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Updated: Feb 16, 2026

BioMEMS and Cellular Biology: Perspectives and Applications
Published on: October 1, 2007
A Regulatory Perspective on Testing of Biological Activity of Complex Biologics
Marianne Saldanha1, Prajakta Dandekar2, Ratnesh Jain1
1Department of Chemical Engineering, Institute of Chemical Technology, Nathalal Parekh Marg, Matunga, Mumbai 400019, India.
Abstract:
Antibody-drug conjugates (ADCs) and bispecific antibodies are becoming increasingly popular. However, their complex structures mandate stringent regulatory guidelines to ensure their safety and efficacy. We have briefly reviewed the existing regulatory guidelines and presented our perspectives on refining them to hasten the transition of these drugs from laboratories to market.
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