Packing material life verification of Prep Chromatography

Chromatography?packing material s are generally used in the production of biological drugs and are the key raw materials for the final refining of bulk drugs.According to the third Quality Control?Procedures?for?Raw?Materials?and?Excipients?Used?in?the?Production?of?Biological Products in Chinese Pharmacopoeia (2015 edition), chromatography packing material ?are classified as level 3 raw materials with moderate risk, and corresponding quality control is required.In recent years, the management and validation of chromatography packing material s for purified antibodies and proteins has become one of the key regulatory and field verification?projects.?In?addition,?for?insulin?and?GLP-1?and?analogues,?CDE?is?increasingly requiring manufacturers to provide packing life data.

The repeated use of chromatography?packing material s can greatly reduce the production process cost, but the performance of the packing material s will also decrease with the increase of repeated use.The properties of chromatography?packing include sample loading, purity, recovery and removal rate of process-related impurities, as well as the properties of chromatography?packing such as bonding phase density, particle size distribution, pressure, etc. The decrease of chromatography?packing performance directly affects the safety and effectiveness of the final product drug.Therefore, from the perspective of process cost and process performance, it is necessary to strictly and scientifically define the service life of the chromatography packing material . The aim of this article is to verify the theory and method of chromatography?packing life, we can infer from the trend, before is being strict?with antibodies and?protein drugs, now?fermentation drugs such?as insulin and glp-1 analogue drugs used for Low pressure chromatography and high pressure chromatography, high pressure chromatography are required to do life test, the synthetic peptides, lalu peptide, Somarlutide will also be asked for gradually.

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