Abstract:
With several approvals in the last decade, Biosimilar industry has been gaining a lot of attention as well as scrutiny by the health agencies. The correct design, development and manufacturing of a biosimilar is key to its eventual success. While it is important to adequately address the quality aspects of the proposed biosimilar, it is equally important give enough considerations to cost of goods as a biosimilar pricing is invariably lower than that for the originator product. Some of the key focus areas for CMC development such as high productivity & stable clone, robust process and a strong control strategy for glycans, charge variants and size variants, adequate analytical characterization, sufficient demonstration of clinical efficacy and safety are vital for approval of a biosimilar product. The entire journey of a molecule under development will be illustrated and discussed.
Speaker Bio:
Sanjay Tiwari graduated from the Indian Institute of Technology, Delhi with a 5 years integrated M.Tech in Biochemical Engineering and Biotechnology in the year 1996. He later obtained Ph.D. in Biotechnology from the Indian Institute of Technology Madras, Chennai. During his 26 years of industrial experience, he has worked in various capacities and on industry relevant, diverse subjects of biotechnology such as process and analytics development, scale Up, manufacturing and Manufacturing support, product portfolio enhancement, green field and brown field projects, health agency inspections and regulatory submissions for different types of products such as enzymes, proteins and peptides, small molecules, monoclonal antibodies. He has extensively worked on process control strategies for maintaining quality and yield of the products manufactured by fermentation processes or cell culture. His research areas include process and analytics for manufacturing and characterization of biologics and biosimilars. He has worked with several key Indian Biopharma companies such as Biocon and Lupin Limited. He is currently working as head & VP, R&D, Lupin Limited (Biotech Division), Pune.