks, physical contamination checks, and fill level checks that would otherwise be difficult and time-consuming to carry out
inal Products in the European Union”) and in particular to Annex 12, on ionising radiation used in the manufacture of medicinal products.
The Annex explains the responsibilities and processes required for using ionising radiation with medicinal products, including different types of irradiation, validation and documentation process, and dosimetry to measure absorbed doses.
However, there is often still a sticking point – a nagging doubt that some manufacturers have about installing x-ray inspection on their pharma production and packing lines. It is the worry that inspecting products using x-rays will cause the product’s therapeutic efficacy to be compromised. This means that radiation from x-ray inspection will fundamentally alter chemical compounds and break the co-
valent bonds of the molecules that constitute the drug.
At Mettler-Toledo, we are asked about this issue often, and of course it is not something to make light of. Any responsible manufacturer would want to ensure that its product reaches the end user in optimum condition. Our answer to this kind of query, however, is threefold.
Firstly, that the radiation levels used in this type of inspection are incredibly low and are directed upon each product for a fraction of a second.
Secondly, that the research so far carried out in this area (see below) supports the hypothesis that there is no evidence of damage to pharmaceutical products after x-ray product inspection 1
Finally, we can reassure them that, as a responsible manufacturer, we would be happy to work with them on testing and analysing what effect, if any, our inspection technology would have upon their specific pharmaceutical product.
The nature of X-ray
One aspect of this subject that needs to be understood at the outset by pharmaceutical manufacturers is the nature and intensity of the radiation produced by x-ray systems for product inspection. There are many natural sources of radiation that surround us –whether they be cosmic rays from space, or naturally-occurring radioactive materials on Earth, including uranium or radon gas. Wherever you may be on the planet, you are being subjected to some level of this “background” radiation.
Alongside these natural sources of radiation are manmade sources, which include medical equipment, security scanning and inspection systems such as those used in xray inspection. Those created within inspection equipment are only transmitted when the equipment is switched on. They can be turned on and off at will, unlike background radiation. Provided that safety guidelines are followed, there
is no risk to the operators of such x-ray inspection systems.
In respect of the effect of
these x-rays on pharma products, it should be noted that the radiation dosage to which products might be exposed is
both very small in comparison to other man-made sources such as those noted above, and that the length of time of
exposure to this energy is very short – typically, pharma products such as tablets are exposed to x-ray inspection
TECHNOLOGY
energy of around 0.11 milligray (mGy) for less than 0.2 seconds. A frequent airline flyer will be exposed to around 200 μ Sv (microsieverts) per year, which is around double the dosage size (note: 0.1 mGy equals 100 μ Sv).
The US Food and Drug Administration (FDA) has estimated that the dose level received by an object going through an x-ray inspection system is lower than the background radiation dose level that the same object will be exposed to over a single day. The FDA also emphasises that whether consuming medicines or other products that have been inspected by x-ray, no real danger has ever been established, stating on its website that “there are no known adverse effects from eating food, drinking bever-
A2015 Nagoya City University study revealed that drug tablets exposed to x - ray doses upto a million times higher than typical levels,maintained their quality,with no changes in dissolution, disintegration,or hardness
ages, using medicine or applying cosmetics that have been irradiated by a cabinet x-ray system used for security screening” 2
Formal research
There has been some scientific research into the effect of x-ray inspection on pharma products. The main study was conducted and published in 2015 by scientists at the Department of Drug Delivery
and Nano Pharmaceuticals, in the Graduate School of Pharmaceutical Sciences, Nagoya City University, Japan.
In this study, three pharma drug tablets were exposed to x-ray doses from 0.34 milligray , which is three times the typical dose delivered by x-ray inspection, up to 300 Gray (Gy), which is about one million times the typical dose. The drugs tested were acetaminophen, loxoprofen and
mefenamic acid tablets. Following exposure, the samples were evaluated in formulation tests for dissolution, disintegration and hardness and were found to exhibit almost the same profile as samples that had been exposed to 0 Gy of radiation, revealing, according to the researchers, that exposure to x-rays did not affect the pharma quality of the tablets. The samples were also
subjected to accelerated temperature and humidity tests in combination with x-ray exposure, and this also did not affect the pharma quality. The conclusion made was that even exposure to x-rays at much higher levels than product inspection systems use had no significant effect on the efficiency or other properties of these drug tablets 3
An earlier study (in 2012 –by Robert Bosch Packaging Technology and the PHAST Society for Pharmaceutical Quality Standards4) looked at the effect of two hours of x-ray exposure on the pharma substances tramadol HCI and nifedipine. No degradation was observed in either substance, even after this much longer x-ray inspection exposure time.
August 2024
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Test and analyse
While these results strongly suggest that the low radiation dosages and split-second exposure times of x-ray inspection systems have no significant effect on pharma products, it would be unscientific to say that these results apply across the board. The simple fact is that not all formulations have been studied.
However, there is a growing weight of evidence from the day-to-day operation of xray inspection in the pharma field, where inspected drugs continue to operate as they should, without detriment to patient safety. Even so, if pharma manufacturers still have concerns in this regard, their x-ray supplier should move to address them quickly.
At Mettler-Toledo, we are very happy to work with pharma companies, combining our Safeline x-ray inspection systems with the manufacturer’s own laboratory capabilities to undertake thorough testing and analysis. We are confident that the results achieved would put their mind at rest.
To conclude, the advantages of x-ray inspection are considerable, giving pharma manufacturers the opportunity to perform presence and integrity checks, physical contamination checks, and fill level checks that would otherwise be difficult and time-consuming to carry out. These quality assurance checks are completed within energy dosage levels that available research and experience suggests is safe and has no negative effect on the quality of the product.
For more information click here or visit www.mt.com/xraypharmaeguide-pr
1. https://www.fda.gov/radiation-emitting-products/security-systems/frequently-askedquestions-cabinet-x-ray-syste ms
2. https://www.fda.gov/radiation-emitting-products/security-systems/frequently-askedquestions-cabinet-x-ray-syste ms
3. Kazuaki Uehara, Tatsuaki
Tagami, Itaru Miyazaki, Norikazu Murata, Yoshifumi Takahashi, Hiroshi Ohkubo & Tetsuya Ozeki (2015) Effect of X-ray exposure on the pharma-
ceutical quality of drug tablets using X-ray inspection equipment, Drug Development and Industrial Pharmacy, 41:6, 953-958, DOI:
10.3109/03639045.2014.917093
4. Martin Vogt, Elke Sternberger-Rutzel, Manuel Birke & Christoph Jacobs (2012) Influence of X-ray radiation as PAT
method on the model substances tramadol HCl and nifedipine compared to the influence of UV-Vis radiation, TechnoPharm 2, Nr. 3, 1–12
Over 100 pharma R&D leaders and experts came together to explore the latest advancements in pharma formulation and drug delivery.The event highlighted innovative strategies,emerging technologies,and collaborative approaches,setting the stage for India's next growth phase in pharma FR&D
Welcome Address
Express Pharma hosted the seventh edition of the Formulation Development and Drug Delivery (FDD) Conclave at Le Meridien, Hyderabad. The FDD Conclave 2024 brought together formulation scientists and R&D leaders to discuss current and future trends, growth drivers, and challenges under the theme "Forging the path for tomorrow's therapeutics."
The event commenced with a Welcome Address by Viveka Roychowdhury, Editor of Express Pharma & Express Healthcare. She spoke on the vision of the FDD Conclave and explained that it aimed at recognising the tireless efforts of pharma formulation R&D champions and creating a knowledge sharing platform for FR&D scientists.
Roychowdhury's address as followed by the lamplighting ceremony. The participants of the first panel of FDD Conclave 2024, joined Roychowdhury on stage to light the ceremonial lamp and give an auspicious start to the event.
