Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi
Dr. Anurag S. Rathore is an Institute Chair Professor at the Department of Chemical Engineering, Indian Institute of Technology, Delhi, India. He is also the Coordinator for the DBT COE for Biopharmaceutical Technology. His previous roles included management positions at Amgen Inc., Thousand Oaks, California and Pharmacia Corp., St. Louis, Missouri. His areas of interest include process development, scale-up, technology transfer, process validation, biosimilars, continuous processing, medical image analysis, process analytical technology and quality by design. He has authored more than 600 publications and presentations in these areas. He is presently serving as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and Associate Editor for Journal of Chemical Technology and Biotechnology. He also serves on the Editorial Advisory Boards for Biotechnology Progress, Biotechnology Journal, Electrophoresis, BioPharm International,Journal of Chromatography B, Journal of Chromatography Open, Pharmaceutical Technology Europe, and Separation and Purification Reviews. Dr. Rathore has edited books titled Preparative Chromatography for Separation of Proteins and Peptides (2017), Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Elements of Biopharmaceutical Production (2007), Process Validation (2005), Electrokinetic Phenomena (2004), and Scale-up and Optimization in Preparative Chromatography (2003). He has a Ph.D. in Chemical Engineering from Yale University.
Topic: Technology Drivers for Implementation of QbD and PAT in Biopharmaceutical Processes
Abstract: Quality by Design (QbD) started gaining momentum in the biotech industry after publication of the FDA’s PAT - A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance1-3. While the underlying concepts are becoming clear and widely accepted, the realization that technological advancements are necessary to facilitate QbD implementation is also dawning on the industry. This talk will focus on some of the tools that play a critical role in implementation of QbD for biotech processes. Real case studies have been used to elucidate this. Tools that will be discussed include Process Analytical Technology (PAT), multivariate data analysis (MVDA), design of experiments (DOE), high throughput process development (HTPD), mechanistic modeling and computational fluid dynamics (CFD). Work on these topics that is being performed in our laboratory will be presented.
Head of Process Sciences, Biocon Biologics Limited's
Ankur Bhatnagar is serving as the Head of Process Sciences at Biocon Biologics Limited's Research and Development facility located in Bangalore. With a track record of 22 years in the industry, he possesses extensive expertise in diverse areas, including CMC (Chemistry, Manufacturing, and Controls), Process Development, Technology Transfer, Scale-up, Regulatory filings, and the establishment of teams, laboratories, and pilot plants. He holds a Master's degree in Biochemical Engineering & Biotechnology from the prestigious IIT Delhi. In addition, his pursuit of knowledge extends to business management, evident through his completion of an Executive MBA program at IIM Bangalore.
Topic: Role of cell culture media and feeds for improved Biomanufacturing for Biosimilars
Abstract: Cell Culture media and feeds have a significant contribution in influencing the quality, consistency, and cost-effectiveness of biosimilars. The media and feeds need to be optimized to provide precise nutritional requirements for robust cell growth, high protein expressions, and most importantly desired product quality. It is important to understand the intricate relationship between cell culture media components, cell metabolism, and biosimilar attributes for the development of an efficient and reliable process. The talk will cover topics like the challenges in media & feed optimization for developing processes for biosimilars, different approaches used, a few case study examples, and contributions from the media and feed suppliers.
Associate Professor at the Department of Biological Sciences and Biotechnology, ICT Mumbai
Dr. Ratnesh Jain is currently an Associate Professor at the Department of Biological Sciences and Biotechnology, ICT Mumbai. He is also heading the Bioprocess Technology course of ICT, which is inclined towards industry applicability. Dr. Jain’s research group extensively works towards developing analytical methods for protein and peptide characterization, mammalian cell culture, media, and upstream process development. He has more than 100 research publications, reviews, and book chapters. His group has presented more than 350 abstracts in various leading conferences and workshops. Dr. Jain also leads one of India's largest learning and skill development platforms “Biosimilar Workshop”. Dr. Jain is a leading consultant to the biopharmaceutical industry specifically to characterize protein aggregation and is currently supporting and providing services towards biopharmaceutical product development at the R&D stage as well as regulatory approval. Dr. Jain is also mentoring and advising multiple start-ups in the domain and encouraging entrepreneurship amongst students and professionals under Govt. promoted Innovation Ambassador program. He is also coordinating and leading upcoming Mumbai Biolcuster project, which is an accelerator and Biomanufacturing hub for bioprocessing focused startup and industry.
Topic 3: Upstream Process intensification
Abstract: The growing demand for biopharmaceuticals, especially monoclonal antibodies (mAbs), has led manufacturers to seek ways to increase production. While some are exploring newer cell engineering methods, most are focusing on refining existing processes.
In our study, we aimed to enhance mAb production by optimizing the way we feed the cells during production and assessing its impact on product quality. Initially, we conducted an in-depth analysis of the substances used during the early stages of production and how they relate to cell growth, mAb levels, and product quality. This analysis, done with sophisticated techniques, revealed potential ways to improve mAb levels and product quality.
