CRED Getting the CMC Dossier Right 2024

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Biologicals - Quality Attributes

Other tests

● pH

● Osmolality

● Microbial limits

● Endotoxins

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Biologicals – Quality Attributes

● Specifications are linked to a manufacturing process.

● Specifications should account for the stability drug substance (and drug product).

● Specifications are linked to preclinical and clinical studies.

● Specifications are linked to analytical

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