DOXPUB 15-0013-SOP PDF

Summary:

Describes a method of determining the heavy and light chain immunoglobulin isotypes present in murine monoclonal antibody preparations. Suitable for testing materials used in the production of antibody from murine hybridoma cells in culture, and can also be used for in process testing of hybridoma secreted products. This procedure is for Research and Development use only and is not to be used for product release.

Included Sections:

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

Included Attachments/Appendices:

None

About This Document:

This is not a generic template, it's a 6-page procedure that was actually created and used in the Laboratory R&D 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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