DOXPUB 02-0060-SOP

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 Procedures

Included Attachments/Appendices:

Antibody Dilution Worksheet

About 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 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