BSA Detection Kit (Enzyme-Linked Immunosorbent Assay)

Cell culture methods are widely adopted in the production processes of fields such as vaccines, cell and gene therapy (CGT). Cell culture media usually contain fetal bovine serum, and bovine serum albumin (BSA) is one of its main components, providing the key nutrients required for cell growth. BSA is an exogenous protein. Once it enters the human body, it may trigger immune responses and allergic reactions. Therefore, in the production process and release testing of biological products, the pharmacopoeias and ICH of various countries strictly control the BSA residues in vaccines and other biological products.
The 2025 edition of the Chinese Pharmacopoeia (Part III) clearly stipulates that in all vaccine products, the residue of BSA shall not exceed 50 ng/mL or 50 ng per dose (except for inactivated hepatitis A vaccines). The United States Pharmacopeia stipulates that the residue limit of BSA in biological products is 50 ng per dose or 500 ppm. The European Pharmacopoeia requires that the residue of BSA be controlled between 0.1 and 1.0μg per dose.
This product uses the ELISA double antibody sandwich method to determine the BSA content in the sample. Anti-bsa antibody is coated on the solid-phase carrier microplate, and the standard or sample to be tested is added. The BSA detection antibody is formed to create an antibody-antigen-detection antibody complex. The content of BSA in the sample to be tested is quantitatively detected by color development. This series of reagent kits has undergone comprehensive methodological validation in accordance with relevant regulations, guidelines and other document requirements, and can provide performance validation reports.

ForQuantitative detection of variousrawThe content of BSA in intermediate products, semi-finished products and finished products of physical preparations (such as vaccine drugs, cell therapy, stem cells and tissue engineering products, etc.) can be used for monitoringrawResidual BSA during the production process and product release.