DOXPUB 09-0111-SOP

Summary:

Describes a procedure for determining the purity and/or apparent molecular weight (MW) of a protein preparation ( IgM, biotin, etc.), immunoconjugates and fragments. Applies to testing raw materials, in-process samples, bulk materials and finished components. Also applicable to determining the purity and apparent molecular weight of any protein preparation (monoclonal antibody, albumins, avidin, growth factors etc.), and for monitoring protein fragmentation reactions, digestion, breakdown of antibody, etc.

Included Sections:

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

Included Attachments/Appendices:

SDS-PAGE Assay Report Form, SDS-PAGE Analysis Logsheet

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