Biopharmaceuticals and Biosimilars

Biopharmaceuticals and biosimilars have revolutionized the treatment landscape by offering highly targeted, effective, and personalized therapies for a wide range of diseases, including cancer, autoimmune disorders, and rare genetic conditions. This session provides an in-depth overview of the chemical, analytical, and formulation challenges associated with biologics such as monoclonal antibodies, therapeutic proteins, peptides, vaccines, and recombinant DNA products. It covers upstream cell-line development, downstream purification processes, formulation optimization, stability enhancement, and cold-chain considerations. The session also focuses on biosimilar development, including physicochemical and biological characterization, comparability exercises, immunogenicity assessment, and clinical equivalence studies. Regulatory pathways, global approval requirements, manufacturing scalability, cost-effectiveness, and market access strategies are discussed to provide a comprehensive understanding of biopharmaceutical development and commercialization.

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