概述:描述用于不同抗体纯化或修饰的设备、用品和环境的转换程序。适用于在生产设施中纯化/生物素化抗体。包括的章节:目的、范围、责任、参考和适用文件、材料和设备、健康和安全注意事项、文件要求和程序包括的附件/附录:抗体转换程序工作表本文件:这不是通用模板，这是一个长达3页的程序，实际上是在一家FDA监管机构的生物加工操作中创建和使用的。公司特定信息（名称、地址、一些图片、专有产品信息等）。 )已被修订，但内容和格式基本保留。购买理由:将其作为你自己文档项目的起点，将你文档的质量与你所在行业的同行进行比较，了解你所在行业的其他公司在做什么，哪些公司会从中受益:生物制造人员流程开发人员方法开发人员

Summary:Describes the procedures for changeover of equipment, supplies and environment used for different antibody purifications or modifications. Applies to purifying/biotinylating antibodies in the manufacturing facility.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Antibody Changeover Procedure WorksheetAbout This Document:This is not a generic template, it's a 3-page procedure that was actually created and used in the Bioprocessing operations of a FDA-regulated establishment. The company-specific information (names, addresses, some images, proprietary product information, etc.) has been redacted but the content and format have been largely preserved.Reasons to Buy:Use it as a starting point for your own documentation projectCompare the quality of your documents against your industry peersLearn what other companies in your industry are actually doingWho Will Benefit:Biologic Manufacturing PersonnelProcess Development PersonnelMethod Development Personnel