Chatbar,CuraTeQ Biologics and Manish Jain,Cilicant
Innovations in active packaging
Dr VivekKumar Jha,CTO,Cilicant
FDD Conclave 2024 comprised of several technologies and solutions for the pharma industry . One such presentation was on the innovations in active packaging which are vital to secure the safety and efficacy of medicines. Dr Vivek Kumar Jha, CTO and Ms Komal Bhavsar, AGM - Busi-
ness Development (Pharma), Cilicant, gave insights on this topic. They highlighted some challenges in safeguarding medicines such as oxygen moisture exposure, and odour.
They also informed that to resolve these issues, Cilicant has introduced Oxibide; a self-activated oxygen ab-
Komal Bhavsar,AGM - Business Development (Pharma),Cilicant
sorber. Oxibide is a self activated oxygen absorber and comes in a leak-proof and non-perforated canister form. It is designed to be compatible with any other type of desiccant and when used along with a moisture-absorbing desiccant, it can preserve medicines and enhance their shelf life.
The speaker also emphasised that with its line of products, Cilicant aims to aid the pharma industry by providing effective active packaging solutions. They can eliminate packaging and storage issues of medicines and ensure optimal shelf-life, safety and efficacy.
L-R: Viveka Rychowdhury,Express Pharma; Dr Ravikumar N,MSNLaborataries; Dr Kamal Kumar Upadhyay,Biological E; Dr Meka Lingam, Lee Pharma; Dr Chandresh
at the lamp lighting ceremonyof FDD Conclave 2024
The first panel discussion at FDD Conclave 2024 aimed to explore cutting-edge advancements and breakthroughs in drug formulation, including nanotechnology and personalised medicine while emphasising the crucial role of FR&D in India Pharma Inc. Panelists also highlighted areas that need development for the holistic growth of the industry. The session was moderated by Viveka Roychowdhury, Editor, Express Pharma & Express Healthcare and included FR&D experts
cover )
VP- R&D, CuraTeQ Biologics.
The discussion began by stating that affordable generics and affordable formulations are India's USP. However, to accelerate growth we need to look towards inculcating value through differentiated and novel formulations.
Expanding on the point put forth, the panellists agreed that though India is the ‘Pharmacy of the World’ the industry needs to make huge strides to cater to a larger public and meet varied needs of patients. They also emphasised that to serve the needs of our country, patient-centricity should be the foremost objective of an FR&D scientist. Here the challenge not only lies in creating novel formulations but also in modifying current formulations to optimise medication.
Innovations in biologics and biosimilars were also discussed. The panel informed that a key aim was to reduce volume of drug dose by increasing its concentration and finding alternative drug delivery systems that are less invasive yet effective for patient compli-
KEYTAKEAWAYS
◆ FR&D scientists have a huge role to playin driving innovation in India Pharma Inc as theystrive to offer cost-effective formulations with optimised dosages,and patient-centricity
◆ So,we need to cultivate and incentivise the right talent to build scientific acumen to accelerate progress in FR&D
◆ We need robust strategies in place,including the right technologies,effective policies,streamlined processes and clear regulatorypathways,to develop novel and complexformulations
◆ Affordable generics and affordable formulations are India's USP.But,nowwe need to drive value through differentiated and novel formulations to accelerate our growth story.
◆ Emerging technologies will help record and document data effectively,choose the right regulatorypathways and commercialise safer formulations faster.
ance. The experts pointed out that biopharma is also looking at possibilities beyond existing treatments and emphasised the need for innovations in existing formulations to target two therapies with one medicine. They informed that India Pharma Inc is also looking beyond the lucrative business of generics, to research and develop complex
formulations, NCEs, and peptides. To achieve success in these endeavours, the industry will require advancements in the allied sectors, knowledge of what regulatory bodies demand, and skilled talent. Therefore, the industry must have robust strategies in place, including right technologies and effective policies. Especially to streamline
Patient-centric product design
At FDD Conclave 2024, Abhijit Gothoskar, Technical Expert at Sigachi Industries, presented on the importance of patient-centric product design in pharma manufacturing. He accentuated that by prioritising user experience, this approach enhances patient satisfaction, adherence to treatments, and overall health outcomes.
Gothoskar defined patient centricity as recognising individual patient needs in medicine design, considering physiological, physical, psychological, and social characteristics. He highlighted tablet morphology, noting the FDA's guidance to keep tablets under 21 mm for easier swallowability, especially for older patients and those with conditions like Parkinson’s Disease or arthritis.
He also discussed orally disintegrating tablets (ODTs) which rapidly disintegrate on the tongue, improving patient convenience. Moreover, Gothoskar emphasised the importance of excipient selection for taste, mouthfeel, and content uniformity, especially for older patients.
He further presented Sigachi’s solutions including HiCel HFS for improved tablet hardness and disintegration, and
The panel concluded that as India’s pharma landscape strives to offer costeffective formulations, optimised dosages, and patient-centricity, FR&D scientists have a huge role to play in fostering novel ideas and discoveries as well as in driving innovations.
Patient-centric product design prioritises user experience, enhances patient satisfaction, adherence to treatments,and overall health outcomes
HiCel CE15 for chewable tablets with minimal chalkiness and better mouthfeel. He informed that their BARETab excipient premix is designed specifically for ODT formulations, enhancing productivity and patient experience.
He concluded by asserting that Sigachi’s focus on patient-centric design aims to create more effective and user-friendly pharma products.
Transdermal and oral film drug deliverysystems: Process know-howand related equipment
Giovanni Costa, Regional Sales Manager, Harro Hoefliger gave a presentation to provide insights into developing innovative and effective ways to administer medications. For instance, he elaborated on ODF drug delivery systems that quickly release the drug by dissolving or adhering in the mucosa with saliva. He also informed that ODF sales prediction is around €1-2 billion.
Simultaneously, he pointed out that transdermal drug delivery routes provide the advantage of controlled release of medication over other types of medication delivery such as oral, topical, intravenous, or intramuscular.
Costa also stated that there is lot of progress in novel drug delivery forms such as microneedle array patches for intradermal applications of vaccines. Intradermal application is more beneficial as a larger amount of defence cells are present here, resulting in a higher immune response.
The different forms of microneedle technologies such as coated microneedles, dissolving microneedles and hollow microneedles can meet varied needs of drug application. A few examples also include a reusable applicator with an interchangeable microneedle patch.
He concluded with a promise that Harro Hofliger, as a technology partner,
Giovanni Costa,Regional Sales Manager,Harro Hoefliger
ODFdrug delivery systems can quickly release the drug by dissolving or adhering in the mucosa with saliva. Simultaneously, transdermal drug delivery routes provide the advantage of controlled release of medication over other types of medication delivery such as oral,topical, intravenous,or intramuscular
can help pharma companies take their ideas from the lab to market.
Panel discussion: Beyond pills-Deep diving into revolutions in drug delivery
At the recently held FDD Conclave 2024, a very interesting panel discussion on “Beyond pills: Deep diving into revolutions in drug delivery” ensued. It explored significant advancements in drug delivery systems, marking a shift from traditional pills to more innovative methods.
Vinod Arora, Principal Advisor at IGMPI, moderated the panel, which included Dr Sandhya Shenoy, Associate VP-R&D - Formulation, IPCA Laboratories; Dr Rakesh Kumar Bhasin, Head R&D (Formulations), Biocon; Mathivanan Rajagopal, VP and Head - R&D, Axxlent Pharma Science; Mahesh Gavasane, GM and Head of Downstream and Formulation, BSV; Dr Sajeev Chandran, VPPharma R&D, Lupin; and Dr Anil Kumar R, Sr VP-R&D & MSAT, Strides Pharma.
The moderator set the tone and context for the discussion by noting India's significant role as the “Pharmacy of the world’ and the need for more innovative and advanced solutions to drive India Pharma Inc’s next stage of growth. Moving to the evolution and revolutions in drug delivery, the panel was in unison that patient needs and advancements in science and technology were driving progress in this field.
