Batavia Biosciences develops all required product specific assays to ensure proper release of your biopharmaceutical product.
As a service we can perform these assays through our QC department and release the GMP drug product through our in-house Qualified Person (QP).
Upon request, assay protocols can be transferred to the client’s commercial manufacturing setting to allow client commercial batch release. We frequently develop and validate assays as products move through the preclinical and clinical phases on to the market.
Batavia Biosciences’ assay portfolio includes assays for Identity and Integrity, Concentration, Purity, Potency, Stability and Residuals.