To ensure a safe and well controlled Biological Product, it is required that both activity and biochemical properties are well described. The API should be extensively characterized in terms of composition, the presence of heterogeneities, and higher order structure. To provide a safe biologic, one needs to demonstrate analysis of
Key attributes of a Biological Product are activity and potency, and therefore these parameters should be accurately monitored throughout production of the biological up to prolonged storage.
Eurofins BioPharma Product Testing Netherlands assists you in establishing, validation, or transfers of a broad range of methods and tests that can be used to demonstrate:
These tests can be employed for release, lot-to-lot comparisons, or to demonstrate bio-similarity.
A dedicated team of experts equipped with state of the art instrumentation helps you to safeguard consistent quality throughout the product lifecycle. Validated cGMP ensures fulfillment of regulatory requirements, enabling you to advance development.
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