DOXPUB 02-0003-SOP

Summary:

Describes a method of assembly, standardization and sterilization of the Cell pH arm Hollow Fiber Bioreactor for use in antibody manufacturing. Covers intra-capillary space (ICS) flowpath assembly, standardizing bioreactor, setting pH high and low limits, priming the bioreactor with WFP, standardizing the temperature probe, standardizing the feed rate, standardizing the recirculation rate, preparing accessory tubing, autoclaving the bioreactor, setting up the bioreactor, system startup and flush, pre-inoculation system check, system inoculation, cell inoculation, and shut down/tear down/regeneration.

Included Sections:

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

Included Attachments/Appendices:

Cell-Pharm Bioreactor Set-Up and Standardization Record

About This Document:

This is not a generic template, it's a 14-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
• Compare the quality of your documents against your industry peers
• Learn what other companies in your industry are actually doing

Who Will Benefit:

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