DOXPUB 02-0031-SOP

Summary:

Describes procedures for preparing a proportional pool from retention samples of multiple ascites harvests. Applies to retention samples from lots destined for preparation of clinical quality antibody. Covers determining antibody concentration, calculating harvest targets, mixing the pooled ascites, aliquoting ascites in tubes, and storing aliquoted vials.

Included Sections:

Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures

Included Attachments/Appendices:

Ascites Proportional Pooling Worksheet

About 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 project
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

• Biologic Manufacturing Personnel
• Process Development Personnel
• Method Development Personnel