Bioassay and Immunogenicity: A Perspective

Duration: 1 hour 33 minutes

Bioassay development is a complex process where analysts have to understand biological effect/mode of action of the drug in question and evaluate its immunogenicity. The method selected should be reliable, sensitive, and reproducible and should minimize errors due to biological variation and methodology. Join this session as Dr Dadke shares his expertise on bioassay development and describe the several potential candidates to evaluate immunogenicity of pharmaceutical drugs.

Learning Objectives:

Introductory perspective on bioassay and explore different types of Bioassays
Understand the bioassay from the regulatory view and know the requirements of an ideal bioassay
Case study on testing for presence of Innate Immune Response Modulating Impurities (IIRMI) in Peptide Drugs

In Collaboration with:

Speakers

Shrikrishna Dadke
Vice President, Analytical (Small and Large Molecules)
Vimta Labs Ltd, Hyderabad

Dr. Shrikrishna Dadke is currently working as Vice President, Analytical division (small and large molecules) at Vimta Labs Ltd, Hyderabad. Dr. Dadke has an extensive experience of over 23 years, in both Academia and Industry. Upon completion of PhD from ACTREC, Mumbai, he has worked at organizations like Abbott Laboratories USA, Fox Chase Cancer Center USA, Lupin Limited, Dr Reddy’s Laboratories and Accutest Biologics. He holds numerous publications and his research in the field of Diabetes is also published and cited as a ‘hot article’ in a Nature Cell Biology publication. He has deep expertise in biosimilar characterization (cell based and analytical), small molecule mechanism of action studies etc.

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