The 2020 edition of the Chinese Pharmacopoeia (Part III) has clearly stipulated the residue levels of BS A in various vaccine drugs, and most of them should not exceed 50ng/mL. The residual amount of BSA is also subject to detection requirements in CGT. The most common method is to detect and control the content of BSA using ELISA. Among them, the sandwich ELISA is the first choice due to its strong specificity, high sensitivity, wide linear range and good result repeatability. Through independent research and development and production, Baorui Biotechnology has specially launched the BSA detection kit (Enzyme-linked immunosorbent Assay - one-step method). The standard substances in this kit have been traced back to the national standard substances (140619-202432), and are developed and produced in accordance with the ISO9001 and ISO13485 quality management systems.




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.
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