Method Validation of Capillary Zone Electrophoresis Technique for Identity Testing of Biotherapeutic Products: Monoclonal Antibody
Keywords:
CZE, biotherapeutic products, monoclonal antibodyAbstract
Capillary zone electrophoresis (CZE) is one of the analytical techniques for identity testing of biotherapeutic products (BTP) produced by biotechnological techniques for example: monoclonal antibody, hormones and cytokines. Therefore, this study was aimed to validate CZE by using PA 800 plus capillary electrophoresis system (Beckman Coulter), neutral coated capillary and UV detector at 214 nm. The proposed CZE condition showed high specificity and percent relative standard deviation (%RSD) of precision of main peak was less than 0.2. Moreover, the method was robust as shown in results of 0.2 %RSD when tested by two different analysts and different lots of elution buffers or capillary tubes. The obtained data suggested that CZE is potential for using as one of analytical methods for identity testing of BTP for marketing authorization in Thailand.
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