Description
Summary:
Describes a method of determining the heavy and light chain immunoglobulin isotypes present in murine monoclonal antibody preparations. Suitable for testing materials used in the production of antibody from murine hybridoma cells in culture, and can also be used for in process testing of hybridoma secreted products. This procedure is for Research and Development use only and is not to be used for product release.
Included Sections:
Purpose, Scope, Responsibility, References and Applicable Documents, Materials and Equipment, Health and Safety Considerations, Documentation Requirements, and Procedures
Included Attachments/Appendices:
None
About This Document:
This is not a generic template, it's a 6-page procedure that was actually created and used in the Laboratory R&D 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:
- Process Development Personnel
- Method Development Personnel
- Quality Control Personnel
Product Details
- Edition:
- 1.0
- Published:
- 08/01/2007
- Number of Pages:
- 6
- File Size:
- 1 file , 370 KB
