Whitepapers/App Notes/Posters

Whitepaper: Early product characterisation mitigates risks in biologics development

Posted: 4 March 2021 | | No comments yet

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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