Ravish Patel | Senior Manager
Sun Pharma

Ravish Patel, Senior Manager, Sun Pharma

Dr. Ravish Patel is currently a Senior Manager- I at Sun Pharmaceuticals Ltd. in the Pharmacology and Bioassay Group. Before joining Sun Pharmaceuticals in 2021, He served Wockhardt Biotech, Cipla, Cadial, and Intas Biotech in different capacities. Ravish has about 14 years of experience in the development of cell-based (functional) and Binding assays (ELISA assays) for Bio-therapeutics. In the department, Ravish has been supervising several interns as well as master students and is involved in both transfers of assays from Research to CMC and from CMC to QC labs prior to launch. He received his Ph.D. in biotechnology from Niram University and a Master’s degree in Microbiology from the University of Mysore.
Ravish has been actively involved in industry discussions focusing on functional characterization of Bio-therapeutics and Bio-similarity assessment to support various modalities, including mAbs, fusion Proteins, and Immune Checkpoint Inhibitors (ICIs). Furthermore, his background in biological assay development and validation helped to provide him to best lead a key team of scientists within the global discovery services group at Sun-Pharma.


Festival of Biologics Day 1 @ 11:30

Antibody Roundtables

Enhance therapeutic efficacy by modulating Fc function

Festival of Biologics Day 2 @ 17:20

Potency Assay for Novel Product type: Challenges and Considerations

A potency assay is the quantitative measure of biological activity, ideally, it measures the ability of the product to elicit a specific response in a disease-relevant system. One of the major challenges in developing assays for the novel product is the mechanism of action of a product which could be very complex and it may be difficult to establish a direct correlation with the clinical indication. For instance, novel product such as bispecific antibodies, Cell, gene therapy products, and antibody-drug conjugates is still in a nascent stage, and regulatory and quality requirements are still evolving. Moreover, there is a need to harmonize the regulatory guidance to apply the best assay development practices.

We discuss different approaches, in particular, the limitations and future directions. In addition, we note the need for an internationally harmonized procedure for bioassay throughout the drug development and the product lifecycle with a better understanding from both regulatory and technological perspectives.

last published: 31/Jan/23 09:55 GMT
last published: 31/Jan/23 09:55 GMT

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