There is a significant commercial opportunity for biosimilar products as blockbuster biologics lose their patent protection. Many small companies in emerging economies are seeking to exploit this opportunity. To compete effectively they must be first to market, have highly efficient manufacturing processes and minimize their development costs. It is, therefore, essential for these companies to access emerging innovations that allow process intensification. One such concept is continuous manufacturing with an upstream perfusion process and a connected, integrated continuous downstream process all the way through to drug substance production.
This webinar will present advanced process modelling techniques to show how continuous manufacturing would be the obvious choice for a small biotech company developing a biosimilar product. The evaluation takes into account not only the ability of the process to be able to produce large amounts of product to meet market demand at the desired purity but also how a detailed understanding of process economics expedites the decision-making process.
Register for this free webinar hosted by Enzene Biosciences and Sartorius Stedim Biotech to learn how advanced process modelling tools can support process design decisions during the early stage development of biosimilar products.
For those that cannot attend the live event, registrants will be informed when the webinar in available for viewing on-demand.
Himanshu Gadgil
Chief Scientific Officer, Enzene Biosciences Ltd
Himanshu Gadgil completed his Master’s Degree in Microbiology from the University of Pune and his PhD in protein purification and biochemistry from the University of Tennessee. Following post-doc positions, he joined Waters Corporation as a Senior Application Scientist before joining Amgen as a Principal Scientist.
Returning to India, Himanshi Gadgil became Senior Vice President at Intas Biopharmaceuticals where he played a leading role in gaining regulatory approval for multiple biosimilar products. He is now a whole-time director and Chief Scientific Officer at Enzene Biosciences Ltd. Dr Gadgil has authored over 20 publications and patents on CMC related aspects.
Priyanka Gupta
Global Senior Bioprocess Modelling Consultant, Sartorius Stedim Biotech
Priyanka Gupta holds Master’s degrees from both the Indian Institute of Technology, Delhi and Florida State University where she developed a novel drug delivery method for a monoclonal antibody drug. She worked at Immunex as a Process Development Engineer before joining Amgen where she focused on the development of downstream processing steps.
Priyanka Gupta joined Sartorius in 2007 as a Process Development Scientist before becoming a Process Development Consultant for India-Asia. For the past year, she has been working with biopharmaceutical customers to help with their business and cost analysis for process optimization in her role as the Global Senior Bioprocess Modelling Consultant.
- Understand the key challenges faced when developing a process for a biosimilar product
- Learn how a biosimilar company evaluates different production modes including continuous bioprocessing
- Learn how companies can use a cost modelling analysis for a detailed economic analysis of different production modes
- See the findings of the economic analysis performed by Enzene Biosciences and Sartorius Stedim Biotech
- Process Development Scientists
- Process Development Managers
- Process Engineers
- Engineering Directors
- VP Operations
- VP Engineering
- VP Process Development
