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Samir Lakhashe, Ph.D.

Samir has over 20 years of experience in biologics, focusing on the development of various analytical methods. His experience includes defining analytical target profiles, identifying critical quality attributes, and management of analytical process life cycle. He has expertise with viral vaccines, monoclonal antibodies, mesenchymal stromal cells, engineered tumor-infiltrating lymphocytes, CAR-T cells, and has worked across the disciplines of immunology, cell biology, virology, molecular virology, and protein chemistry-based analysis. His specialty is analytical method development, phase-appropriate qualification or validation, QC transfer, and method implementation in the GXP environment.

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