DOXPUB 02-0041-SOP
standard published 08/01/2007 by Doxpub, Inc.
standard published 08/01/2007 by Doxpub, Inc.
Summary:
Describes a method for determining the heavy and light chain isotype present in murine monoclonal antibody preparations. Suitable for testing materials used in the production of antibody from murine hybridoma cells in culture.
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 4-page procedure that was actually created and used in the Bioprocessing 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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