DOXPUB 02-0020-SOP

Summary:

Describes the requirements for packing, cleaning, equilibrating, and storing an Sephacryl HR Column in a pH armacia, BPG series column for chromatography. Applies to purifications of antibody, where a BPG column is utilized for packaging Sephacryl HR media. Also applies to personnel involved in any manufacturing for purification of antibody using Sephacryl HR chromatography.

Included Sections:

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

Included Attachments/Appendices:

Sephacryl HR Gel in an BPG series Column Packing and Initial Use Logsheet, Sephacryl HR Gel in an BPG series Column Reuse/Retest Logsheet

About This Document:

This is not a generic template, it's a 7-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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Who Will Benefit:

• Biologic Manufacturing Personnel
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• Method Development Personnel