New Paradigm of Building Quality during Manufacture – Challenges with Biological Products
Posted on January 12, 2026
Rajesh K. Gupta, Ph.D., President and Principal Consultant, Biologics Quality & Regulatory Consultants, LLC
Introduction Biological products, biologicals or biologics are important class of drugs used in diagnosis, prevention and treatment of disease. These products are made from natural biological sources, including humans, animals and microorganisms, often made in cells, tissues, microorganisms and whol...
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