Evolutions and revolutions in various methods and forms of drug delivery were explored and examined during the course of this discussion. The panelists began with biologics and cell and gene therapy, highlighting progress in these areas. They noted how gene therapy offers hope when other therapeutic methods have failed but also acknowledged the high costs associated with these therapies. However, they were cautiously optimistic about the availability and affordability of such therapies in future.
Self-administered drug delivery systems were also discussed in detail. Emphasising their critical role in emergencies and chronic conditions, the panelists analysed their potential to improve patient adherence and optimise dosage. They also looked at challenges to be tackled such as regulatory challenges and the need for robust system design to improve their efficacy and effectiveness.
Inhalation drug delivery systems were also explored by the panelists who noted their evolution and potential of targeted delivery. They discussed how
L-R: Dr Sandhya Shenoy,Associate VP-R&D - Formulation,IPCALaboratories; Vinod Arora,Principal Advisor,IGMPI (MODERATOR); Dr Rakesh Kumar Bhasin,Head R&D (Formulations),Biocon; Mathivanan Rajagopal,VPand Head - R&D,Axxlent Pharma Science; Mahesh Gavasane,GM and Head of Downstream and Formulation,BSV; Dr SajeevChandran,VP-Pharma R&D,Lupin; Dr Anil Kumar R,Sr VP-R&D & MSAT,Strides Pharma
KEYTAKEAWAYS
◆ We are witnessing a lot of progress in drug deliverydriven bypatient needs,advancements in science and technologyand ease of use
◆ Self administered drug deliveryis an evolving segment.Though there are significant regulatoryand compatibilitychallenges in their development,these systems such as prefilled syringes and autoinjectors are vital for emergencies and chronic conditions
◆ Inhalation drug deliverysystems offer more targeted delivery,are non-invasive and more patient-centric.We are seeing a lot of research on these systems,especiallyfor vaccines and biologics.
◆ Topical formulations are non-invasive,decreases dosing frequency,reduces drug toxicityand improves patient compliance. However,development of topical drugs are challenging as skin is a major barrier for entryof drugs into the bodyand several physicochemical parameters need to be considered
◆ Depot injections allowslowrelease of the drug into the body,over weeks or even months and thus help patients to reduce frequencyof medication.Theycan be supplied in vials,dual cartridge systems or pre filled syringes.However,challenges in developing them include establishing bioequivalence and heat sensitivity.
◆ Implants can control drug release,reduce side effects,and improve safetyand efficacyof treatment.Theyare finding increased application across various therapeutics areas.
inhalation drug delivery is a combination of patient centricity, formulation factors, and the device. They also noted that significant research is underway on these systems, particularly for vaccines and biologics.
The discussion covered topical drug delivery systems where formulation sta-
bility and process optimisation are crucial for ensuring consistency and clinical efficacy. Panelists are hopeful that future advancements will improve these aspects.
Lastly, the experts examined how implants are a growing market due to their ability to control drug release and improve treatment safety and efficacy.
The panel touched upon developmental challenges faced within India’s R&D landscape as well. In conclusion, the panel discussion underscored the dynamic evolution of drug delivery systems, their transformative potential in the pharmaceutical industry and the way forward for progress in this ever evolving segment.
Process development and optimisation
In a presentation at FDD Conclave 2024, Prashant Deshpande, Head of Process Technology & Support at ACG, highlighted the significance of process development and optimisation in the pharma industry. The session focused on enhancing production processes to ensure efficiency, quality, and cost-effectiveness.
Deshpande explained that the development stage is where thorough assessments are conducted using design of experiments, risk-based matrices, and statistical analysis. Regulatory guidelines from authorities like the USFDA, EMA, ICH, and WHO underscore the importance of process development and optimisation to ensure product quality, safety, and efficacy.
He explained that process optimisation at the production site focuses on reducing manufacturing costs, increasing production efficiency, and improving product quality. This phase includes scalable production, faster time to market, and optimal resource allocation.
He also highlighted the difference between process qualification and validation in maintaining the quality and relia-
bility of pharma manufacturing. Qualification focuses on equipment and process performance, while validation ensures consistent product quality throughout the lifecycle.
He explained that sampling also plays a vital role in process develop-
ment, ensuring accurate representation of batches. Quality control through sampling and testing helps monitor and maintain product standards, stated Deshpande.
He also informed that ACG Laboratories at Shirwal offers extensive sup-
Process development is crucial alongside formulation for large-scale drug production
port for development, scaling up, and regulatory compliance. The facility enables product testing, development, and optimisation using pilot-scale machinery. Additionally, ACG provides regulatory support and training sessions, facilitating efficient technology transfer for streamlined manufacturing processes.
In this presentation, Deshpande assured the audience about ACG's commitment to advancing pharma manufacturing through innovative process development and optimisation strategies.
Exploring advancements in extractables and leachables (E&L) sterilisation and glassware washing
India’s pharma landscape is evolving rapidly and the allied sector has to match this pace with the help of emerging technologies and innovative solutions. So, Stinita Dsouza, Application Specialist, Equitron Medica gave a presentation on latest advancements in sterilisation and glassware washing and their impact on quality and safety standards. She highlighted how steam sterilisation can have mechanical and chemical properties, and result in leachables from plastic and elastomers, which present a need for adaptable steam sterilisation equipment.
She also informed that Equitron offers the autoclave STELLA for E&L that provides EP and USP-compliant cycles for glass, plastic and elastomer. It offers several cycles and optimal sterilisation due to suitable
She explained that Equitron offers standard and GMP glassware washers. They provide customisable shelves to fit various sizes of glassware with optimal and compact loading accessories, resulting in fewer wash cycles. The washers have an intuitive configuration of wash cycles and a HEPA filter for drying. With their products, Equitron aims to serve applications of microbiology quality control, organic chemistry R&D and healthcare pathology.
She concluded that Equitron's autoclaves comes with several advantageous features like front-size serviceability, compact design, water conservation, EU Pressure Equipment Directive (PED) certification and automated corrective action on power failure.
Future trends in excipients with lownitrite
In a recent presentation, Ravleen Singh Khurana, MD of Nitika Pharmaceuticals Specialties, discussed the impact of excipient selection on nitrosamine formation in drug products. Managing nitrosamine impurities is a significant challenge in the pharma industry, as nitrosamines can form during manufacturing and storage through the reaction of nitrites with amine-containing APIs or impurities.
The presentation highlighted that nitrite levels in excipients like microcrystalline cellulose (MCC), lactose, and superdisintegrants significantly influence nitrosamine formation. High nitrite levels can increase nitrosamine formation by up to 151 per cent. Changing the supplier of MCC or other critical excipients can reduce nitrosamine levels by up to 89 per cent. Lhasa's database provides validated data on nitrite levels in excipients, aiding in risk assessment. This resource helps pharma companies manage the variability in nitrite levels across different excipient types and suppliers.
maceuticals offers products such as MCC, magnesium stearate, and sodium stearyl fumarate with low nitrite levels. These excipients are part of a strategy to mitigate nitrosamine risk and enhance patient safety.
Variations in excipients like MCC,lactose,and superdisintegrants affect nitrosamine formation in formulations. Lhasa’s database provides validated data on nitrite levels in excipients to aid in risk assessment
He also emphasised the importance of selecting low-nitrite excipients to reduce the risk of nitrosamine formation and improve product safety. This approach is crucial for high-risk formulations and aligns with regulatory guidelines to ensure the safety and efficacy of pharma products.
Patient-centric dosage forms: ORO-dispersible films
Innovative formulations are reshaping pharma delivery for improved patient convenience and adherence. informed Dr Suruchi Vishwasrao, Sr Scientist, Merck Life Sciences, as she explained the need for patient-centric dosage forms.
