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Vijay Jethwa, Ph.D., is a senior consultant at Biologics Consulting. He has over 25 years of industry experience in the development, validation and routine performance of potency assays, cell-based bioassays and immunoassays for diagnostics, PK/PD studies, drug substance and drug product characterization, lot release and stability, as well as immunogenicity assessments.  

 

Jethwa started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, NC. His group developed and transferred analytical methods for the characterization and release of live virus vaccines. Prior to joining Merck, he was at Biogen Idec for over 12 years in various capacities, including leading all CMC activities related to biosimilar development and serving as the site head of the cGMP Bioassay, Microbiology and Virology QC Laboratories. He established GLP testing laboratories at Biogen, including laboratory design, equipment sourcing and validation, supporting antibody and PK/PD testing for various GLP/GCP studies.  

 

Jethwa prepared and presented Quality sections for Regulatory advice meetings and has authored, reviewed and approved sections of several regulatory submissions (IND, IMPD, BLA, etc.).