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DOXPUB 02-0060-SOP

$14.50

Adjusting Antibody Solution Concentration by Dilution
standard by Doxpub, Inc., 08/01/2007

Category:

Description

Summary:

Describes the procedures used to dilute antibody solutions to a required concentration. Applies to products that are manufactured for clinical or commercial distribution where the instructions for dilution are not contained in a Manufacturing Batch Record (MBR). Covers measuing, calculating, diluting, final volumes, labeling and completing documentation.

Included Sections:

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

Included Attachments/Appendices:

Antibody Dilution Worksheet

About This Document:

This is not a generic template, it's a 6-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

Product Details

Edition:
1.0
Published:
08/01/2007
Number of Pages:
6
File Size:
1 file , 380 KB