She explained that ORO offers ease of administration and faster disintegration. Polyvinyl alcohol supports consistent final product quality and QbD and provides highly adaptable solutions and batch-to-batch consistency. Polyvinyl alcohol when processed through hot melt extrusion, disperses the API with a matrix polymer, helping to increase the dissolution rate and improving the solubility for poorly soluble APIs.
She also informed that Merck offers Parteck MXP 4-88 with improved thermostability and Parteck MXP3-82 with improved hydrophobic interactions. The polymers provide the benefits of enhanced solubility, high drug loadings, stable amorphous solid dispersion, applicable to a broad range of APIs, and have optimised powder properties.
They are multi-compendial and EM-
Dr Suruchi Vishwasrao,Sr Scientist,MerckLife Sciences
Parteck MXP4-88 and Parteck MXP382 polymers, produced via hot melt extrusion technology, enables smooth processibility and forms homogeneous orodispersible films along with plasticizers
PROVE grade that support reliable reproducibility of quality and performance of the final drug product.
Panel discussion: Fostering meaningful collaborations in pharma R&D
The last panel discussion of Day 1 of FDD Conclave 2024 deepdived into the vital role of strategic collaborations in advancing pharma R&D. The panel, moderated by Dr Ashok Omray, Pharma Consultant, also comprised Satish Upadhyay, Associate President, Mankind; Dr Sumedha Nadkar, Pharmaceutical Consultant and NMIMS - Visiting Faculty Quality and Regulatory Affairs; Suresh Pareek, Angel Investor; Makarand Avachat, Executive VP- Pharma R&D, Lupin; Prashant Deshpande, Head, Process Technology & Support, ACG; Dr Praveen Khullar, Executive Director, VerGo Pharma; and Dr Girish Jain, Pharma Consultant.
The panel of experts explored various aspects of R&D partnerships and underscored their role in overcoming high costs and complexities of pharma R&D. Good collaborations enable faster scientific breakthroughs and address complex healthcare challenges more effectively by pooling knowledge, resources, and expertise, emphasised the panellists.
The discussion also addressed the importance of industry-academia collaborations and hand-holding to accelerate progress in pharma R&D. One of the recommendations by the panel was building Centres of Excellence (CoE), where industry professionals could serve as visiting faculty, bringing current knowledge to the students making them industry-ready.
The experts suggested that these CoEs can be called "Centres of Skill Development" and funding can come from CSR programmes of companies. They unanimously agreed that such centres could provide research facilities with equipment, infrastructure, and funding from CSR and industry partnerships. This creates an ecosystem where pharma graduates receive training and stipends, and the resources and manpower costs are shared.
The discussion also drew attention to the role and significance of industryto-industry collaborations to strengthen India’s position against global competitors. But the experts also acknowledged that complexities and challenges such as confidentiality and profit sharing exist and they need
Dr AshokOmray,Pharma Consultant
Dr Praveen Khullar,Executive Director,VerGo Pharma; Suresh Pareek,Angel Investor (Pharma); Dr Sumedha Nadkar,Pharmaceutical Consultant and NMIMS - Visiting FacultyQuality& RegulatoryAffairs; Dr Girish Jain, Pharma Consultant; Satish Upadhyay,Associate,President,Mankind; Prashant Deshpande,Head,Process Technology& Support,ACG; Makarand Avachat,Executive VP- Pharma R&D,Lupin
KEYTAKEAWAYS
◆ Strategic collaborations can help create and sustain an ecosystem that spurs innovation,encourages knowledge sharing, and strives to meet underserved needs
◆ Industry-academia partnerships can usher pivotal benefits including skill development,job creation,faster scientific breakthroughs,and the development of innovative products and solutions
◆ Effective industry-industrytie-ups can lead to shared expertise and resources,reduced financial risks,increased access to newtechnologies,enhanced market access and improved regulatorycompliance
◆ India's pharma industryshould embrace a mindset that is open to newideas and alliances with diverse industries to unlock innovation,gain novel insights and adopt effective approaches to deal with its challenges
◆ Trust,common values,complementing strengths and a clear vision are vital to make partnerships successful in pharma
to be tackled with the help of effective strategies.
Building relationships with local vendors and integrating interdisciplinary collaborations with IT solutions were also highlighted by the panel. These partnerships can lead to innovative solutions and improved logistics, driving
further advancements in formulation development and drug delivery.
A strong message was that fruitful partnerships need a robust foundation built with shared values, a common vision, transparent communication, effective processes and complementary individual strengths. These elements
are vital in building trust and ensuring the success of collaborative efforts.
Thus, the discussion provided valuable insights into how strategic collaborations can drive innovation, skill development, and growth to achieve collective goals and advance human health.
L-R:
(MODERATOR);
Panel discussion: Tech revolution in FR&D
Day 2 of FDD Conclave 2024 commenced with an insightful panel discussion on "Tech revolution in FR&D." that explored the impact of emerging technologies on formulation R&D.
The discussion, moderated by Dr Pirthipal Singh, VP & Head of R&D at Tirupati Group, brought together esteemed experts including Dr Madhusudan Bommagani, President R&D Formulation, Cadila Pharmaceuticals; Amarender Reddy Donthidi, VP & Head of R&D Injectables and Ophthalmics, Amneal Pharmaceuticals; Sachin Arora, VP & Delivery ManagerFormulation Development, Dr Reddy's Laboratories; Dr Balasubramaniam Jagadish, VP-Formulation Development, Recipharm Pharmaservices; and Dr Pavan Bhat, Executive Director, Natco Pharma.
The panel highlighted the critical role of AI in drug discovery and development, emphasising how AI-driven predictive modeling and machine learning algorithms are accelerating drug development processes.
The discussion also examined significant strides in technology adoption over the past five to six years, with major pharma companies investing in AI for innovation, efficiency, decisionmaking, and product quality enhancement. It also underscored the importance of leveraging predictive tools and analytics to gain crucial data insights and address R&D and manufacturing challenges.
The panel conversed and conferred over the impact and potential of AI/ML and other emerging technologies to optimise formulation development, gain faster regulatory approval and market drugs faster. However, allaying certain fears, they opined that these technologies will complement, not replace, human expertise. By integrating AI and data analytics, scientists can enhance precision, reduce errors, and foster innovation without losing the invaluable human touch.
They also cited some real-life examples to prove their points. For instance, using AI-driven drug excipient databases to accelerate drug development with better quality control by predicting and eliminating drug toxicity.
The panel also admitted that the adoption of emerging technologies, despite their huge potential, is slow in
L-R: Dr Pirthipal Singh,VP& Head - R&D,Tirupati Group (MODERATOR); Dr Madhusudan Bommagani,President - R&D Formulation,Cadila Pharmaceuticals; Amarender ReddyDonthidi,VP& Head - R&D Injectables and Ophthalmics,Amneal Pharmaceuticals; Sachin Arora,VP& DeliveryManager-Formulation Development-Oral Solids - US,EU,CA& Global Markets,Dr Reddy's Laboratories; Dr Balasubramaniam Jagadish,VP- Formulation Development (PDU),Recipharm Pharmaservices; Dr Pavan Bhat,Director and Executive VP(Technical Operations),Natco Pharma
KEYTAKEAWAYS
◆ Pharma R&D generates a lot of useful data.Deploying data analytics and predictive tools can help identifyoverlooked patterns to gain crucial insights and drive meaningful outcomes
◆ AI is crucial in pharma,from drug discoveryto data science and machine learning.Data sciences integrate AI into systems to gain meaningful information.AI helps optimise processes,minimise manual errors,improve qualitycontrol,and ensure better product delivery
◆ Drug excipient database developed with AI can aid FR&D scientists to increase the pace of drug development.
◆ The pharma industryhas made significant strides in technologyadoption over the past five -sixyears.Major companies like Lupin,Cipla,and Reddy’s are investing heavilyin AI for innovation,improved efficiencydecision-making and enhanced product quality.
