Introduction of the related content of biotech drugs quality control in the Chinese Pharmacopoeia 2015 / 中国药学杂志

ABSTRACT

The Chinese pharmacopoeia 2015 has been issued. To better understand and implement the new pharmacopoeia, this article first briefly reviews the situation of biotech drugs quality control after the execution of the 2010 edition pharmacopoeia, lists related issues, and illustrates the necessity to study and understand the new pharmacopoeia and related documents in time. Then according to the relevant regulations and the Chinese pharmacopoeia 2015 Volume III, the contents of the draft of biotech drugs quality control are introduced, including research basis and regulations of quality standards, the general notice and related provisions of standard materials such as standard, reference, reference substance in the article 26 in the notice, general requirements and six requirements related to the production and quality control of biotech drugs, general monograph of human recombinant DNA technology products and general monograph of human recombinant monoclonal antibody products, the monograph and the China's 2013 annual valuation to sample vial recombinant human interferon alpha 2a as an example analysis for verification regulation related content, and appendices and the second method (reporter gene method) for determination of interferon biological activity in the new appendix. The advantages and disadvantages of the requirements on products contained in this edition of pharmacopoeia were discussed, as well as the regulations and technical background when the quality standards were formulated. Focus was put on the importance of peptide mapping analysis in the structure analysis of recombinant protein product and the stability evaluation of production process, key technical requirements in new general monograph of human recombinant DNA technology products, and the application of new technologies, such as LC-MS in structure analysis of biotech drugs protein and identification of reference substance, etc.