Establishment and application of the quality control technology system for recombinant drugs in China: A review / 中国药学杂志

ABSTRACT

In order to ensure the safety and effectiveness of biotech drugs, the CFDA has released a series of regulations and guidelines, and the NIFDC established an effective quality control technology system for recombinant drugs. This paper briefly reviews the important development stage of pharmaceutical biotechnology and the research and development situation of recombinant drugs in China, introduces in detail the establishment and application situation of the quality control technology system for recombinant drugs in the last 30 years in China, including the research basis and regulatory requirements for the quality standard, the quality standards of recombinant drugs in Chinese Pharmacopoeia Part III and the quality control requirements for recombinant drugs in the current Pharmacopoeia, the support of national science and technology projects for establishing quality control system of biotechnology drugs by NIFDC and the establishment and application of the recombinant drug quality standards and all kinds of test methods such as the determination of biological activity and protein content, physical and chemical analysis and protein structural identification, determination of purity and impurity since 1986; development of national standards for biological activity and content determination, establishment and validation of the quality standards of the physical and chemical reference substances used for peptide mapping analysis and isoelectric point determination of recombinant drugs; analysis of inspection reports of a total of 5 920 batches of biotech drugs for all kinds of tests including registration inspection, import inspection, sample inspection, commission, and contracts tests completed by Division of Recombinant Biological Products, IBPC, and NIFDC since 2001.