Clinical Research Management




Biologic Manufacturing Solutions

 

Biological ManufacturingCRM provides personnel to support and manage the U.S. Army's Pilot Bio-Production Facility. We provide specialized cGMP technical personnel to the WRAIR Pilot Bio-Production Facility, for the research, development, production and testing of vaccines and other biological products. These pilot-scale (1,000-10,000 doses of finished lot) vaccines are produced under current cGMP conditions and all products are tested in compliance with GLP.

We provide the following GMP services:

  • Quality Assurance
  • Quality Control
  • Seed Preparation and Fermentation
  • Documentation and Corrective Action
  • Failure Investigations
  • Change Control
     



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