◆ The generic industrycan adopt AI through collaboration and data sharing,using predictive tools to analyse data and solve R&D and manufacturing issues.
◆ AI rationalises formulation processes but faces challenges in customer experience and process efficiency.Scientists can leverage AI tools,data analytics and machine learning to gain pivotal benefits without replacing human expertise
India’s pharma sector. Cost, resistant mindsets, inadequate skill sets are some reasons hindering large scale implementation of these technologies.
However, they acknowledged that AI, big data analytics and other emerging technologies will be key drivers of innovation and efficiency in pharma
R&D in the future. The session proved to be enlightening and thought-provoking with several takeaways for the FR&D fraternity.
Panel discussion: Forging the path for tomorrow's therapeutics
The final session on Day 2 of FDD Conclave 2024 was an engaging panel discussion on ‘Forging the path for tomorrow's therapeutics: Opportunities & Challenges’.
In this session, experts delved into the opportunities and challenges in developing tomorrow's therapeutics and examined vital topics like targeted delivery, bioavailability enhancement, and scalability from lab to market. This discussion also addressed changing patient needs, strategies to stay competitive in a dynamic market, and addressed some ever-evolving challenges in the pharma landscape.
The panelists for this discussion were Birendra David, VP, Delivery ManagerInhalation and Head-Process Engineering,Dr. Reddy's Laboratories (Moderator); Dr Shubhadeep Sinha, Sr VP, Head of Clinical Development & Medical Affairs at Hetero Labs; Elayaraja Natarajan, VP of R&D, Lyrus Life Sciences; Dr Tausif Ahmed, VP and Head-Biopharmaceutics & Bioequivalence, Dr Reddy's Laboratories; Dr Vasanthakumar Ramu, VP, Head of R&D - Peptides & Complex APIs, Alembic Pharmaceuticals and Iranna Bavalatti, VP & Head Technology Transfer, Maiva Pharma.
The discussion touched upon several key aspects including targeted delivery, bioavailability enhancement, and scalability from lab to market.
It highlighted how AI-driven solutions can streamline important processes and functions such as establishing bioequivalence, regulatory processes in clinical stages, ensuring data integrity and reducing approval times.
The panel of experts also emphasised the need for clear roles and responsibilities and effective communication in bridging the gap between R&D, manufacturing, and supply chain within pharma organisations to drive effective and faster outcomes.
A key focus of the discussion was on advancements and challenges in peptide drug development. The panelists discussed and debated on the advantages, progress and application of peptide drugs and acknowledged that it remains a highly technical and time-consuming process. Automation was identified as a critical tool to overcome these challenges.
L-R: Birendra David,VP,DeliveryManager-Inhalation and Head- Process Engineering,Dr Reddy's Laboratories (MODERATOR); Dr Shubhadeep Sinha,Sr VP,Head - Clinical Development & Medical Affairs (CD&MA) Hetero Labs; Dr Tausif Ahmed,VPand Head-Biopharmaceutics,Preclin and Clinical Bioanal,Global Clinical Management,Dr.Reddy's Laboratories; Dr Vasanthakumar Ramu,VP,Head of R&D - Peptides & Complex APIs,Alembic Pharmaceuticals; Iranna Bavalatti,VP& Head TechnologyTransfer,Maiva Pharma
KEYTAKEAWAYS
◆ Leveraging learnings from preclinical studies such as virtual bioequivalence through AI driven solutions can streamline regulatoryprocesses in clinical stages,ensuring data integrityand cutting down on approval times.
◆ Clear roles and responsibilities and precise communication will help bridge the gap between R&D,manufacturing and supply chain,and aid the process of tech transfer,making it effective and faster
◆ Peptides drug development has seen significant progress.However,it is highlytechnical,and time-consuming,involving multiple challenges including extensive testing and impuritymanagement.Hence,automating is the need of the hour
◆ QbD,novel deliverystrategies,emerging technologies like AI are aiding advancements in peptides drug development.For example,predicting immunogenicityriskwith in silico tools,identifying nitrosamine impurities in peptides drug development etc
◆ Patient needs will drive therapies of the future.It will involve patient-centric approaches to clinical trials,use of technology such as AI and automation to improve convenience for patients and boost health outcomes.
They also informed that use of Quality by Design (QbD), novel delivery strategies, and emerging technologies like AI are aiding advancements in peptide drug development. For instance, use of insilico tools to predict immunogenicity risk and identify nitrosamine impurities in peptide drugs.
Agreeing that patient needs will be paramount in driving the therapies of the future, the panel was emphatic that this will necessitate adopting patient-centric approaches to clinical trials and leveraging technology such as AI and automation to
enhance patient convenience and health outcomes.
In conclusion, the session provided valuable insights into driving innovation within the pharma research and development landscape.
FDD Leadership Awards 2024 honours FR&D heroes
13 R&D professionals were honoured for their significant committment and contribution towards innovation and excellence in formulation development and drug delivery across three categories: Stalwarts,Leaders,and Rising Stars
The sixth edition of the FDD Leadership Awards, held at Novotel Airport, Hyderabad, celebrated 13 outstanding R&D leaders whose innovations and contributions have significantly advanced the fields of formulation development and drug delivery. Express Pharma, with Cilicant as the Presenting Sponsor, hosted the prestigious event.
The evening commenced with an insightlful Address by the Chief Guest for thevening, K Raja Bhanu, Director General, Pharmexcil. Spotlighting how India has solidified its reputation as the "Pharmacy of the World," driven by its ability to deliver quality and affordable medicines, he emphasised that India's pharma industry is now expanding its global capabilities beyond generics to include biosimilars, biological entities, and complex generics. However, with rising competition from neighboring countries, it is imperative for India to optimise its existing strengths and mitigate limitations through the adoption of new technologies. This strategic focus will be crucial for maintaining and enhancing its leadership position in the global pharma market.
Next, Viveka Roychowdhury, Editor of Express Pharma, welcomed attendees and emphasised the importance of recognising the achievements of FR&D
WINNERS OF FDD LEADERSHIPAWARDS 2024
Category: Stalwarts
✰ Mr Satish Chandra Upadhyay
Category: Leaders
✰ Mr AlokRanjan Samal
✰ Dr Balasubramaniam Jagdish
✰ Mr Elayaraja Natarajan
✰ Dr Girish S Achliya
✰ Dr Pirthipal Singh
✰ Dr SajeevChandran
✰ Dr Satish Patil
✰ Dr Saurabh Gupta
Category: Rising Stars
✰ Dr Ganesh Shete
✰ Dr Punit Shah
✰ Dr Pradeep Kumar
Vishwakarma
✰ Mr Vipul Mittal
leaders in an ever-evolving industry. She detailed the stringent selection process of the FDD Leadership Awards, which ensures that only the most deserving candidates are honored. Lauding all winners, she said, “On behalf of The In-
dian Express Group and Express Pharma and the Jury Members, congratulations to the winners, do continue with your good work. We hope these Awards will go a long way to spotlight the innovative work you do and help elevate the standing of FR&D in your company and within the larger FR&D fraternity.”
A distinguished jury, comprising pharma veteran Dr Kour Chand Jindal,
Suresh Pareek, Angel Investor (Pharma), Dr Sumedha Nadkar, Pharmaceutical Consultant and NMIMSVisiting Faculty Quality & Regulatory Affairs, Dr Veerbabu Taduri, Ex-VP R&D-Formulations at Alembic Pharmaceuticals and Abha Pant, Pharma Consultant, played a crucial role in selecting the winners.
Hence, Roychoudhury's address was followed by the felicitation of the
All winners of FDD Conclave 2024
KRaja Bhanu,Director General,Pharmexcil
esteemed jury members who attended the event - Dr KC Jindal, Mr Suresh Pareek and Dr Sumedha Nadkar.
Next,13 FR&D professionals were honoured for their significant contributions to FR&D across three categories: Stalwarts, Leaders, and Rising Stars.
