概述:描述用于将抗体溶液稀释至所需浓度的程序。适用于为临床或商业分销而生产的产品，其中稀释说明未包含在生产批次记录（MBR）中。包括测量、计算、稀释、最终体积、标记和完成文件。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:抗体稀释工作表本文件:这不是通用模板，这是一个长达6页的程序，实际上是在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）已被编辑，但内容和格式已基本保留。 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 used to dilute antibody solutions to a required concentration. Applies to products that are manufactured for clinical or commercial distribution where the instructions for dilution are not contained in a Manufacturing Batch Record (MBR). Covers measuing, calculating, diluting, final volumes, labeling and completing documentation.Included Sections:Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and ProceduresIncluded Attachments/Appendices:Antibody Dilution WorksheetAbout This Document:This is not a generic template, it's a 6-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