DOXPUB 09-0143-SOP PDF

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
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Who Will Benefit:

• Quality Assurance Managers
• Manufacturing Managers
• Quality Control Personnel