Description
Summary:
Provides a procedure for determining the purity and aggregate content of native and biotinylated monoclonal IgM preparations by size exclusion high performance liquid chromatography (SE-HPLC). Applicable to the analysis of native and biotinylated IgM derived from ascites or tissue culture. Covers sample preparation, system suitability test, and calculations.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
HPLC-IgM Purity Assay Report Form, HPLC Analysis Sheet
About This Document:
This is not a generic template, it's a 7-page procedure that was actually created and used in the Quality Control 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:
- Quality Assurance Managers
- Manufacturing Managers
- Quality Control Personnel
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 7
- File Size:
- 1 file , 380 KB
