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Cell Culture & Purification Suites Commissioning, Qualification and Validation

Duration- 12 months


Develop and perform Commissioning, Qualification, and Validation (CQ&V) of new Cell Culture and Purification manufacturing suites within an existing biopharmaceutical commercial/clinical manufacturing facility.  Each manufacturing suite is approximately 1000 SF.

 Scope of Work:

The Cell Culture and Purification manufacturing suites CQ&V included Design Qualification, FAT, IQ, and OQ for the following equipment utilities systems:

  • Biosafety Cabinet
  • Incubator Shaker
  • 300L Fermentor
  • Centrifuge
  • Homogenizer
  • Hollow Fiber TFF
  • Several Portable Temperature Control Skids
  • Several Single Use Bag/Mixer Skids
  • Portable CIP Skid
  • Laminar Flow Hood and Fume Hood
  • UF/DF Skid
  • Chromatography Skid and Columns
  • Disposable Heat Exchanger
  • WFI point-of-use Cooler
  • -70°C Product Freezer
  • Water for Injection
  • Purified Water
  • Process Air
  • Clean Steam
  • Oxygen
  • Nitrogen
  • HVAC / BAS

The project concluded with Cleaning Validation, SIP Cycle Development and Validation, Temperature Mapping, and Performance Qualification activities.