The winners are as follows:
The jury members present also joined Roychowdhury, Manish Jain, MD and CEO of Cilicant, and the Chief Guest Raja Bhanu in presenting the awards.
After the awards presentation, a
hilarious and energetic stand-up comedy act added an extra dose of joy to the evening! Sai Kiran, a renowned stand up comedian regaled the audience with a fun-filled performance.
The night concluded with a networking gala dinner, providing an excellent
opportunity for attendees to connect and exchange ideas.
The FDD Leadership Awards 2024 was a celebration of the leaders driving progress in FR&D and their commitment to innovation and excellence in the pharma sector.
Winners in the Leaders Category
VL-R: iveka Roychowdhury,Dr Sumedha Nadkar,Suresh Pareekand Dr KC Jindal
Winners of the Rising Stars Category
Winner of the Stalwarts Category Stand-up comedian Sai Kiran,performing at FDDLeadership Awards 2024
FDD CONCLAVE 2024
FDD CONCLAVE 2024
FDD CONCLAVE 2024
FDD CONCLAVE 2024
STRATEGY
Indian biotech start-ups: Need for pragmatic,
pro-active,progressive
regulatorymilieu
Dr Arun Bhatt,Consultant – Clinical Research and Drug Development highlights that the Indian biotech startup sector has surged in the post-COVID era,driven by innovative healthcare product development.He also explores the regulatory challenges faced by bio-entrepreneurs and suggests pragmatic approaches to streamline their path to market success
Indian biotech startup sector - a rapidly growing business segment - has expanded tremendously in postCovid era. The biotech startups aim to develop innovative health care products, which have huge potential to make substantial contributions to Indian economy. During Covid-19 pandemic, fast regulatory approval process to meet the urgent medical need benefited the bio-entrepreneurs. Recent initiatives of the Indian government have encouraged many academicians, scientists, and technocrats to become entrepreneurs. They expect swift regulatory approvals, which can facilitate fast entry in the market and can accelerate the journey from startup to unicorn. This brief review discusses regulatory challenges faced by Indian bio-entrepreneurs and suggests pragmatic regulatory approaches to ease their burden.
Start-up strategyfor success
The founders of start-ups are mostly academic basic scientists, who have innovative product ideas, but are not experienced in clinical trials for product development and regulatory approval of products for marketing. They have limited funds, which are dependent on achieving important product development milestones. Hence, they are focussed on rapid completion of development of products which can move quickly from bench to bedside. The Indian regulatory environment would appear very demanding to these entrepreneurs.
Indian regulatory intricacies
Central drugs Standard Control Organisation (CDSCO) has the primary responsibility and authority for regulation of products. Other government organisations e.g. Department of Biotechnology or Indian Council of Medical Reasearch (ICMR) have an advisory role for certain product categories. The regulatory system is based on New Drugs and Clinical Trials Rules (NDCTR) 2019, guidelines, processes, checklists, and review by advisory committees. The rules are often amended through Gazette Notifications.
Bio-entrepreneurs are interested in developing diversity of new health care products based on new sources or new targets or new formulations. The spectrum of such product includes: new chemical entity (NCE), new drugs with new indication or new route of administration or new dosage form, modified or sustained release formulations, novel drug delivery forms, vaccines, medical devices, and in-vitro diagnostic medical devices. The clinical development and regulatory approval requirements would be different for each of these products. However, the CDSCO website, which is the main source of regulatory information, does not provide guidance on regulatory requirements for specific state-of-the-art innovator products or links to relevant info available on the other government department websites. Divergent regulatory requirements between NDCTR 2019 and Medical Device Rules 2017; between NDCTR 2019 and biologics guidelines; and need for animal studies for approved new drugs with modi-
fied or new claims would make regulatory process time consuming and costly for a startup. This scenario may make startup company explore countries like Australia or Canada for clinical trials, which have less cumbersome regulatory approval process.
Rationalising regulatory requirements
Internationally, health authorities play an active role in guiding bio-entrepreneurs in navigating the regulatory path.
US Food and Drug Administration’s Center for Drug Evaluation and Research’s (CDER) Small Business and Industry Assistance (SBIA) helps industry stake-holders immediate access to resources, education and training to support them in planning efficient developmental process. CDER’s Pre-Submission program allows the start-ups to obtain FDA's feedback on specific questions to guide product development or application preparation. FDA had also planned a conference on innovation in Medical Product Development Regulatory Education for Industry (REdI) which included:
1) Drug track to address ma-
jor advances and innovation across various aspects of the drug development spectrum,
2) Devices track to provide an overview of marketing approval and best practices for quality, safety and effectiveness and
3) Biologics track to focus on the product development approach for vaccines, and other biological products.
European Medicines Agency (EMA) offers advice to micro, small and medium sized enterprise (SME) about regulatory requirements by phone or email. SMEs can also meet the EMA team to discuss regulatory strategy for product development and understand available procedures, guidance, and incentives.
ICMR and CDSCO’s MedTech Mitra is a laudable initiative that aims to foster development of affordable and accessible indigenous medical devices/ In-vitro diagnostics by providing strategic handholding support to MedTech innovators for clinical evaluation, regulatory facilitation and uptake of new products through consultation meetings for innovators. MedTech Mitra website (medtechmitra.icmr.org.in) has details of Clinical Investigation Centres - Indian Clinical Trial and Education Network (INTENT) and Clinical Performance Evaluation Centres. A Public Relations Officer has been deputed by CDSCO to provide information to bio-entrepreneurs regarding regulatory requirements for commercialisation of their products. However, the bio-entrepreneurs working on state-of-theart new drugs, medical devices, in-vitro diagnostic tests, and biologics would wonder whether
such regulatory advice would be helpful in developing international standard products. There is an urgent need for Indian health authorities to take major initiatives to help this budding industry.
Some useful approaches could be:
◆ Special division within CDSCO targeted on specific requirements of bio-entrepreneurs
◆ User friendly website with comprehensive information for diversity of healthcare products
◆ User guide describing overview of procedures to support product specific IND and NDA processes
◆ Guidelines and decision tree flow-charts to educate the bioentrepreneurs about regulatory expectation of non-clinical and clinical development requirements especially for new drugs with new claims or modifications
◆ Create awareness amongst advisory committees and regulatory officers about unique needs of bio-entrepreneurs
◆ Pragmatic approach in review of regulatory documentation tailored to development of specific products
◆ Formal written regulatory advice after regulatory consultation meetings or email queries on regulatory strategy questions from bio-entrepreneurs
Indian innovators, who are creating innovative health care products, would play a vital role in fulfilling unmet medical needs of patients of today and of future. They expect the Indian health authorities to facilitate their product development journey in becoming Atmanirbhar!
The company's dock levelers are designed and manufactured to bridge the gap between the factory floor (dock) and the vehicle,guaranteeing the safe,secure,and smooth transfer of goods
Gandhi Automation provides a wide range of dock levelers (dock leveller) to streamline the loading and unloading process. The company's dock levelers are designed and manufactured to bridge the gap between the factory floor (dock) and the vehicle, guaranteeing the safe, secure, and smooth transfer of goods.
Technical Specifications
All types of dock levelers –Swing Hinged Lip, Telescopic Lip Dock Leveler, Vertical Storing Dock Leveler with ElectroHydraulic, Pneumatic (Air Bag), and Manual Operation.
◆ Load capacity: Standard load capacities of 6000 kg (6 tons) to 25000 kg (25 tons), making them suitable for heavy-duty operations
◆ Material: Built from highstrength structural steel (S355), with options for hot-dip
Gandhi Automation provides all types of dock levelers –Swing Hinged Lip,Telescopic Lip Dock Leveler, Vertical Storing Dock Leveler with ElectroHydraulic, Pneumatic (Air Bag), and Manual Operation
galvanised finishing or stainless steel 304 and 316 grades for use in coastal environments
Benefits of Gandhi Automation DockLevelers
◆ Enhanced safety: Our dock levelers comply with EN 1398 standards, ensuring maximum safety for operators.
