DOXPUB 02-0062-SOP

Summary:

Provides the methods used for general cell culture expansion and maintenance. Specific protocols may be prepared as needed for particular cell lines. Covers cell coutning using a hemacytometer, inoculating (seeding) and scale-up (splitting) of cell cultures, harvest of adherent (attachment dependent) cell lines, remove of cells by Trypsin or Trypsin-EDTA, removal by EDTA, removal by scraping, maintenance of attachment-dependent cell lines, maintenance of non-attachment-dependent cell lines, and cleanup. Also includes description of indications of instability or deterrioration of cell cultures.

Included Sections:

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

Included Attachments/Appendices:

Generic Cell Line Scale Up and Maintenance Form

About This Document:

This is not a generic template, it's a 9-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