Establising Structural Comparability with Effective Preclinical Characterization Methods

Establising Structural Comparability with Effective Preclinical Characterization Methods
Danny K. Chou, PharmaD, PhD President, Compassion BioSolution, LLC, presents on key issues in biosimilar drug product development, general strategy for developing biosimilars that are comparable with or superior to innovator drugs, how to improve market competitiveness by incorporating a high concentration formulation into pre-filled syringe or alternative delivery systems, the role of protein aggregate and subvisible particulate analysis in product stability monitoring and PFS development.

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