After several experiments, we discovered that enriching the cell feed with certain compounds related to the tricarboxylic acid (TCA) cycle significantly boosted mAb production without compromising product quality. This not only increased mAb levels by 40-55% but also reduced the production of unwanted byproducts like ammonia.
Additionally, we explored alternative methods to increase mAb production in fed-batch processes. One approach involved starting with a higher density of cells at the beginning of production, which resulted in faster production but maintained quality. The other approach focused on providing more nutrients through the feed, leading to a substantial increase in mAb production. Combining both high cell density and increased nutrient supply yielded the best results, with a remarkable 158% increase in mAb production and the highest productivity.
However, it's worth noting that the proportion of a specific type of mAb decreased in the high-nutrient approach, possibly due to cellular stress from elevated ammonia levels. This highlights the need for a balanced optimization strategy that considers both high production levels and maintaining product quality.
Vice President and Head - Advanced Biotech (Biosimilar Division), Ipca Laboratories Ltd.
Sanjeev Gupta has obtained Ph.D. in Molecular Biology/Cell Line Engineering and M.Sc. in Applied Microbiology and Biotechnology. At present working as Vice President and Head, Advanced Biotech Lab (Biosimilar Division-R&D and Mfg.), Ipca Laboratories Ltd., Mumbai, India.
Dr. Gupta carries over 23 years of industrial experience and has been working since 2000 on the development of “Biosimilars” including monoclonal antibodies and other therapeutic proteins. His core expertise lies into Molecular Biology, Cell Line, Cell culture, Upstream process, Bio-analytical, Regulatory as well as Tech Transfer to the GMP for Clinical and Commercial manufacturing. He is also actively involved and contributing as a key Industry leader to re-form the new guideline in India (RCGM/CDSCO) and review committee member of BIRAC (Govt. of India). He is actively involved in dossier submission, approval and interaction with different regulatory agencies such as EMA, MHRA-UK, CDSCO and USFDA for Biosimilar launch in overseas markets.
Till date, he developed and contributed for over Fifteen (15) recombinant molecules, of which Nine (09) biosimilars are already launched in the various markets and the rest are in the developmental or clinical phase, and are expected to be launched in near future.
He delivered talks on Biosimilars in various national and international conferences organized by IBC, Terrapin, BioTrain, IMAPAC, CphI, Biopharma, Informa and UBM. He also chaired/Moderated couple of sessions in international forums/platforms for conducting the biological conferences.
He has published several Research articles (13), Book chapters (06), Magazines (06) and Patent (01) in lieu of the Biosimilar development.
During his professional tenure, he worked at various position in reputed Indian biopharmaceuticals industries such as Zydus-Ahmedabad, Wockhardt-Aurangabad, Panacea-New Delhi, Intas-Ahmedabad and at present with Ipca Laboratories, Mumbai.
Topic 4: Recent advances in Process Development and scale-up study for accelerated and affordable Biosimilar Development
Abstract: This topic highlights key developments and strategies in the field of biologics and biosimilar markets, with a focus on accelerated cell line and upstream process development. The presentation delves into innovative approaches to streamline upstream processes and facilitate efficient scale-up strategies. A case study exemplifying successful process scale-up methodologies is presented. The concept of Critical Quality Attributes (CQA) is explored in the context of ensuring optimal clone selection and process development. The presentation also underscores the integration of Process Analytical Technology (PAT), Design of Experiments (DoE), and Artificial Intelligence (AI) tools, emphasizing their implementation and the advantages they bring to biopharmaceutical production. By synthesizing these diverse elements, the presentation provides a comprehensive overview of recent advancements and practices driving progress in biologics and biosimilar research and development.
Associate Director of Sales Development (APAC), Contract Testing Services, Merck Life Science Pvt. Ltd.
Steven McDade is Associate Director of Sales Development (APAC), responsible for supporting customers on virus clearance capabilities & providing technical & regulatory support. Steven has worked in the biosafety testing field for over 23 years, 17 with the BioReliance® Contract Testing Services portfolio. He has worked in a variety of roles including Technical Sales Manager (APAC), Business Development Manager for Clearance services (EMEA & Asia) and Senior Technical Specialist for our Cell & Gene Therapy portfolio. Steven graduated with a BSc (Hons) in Microbiology from Glasgow University in 1999.
Topic 5: How will ICH Q5A (R2) affect the design of virus clearance studies?
Abstract: Since its issue in 1999, ICH Q5A(R1) has been a key guideline that has shaped the design of virus clearance studies for recombinant protein products. ICH Q5A(R2), currently in draft form, includes a number of updates that will impact the design of these studies in the future. This presentation will discuss how prior knowledge gained by the industry over the last 20+ years can potentially be applied to reduce the workload for VC projects. We will also assess the use of new technologies and how alternative virus spiking strategies can be applied to explore the performance of continuous chromatography for virus clearance.
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