Whitepaper: Early product characterisation mitigates risks in biologics development
Product characterisation facilitates easier process design to ensure the biological drug attains critical product safety, purity, and potency.
Product characterisation is the essential foundation for successful biological drug development. In-depth knowledge of a product’s chemistry, structure, and biological activities facilitates easier process design to ensure the drug attains critical product safety, purity, and potency. Key is understanding the relationship between the basic physicochemical profile and biological activity and how this relationship affects clinical performance thus enabling a developer to make informed decisions that accelerate development and reduce risk throughout the product’s life cycle.
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Biologics, Biopharmaceuticals, Bioprocessing, Biosimilars, Chromatography, Endotoxin, Gene therapy, Good Manufacturing Practice (GMP), Ingredients, Manufacturing, Mass Spectrometry, Outsourcing, QA/QC, Regulation & Legislation, Research & Development (R&D), Vaccines