◆ Durability and maintenance: Built with high-quality materials and innovative designs, our dock levelers require minimal maintenance, ensuring long-term reliability.
◆ Its platform is welded using robotic arm and lip in almond anti-slip steel
◆ Single effect lift cylinder, double effect lip cylinder
◆ Maintenance prop to support Dock Leveler during maintenance checks
Titrator Excellence T5: Versatile titrator for all applications
The Titration Excellence T5 from METTLER TOLEDO is a highly versatile instrument designed for a wide range of titration applications, offering unmatched flexibility, expandability, and user-friendly features. It supports both potentiometric titration and Karl Fischer titration, making it suitable for various sample types, from acid-base titrations to moisture content determination. The T5 can be customised to meet specific requirements, starting with a basic configuration and expanding up to four burettes, thus allowing laboratories to adapt the instrument as their needs evolve.
The T5's automation capabilities, supported by InMotion automation, streamline repetitive tasks and enhance efficiency in handling large sample volumes or routine analyses. It features userfriendly elements like oneclick titration, which automates multiple steps with a single click, and plug-and-play sensor recognition that reduces setup time by automatically recognising sensors. The method database allows for
CONTRIBUTOR’S CHECKLIST
easy storage and management of titration methods, ensuring quick retrieval and consistency in operations.
The T5's modular design includes interchangeable boards, such as a pH board that can be exchanged for a conductivity board or a KF coulometer board, providing the flexibility to switch between different measurement techniques. Additionally, it offers robust user management features for secure access and traceability, and modern in-
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❒ Express Pharma's prime audience is senior management and pharma professionals in the industry.Editorial material addressing this audience would be given preference.
❒ The articles should cover technology and policy trends and business related discussions.
❒ Articles for columns should talk about concepts or trends without being too company or product specific.
❒ Article length for regular columns: Between 12001500 words.These should be accompanied by diagrams,illustrations,tables and photographs, wherever relevant.
terfaces, including USB, Ethernet, and CAN-Bus, enable seamless connectivity and data transfer. These features make the Titration Excellence T5 an essential tool for laboratories aiming for high efficiency, accuracy, and adaptability in their titration processes.
The T5 Excellence titrator delivers full flexibility for both potentiometric and Karl Fischer applications. Expandable from 1 to 4 total burettes to grow with advanced needs.
Supports InMotion automation for high throughput testing.
Features
◆ One click user interfaceWith the intuitive One Click touchscreen interface, customise home screens to run your workflows quickly and easily with a single tap on the screen.
◆ Fully flexible automationCompatible with powerful InMotion automation. Sample changing, complex titrations, cleaning steps and more run automatically, saving operators' time.
◆ Solid compliance - In regulated environments, LabX software provides full support for your compliance needs to 21 CFR Part 11 and EU Annex 11.
◆ Plug and play accessoriesSensors and burettes are automatically recognised when connected. Avoid errors by eliminating extra data entry steps and reduce instrument setup time.
◆ Karl Fischer titrationExcellence line titrators fully support both volumetric and
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❒ Besides the regular columns,each issue will have a special focus on a specific topic of relevance to the Indian market.
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Email your contribution to: The Editor, Express Pharma, Business Publications Division,
coulometric Karl Fischer titrations to accurately measure water in liquid or solid samples from 0.001% to 100%.
◆ Automated workflows for traceability - Data entry options include barcodes and RFID tags to instantly transfer sample IDs, weights, and chemical information, even automatically choosing the correct method for every sample.
◆ Safe chemical handlingReduce user contact with chemicals by automatically draining and refilling the titrator cell and p reventing waste overflow with dedicated accessories.
◆ SmartChemicals - The SmartChemicals accessory enables instant wireless transfer of titration chemicals' identity and shelf-life data to the titrator. No mistakes or wasted operator time.
For more information, visit: Titrators, Autosamplers, Accessories & More | METTLER TOLEDO (mt.com) Email us at –sales.sales@mt.com Call us toll-free at – 1800 22 8884 & 1800 1028 460
The Indian Express (P) Ltd, Mafatlal Centre,7th floor, Ramnath Goenka Marg, Nariman Point,Mumbai 400021 viveka.r@expressindia.com viveka.roy3@gmail.com
PHARMA PULSE
Imafit: Platinum cured silicone hose with polyester braiding
Imafit from Ami Polymer has excellent flexibility for pressurised fluid transfer application in pharma and biotech industries
Imafit is platinum cured grade silicone hose reinforced with polyester braiding. Before going into silicone hose first, we took a glimpse of Silicone tube.
Silicone tubes are commonly used in the pharmaceutical industry due to their inertness, flexibility, and resistance to extreme temperatures. These tubes are often employed in various applications such as fluid transfer, drug delivery systems, peristaltic pumping, and laboratory equipment. Imafit™ is Platinum cured Silicone hose reinforced with Polyester braiding. It has excellent flexibility for pressurized fluid transfer application in pharmaceutical and Biotech Industries. We are catering these products to all pharma and biotech companies in India and Overseas. Imafit™ hose is manufactured under stringent quality parameters to have greater flexibility and minimum bend radius. IMAfit Silicone hoses are flexible tubes made from silicone rubber. IMAFit silicone hoses offer a combination of temperature resistance, flexibility, chemical resistance, and biocompatibility and many more features making them versatile and widely used in various industrial and commercial applications.
KeyFeatures of IMAFit
1. Temperature Resistance: IMAfit silicone hose can withstand extreme temperatures, ranging from -80°C to 180°C. This makes them suitable for applications where exposure to high or low temperatures is common, such as automotive engines, industrial processes, and food processing.
2. Flexibility: IMAfit silicone hose are highly flexible and can be bent and twisted without kinking or collapsing. This flexibility allows them to be easily routed around obstacles and through tight spaces, making
them ideal for complex piping systems.
3. Chemical Resistance: IMAfit silicone hose exhibit excellent resistance to a wide range of chemicals, including acids, alkalis, and solvents. This property makes them suitable for use in chemical processing, laboratory equipment, and pharmaceutical manufacturing.
4. Biocompatibility: IMAfit silicone hose is biocompatible and non-toxic, making silicone hoses safe for use in medical devices, pharmaceutical applications, and food and beverage processing.
5. Hygienic Properties: IMAfit silicone hose are easy to
clean and sterilize, making them suitable for use in sanitary applications where cleanliness is critical, such as food and beverage processing and pharmaceutical manufacturing.
6. Custom color-coding available: IMAfit silicone hose available with facilities of Color-coding, which can serve several purposes like Identification, organization, Safety, Aesthetic Considerations.
7. Available with SS 316 TC End: IMAfit silicone hose available with facilities of SS 316 Tri clovers end having Ra Value ? 0.5 at bore for easy connection and ensuring leak-proof transfer.
8. Nylon braiding: IMAFit silicone hose is also available in nylon braiding which can more strong and resist more heat on customer request.
IMAfit silicone hose find applications in various location, including:
◆ Pharmaceutical and biotech material transfer6
◆ Critical liquid transfer
◆ Load cell and cell cultures
◆ Analytical lab Food and beverages
◆ Biotechnology
Certification having on IMAFit Silicone Hose
◆ Conforms to US FDA 21 CFR
177.2600 Food grade Standard
SO YOU CAN REFER FOLLOWING TABLE FOR PRESSURE AND AVAILABLE OFSIZE
◆ Conforms to USP Class VI
◆ Conforms to ISO 10993-1
◆ ROHS certified, free of restricted heavy metals
◆ Free of Phthalate/ Bisphenol/ Volatile Plasticizer.
◆ TSE/BSE Certification (free of animal derived material.
