Testing and Inspection Technology Platform

Whether for prokaryotic or eukaryotic system expression and biological product production, there is always a certain degree of residue in the product. Therefore, residue testing is necessary, as it directly affects product quality.

Whether for prokaryotic or eukaryotic system expression and biological product production, there is always a certain degree of residue in the product. Therefore, residue testing is necessary, as it directly affects product quality.For example, Bovine Serum Albumin (BSA), a major component of fetal bovine serum, is widely used in the production of biological products such as antibody drugs, vaccine products, and cell and gene therapy (CGT) drugs. For vaccine products, many viral vaccines (such as those for rabies, measles, mumps, rubella, and chickenpox) are produced using cell culture methods. Therefore, testing for BSA residues is an important quality control indicator for vaccine products, as it directly impacts the safety of the vaccine.

Additionally, antibiotic residues pose serious health risks to humans, including "three hazards" (carcinogenic, teratogenic, and mutagenic effects). Long-term exposure to such drugs typically does not cause acute poisoning but may lead to chronic poisoning.

Although antibiotics are not essential components in vaccines, some antibiotics are added during vaccine preparation to prevent bacterial contamination. These antibiotics must be removed as much as possible before the final product is released.

The 2020 edition of the Chinese Pharmacopoeia, Volume 3, specifies the maximum allowable BSA residue levels for various vaccine drugs: not exceeding 50 ng/ml (except for hepatitis A inactivated vaccine) for stock solution, and not exceeding 50 ng/dose in final product.

Our company has established a corresponding residue testing technical system in accordance with the above regulatory requirements. The specific items are listed in the following table: