- 1、本文档共23页,可阅读全部内容。
- 2、有哪些信誉好的足球投注网站(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
查看更多
Industry Perspective on the Validation of Column-Based Separation Processes for the Purification of Proteins蛋白质柱层析分离纯化验证现状Foreword前言The purpose of this document is to outline some of the significant issues related to the validation of columnbased separation processes used in the purification of proteins produced by recombinant DNA (rDNA), hybridoma 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. 这个文件的目的是概述一些关于重组DNA(rDNA),杂交瘤技术,或多肽合成过程中有重大意义的柱分离纯化验证。当这些过程的验证已作为PDA生物技术工作团队的首要任务时,本文件中所提及的问题可能有更广泛的应用,包括利用高效液相色谱技术纯化非蛋白医药产品,又包括不通过rDNA,杂交瘤,或肽合成技术生产的蛋白质药品。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 Biologics 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 for the validation of column-based separations used in the manufacture of proteins intended for use as therapeutic or diagnos
您可能关注的文档
- 董事会及经营团队的各自职责.doc
- 董事会在公司治理.doc
- 董事长助理转正申请0.doc
- 董事长在农商行2017年度工作会议上的讲话.doc
- 董晓波实用文体中英文翻译教程英汉双向9787566303646第八章商务文本的中英文翻译.ppt
- 蒙古包介绍16.ppt
- 蒙古族舞蹈风格特征.doc
- 蒙牛公司的战略管理分析.doc
- 蒙牛外部环境、内部环境分析.doc
- 蒙牛的外部环境分析.doc
- 【课件】Unit+4+Section+A++Grammar+Focus++课件人教版七年级上册.pptx
- 【课件】有理数的减法+课件+人教版七年级数学上册.pptx
- 【课件】有理数的大小比较+课件人教版(2024)数学七年级上册.pptx
- 【课件】有理数的乘法课件人教版数学七年级上册.pptx
- 高考30天冲刺主题班会市公开课获奖课件省名师示范课获奖课件.pptx
- Unit-6I-like-music-that-I-can-dance-toPeriod-1人教新目完整版.pptx
- 坚持唯物辨证法-反对形而上学.pptx
- 7-怎么都快乐市公开课一等奖课件名师大赛获奖课件.pptx
- 背部专业知识.ppt
- 高考生物一轮复习课件专题七-遗传的分子基础必修2市公开课获奖课件省名师示范课获奖课件.pptx
最近下载
- 超星网课尔雅《服装流行分析与预测》尔雅答案2022章节测试答案.docx
- ZG-108阻垢剂安全技术说明书.doc VIP
- 人教版2024-2025学年七年级数学上册综合与实践 进位制的认识与探究(习题课件).pptx VIP
- 事业单位工勤技能岗位驾驶员职业技能考试真题汇总.pdf
- 蓝色橙色扬帆起航携手并进简约商务工作述职报告.pptx
- 2024年RDPAC认证考试必备题库-上(单选题部分).docx
- 英文阅读-I Wonder.pdf
- 美国ITT赛莱默飞力FLYGT潜水污水泵N系列选型样本手册.pdf
- 通用版2023《铸牢中华民族共同体意识》专题精品课件.ppt VIP
- 借名买车协议书范本.docx
文档评论(0)