◆ USFDA DMF accreditation #26201
◆ Complete Validation package available upon request
Enhancing pharma manufacturing with advanced humiditycontrol solutions
Bry-Air's desiccant dehumidifiers are designed to maintain optimal relative humidity (RH) levels that creates stable manufacturing environments regardless of external conditions
In the dynamic world of pharma, maintaining stringent quality standards and efficient manufacturing processes is essential. The control of environmental conditions, particularly humidity, plays a crucial role in ensuring product integrity throughout various stages of pharma manufacturing.
Humidity control is critical to prevent organic corrosion, biochemical reactions, and microbial growth, which can compromise the quality of pharma products. Each stage of the production process, from powder milling and tablet compression to storage and packaging, demands precise humidity management. This is where Bry-Air's cutting-edge desiccant dehumidifiers come into play.
Bry-Air's desiccant dehumidifiers are designed to maintain optimal relative humidity (RH) levels that creates stable manufacturing environments regardless of external conditions. These dehumidifiers are precision-engineered with
By leveraging Bry-Air's advanced humidity control solutions,pharma manufacturers can achieve higher standards of product quality and safety. The controlled environment facilitated by BryAir's dehumidifiers enhance the stability and efficacy of pharma products as well as support regulatory compliance
CNC technology and feature a durable powder-coated finish. The incorporation of high-performance Metal Silicate Fluted media, which is both bacteriostatic and non-toxic, ensures compliance with Good Manufacturing Practices (GMP) required in the pharma industry.
By leveraging Bry-Air's advanced humidity control solutions, pharma manufacturers can achieve higher standards of product quality and safety. The controlled environment facilitated by Bry-Air's dehumidifiers not only enhances the stability and efficacy of pharma products but also supports regulatory compliance.
As the pharma industry continues to evolve, the importance of advanced environmental control systems cannot be overstated. Bry-Air's commitment to innovation and excellence in humidity control solutions positions them as a key partner for pharma companies striving to maintain high standards and drive the development of cutting-edge therapies.
PHARMA PULSE
VIVAPUR®MCG – More than a thickener
Microcrystalline Cellulose, carboxymethylcellulose sodium, xanthan gum, tragacanth gum etc. are commonly used either alone or in combination as suspension bases. Sedimentation issues, insufficient redispersibility, caking, inhomogeneity, content uniformity are some of the challenges encountered by formulators while using these excipients.
The combination of Microcrystalline cellulose (MCC) and carboxymethylcellulose sodium (Na-CMC) is used to produce thixotropic gels suitable as suspending vehicles in pharmaceutical and cosmetic formulations. The sodium carboxymethylcellulose aids dispersion and serves as a protective colloid.1 Hydrogels formed from MCC/Na-CMC are commonly used in formulations of orally taken products and nasally dosed products. This type of hydrogel gives the required rheological characteristics because it forms a thixotropic system at a low loading, in aqueous media. The yield stress of the gel is relatively high, providing good stability with respect to maintaining the suspension of dispersed particles.
What is VIVAPUR®MCG?
VIVAPUR®MCGis a free flowing powder. After activation, MCG builds an opaquewhite dispersion which masks insoluble particles, giving the suspension a homogenous appearance. The dispersedVIVAPUR®MCGis distinguished by an odorless and tasteless, smooth but not slimy mouth feel, and handles flavors well. Upon agitation, MCG dispersions show a time-dependent decrease in viscosity and become liquid. A complete, also time-dependent, regeneration of the viscosity takes place during a subsequent rest period. 4 It is a synergistic, coprocessed composite consisting of microcrystalline cellulose (MCC), sodium carboxymethylcellulose (NaCMC). VIVAPUR®MCG is a
free flowing powder. After activation in water, it forms a shear- thinning and thixotropic dispersion.3 It is more than just a physical blend; the Na-CMC is interwoven with the microcrystalline cellulose, resulting in unique synergistic properties. The Na-CMC acts as a protective colloid to prevent the re-aggregation of the microcrystalline cellulose and ensures easy dispersibility.4
Benefits:
1) Easy handling of dry powder
2) Heat stability
3) Compatibility with a wide range of ingredients
4) Stable over a wide pH range
5) Safe for us in animal health products, pediatric suspensions, and nutraceuticals
Uses: It is a high performance stabilizer used as a suspending agent, emulsifier, opacifier and thickener for oral suspensions,
Fig.1 Effect of the concentration of different VIVAPUR® MCG types on resulting viscositydirectly after activation (30 s) and after 24 hr settling time4
Fig.2 The Gel-point occurs after a fewseconds to minutes of settling time and ensures a rapid stabilization of particles.The gel point (sol-gel transition) is defined as the intersection of modulus of viscosity(GII,dotted line) and Elasticity(GI ,solid line).Different types of VIVAPUR® MCG were measured byoscillation rheometryat a 3% w/vlevel. 4
Examples of suspensions: Trimethoprim,Bismuth subsalicylate,Paracetamol,Sulfamethoxazol,Magnesium hydroxide,Mebendazole, Veterinary: Meloxicam,Enrofloxacin,Triclabendazole,Closantel,Lufenuron,Diclazuril
The density of MCG network depends on the concentration of the applied VIVAPUR®MCG. The higher the
TABLE 1: THE AVAILABLE GRADES CAN BE DISTINGUISHED BYAVARYING ELASTICITY,VISCOSITY AND NA-CMC CONTENT 4
veterinary drenches, sprays (nasal, oral or topical sprays), reconstitutable powders, creams, gels and lotions.4
concentration, the tighter the network and the better the retention of any particulate matter, such as the API. Thus, the
required performance and viscosity can easily be adjusted by the concentration used.4
VIVAPUR® MCG keycharacteristics:
1) Influence of yield point: Typical suspension consists of undissolved API particles dispersed in a liquid. Sedimentation may occur which is accelerated by Ostwald ripening
tion rate. Nevertheless, the sedimentation rate will never become zero. The insoluble API particles will not settle down until the force of gravity operating on its mass not exceeds the liquid‘s yield point.
2) Shear Thinning VIVAPUR® MCG forms a three dimensional coherent network of insoluble fibrils. All
YIELD POINT: MINIMUM SHEAR STRESS THATIS REQUIRED TO INITIATE THE FLOW.
Fig.3 Influence of yield point - VIVAPUR® MCG
in which smaller particles with higher solubility will dissolve and recrystallize on the less soluble larger particles. This may further result in caking, insufficient redispersibility and poor content uniformity.
An increased viscosity reduces strongly the sedimenta-
API particles can be kept homogeneously within the sustaining gelled network and are prevented from settling. Upon agitation, the cellulose fibrils arrange themselves in the direction of the movement. Thereby, the network loosens up and the viscosity decreases.
PHARMA PULSE
After the agitation has stopped,VIVAPUR® MCG shows a time-depending regeneration of the gel structure (thixotropy).Full regeneration after 24 hrs
3) Thixotrophy
Benefits of using VIVAPUR® MCG
1) For ready to use suspensions
◆ Accurate dosage of oral suspensions drop-by drop
◆ Smooth and pleasant swallowing without problems
◆ Dosing without threads
◆ Not “slimy and less sticking to the oral mucose”= less aftertaste and complete swallowing
◆ Easy redispersability & homogenous appearance due to opacifying effect
2) Reconstitutable powder
No degradation of the MCG powder during storage
For reconstitutable powder for oral suspension there is requirement of yield point as API stabilization is needed for 10-14 days. VIVAPUR® MCG 611 P is quite suitable for powder for oral suspensions wherein shear thinning related benefits are achieved.
References:
1) Handbook of Pharmaceutical excipients Edition. 9 Pg no. 134135
2) Zhao.G.H., Kapur.N, Characterisation of the interactive properties of microcrystalline cellulose–carboxymethyl cellulose hydrogels (2011) International Journal of Pharmaceutics 415 (2011) 95–96
