DOXPUB 02-0006-SOP

Summary:

Describes a procedure for the concentration of antibody containing, conditioned, bioreactor supernatants. Intended to be used for the concentration of antibody containing conditioned media from bioreactors or static cultures of mammalian cells. May be applied to other purposes as they are identified. Covers concentration with hollow fiber cartridges and concentration with Millipore Minitan System.

Included Sections:

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

Included Attachments/Appendices:

Concentration Using Hollow Fiber Concentrator Accountability Control Form, Concentration Using Millipore, Minitan System Accountability Control Form, Concentrated Antibody Frozen Stock Log Form.

About This Document:

This is not a generic template, it's a 10-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.

Reasons to Buy:

• Use it as a starting point for your own documentation project
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Who Will Benefit:

• Biologic Manufacturing Personnel
• Process Development Personnel
• Method Development Personnel