PDA TR14_柱层分离工艺_Column Separation Process_1992.pdf

Industry Perspective ontheValidationof Column-Based Separation Processes forthe Purificationof Proteins 蛋白质净化柱层分离工艺验证的工业观点 I. Foreword 前言 The purpose of this document is to outline some of the significant issues related to the validation of column-based separation processes used in the purification of proteins produced by recombinant DNA (rDNA), hybri-doma technology, or peptide synthesis.While validation of these processes has been identified as a first priority by the PDA Biotechnology Task Force, the issues raised in certain sections of this document may have broader applications, including processes for non-protein pharmaceutical products purified by HPLC, as well as protein pharmaceuticals which are not produced by rDNA, hybridoma, or peptide synthesis technologies. 此文件目的是列出与DNA重组 (rDNA)，杂交瘤技术或肽合成产生的蛋白质净化所使用 的柱层分离工艺验证相关的一些重要问题。这些工艺的验证是PDA生物技 术特别小组最重要的任务，此文件某些章节提到的问题可能有更广泛的应用，包括由 HPLC净化的非蛋白质药品工艺，非DNA重组 (rDNA)，杂交瘤技术或肽合成技术产生的 蛋白质产品。 While column-based separations are key purification techniques in the production of recombinant proteins and monoclonal antibodies, little has been written regarding the validation of these processes. In general, process validation is the assurance that product quality is derived from careful attention to a number of factors, including process design, selection and use of quality parts and materials, and control of the process through appropriate in-process and end-product testing. In May 1987, the Center for Drugs and Biologies and the Center for Devices and Radiological Health of the Food and Drug Administration published the Guideline on General Principles of Process Validation. While this guideline is useful, it does not include all of the specific elements required in the validation of a manufacturing process. Therefore, the PDA established the Biotechnology Task Force on Purification and Scale-up to develop a practical guide forthe validation of column-based separat