Description
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
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 6
- File Size:
- 1 file , 380 KB
