DOXPUB 09-0101-SOP

Summary:

Describes a procedure to quantitate the concentration of total IgM protein (both immunoreactive and inactive) present in tissue culture supernatant and ascites fluid by size exclusion HPLC. References Beckman HPLC and Gold Nouveau Software v1.0 or equivalent. Applies to the quantitation of monoclonal IgM from tissue culture supernatant, ascites fluid, purified bulk, and vialed preparations of IgM. Covers data reporting, system suitability testing, procedures and documentation requirements.

Included Sections:

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

Included Attachments/Appendices:

IgM Quantitation Report FormTest

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.

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