DOXPUB 02-0009-SOP

Summary:

Describes the requirements for packing, cleaning, equilibrating, and storing an Sephacryl HR column in an XK series column for chromatography. Applies to GMP purifications of antibody. Covers calculating size and height of column, cleaning rinsing, assembly, pouring, packing, leak and headspace checks, washing, equilibration, and storage.

Included Sections:

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

Included Attachments/Appendices:

Form: Sephacryl HR in an XK series Column

About This Document:

This is not a generic template, it's a 5-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
• Process Development Personnel
• Method Development Personnel