DOXPUB 15-0005-SOP PDF

Summary:

Describes a procedure for the production of a master cell bank from a hybridoma cell line. Applies to the development of clinical grade hybridoma cell banks during product evaluation phase.

Included Sections:

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

Included Attachments/Appendices:

Batch Record for Production of Master Cell Bank from Hybridoma Cell Line, Cell Bank Repository Log, Test Results Worksheet, Reference Flow Chart

About This Document:

This is not a generic template, it's a 14-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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Who Will Benefit:

• Process Development Personnel
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