Accelerate biotechnology

Stability Studies

Batavia Biosciences identifies and develops the stability determining assays for the final product and all intermediate formulations in the production process.

Stability determining assays are developed and utilized in drug substance and drug product stability studies as well as to support the development of the final drug substance and drug product formulations. Once identified in pilot stability studies, assays are fully developed and qualified according to GMP requirements.

Drug substance and drug product stability studies can be performed in-house or protocols can be transferred to the client’s commercial manufacturing setting to allow commercial batch release.

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Product Characterization

Product Release

Clinical Manufacturing