GMP Cell Banking

WuXi AppTec maintains seven individually monitored GMP cell banking suites. The cell bank facility at WuXi AppTec offers clients an opportunity to manufacture cell banks grown to client specifications, under exacting standards and QA oversight, in a highly monitored, secure and controlled environment. All work is performed in ultra-clean tissue culture suites by gowned, highly skilled personnel.

Many different species of mammalian or insect cell banks - ranging in size from 10 to 1200 vials - can be manufactured GMP using a variety of media types. Both adherent and suspension cells can be grown using cell culture methods that include T-flasks, cell factories, roller bottles and shaker and spinner flasks.

All cell banks are strictly segregated and produced on a campaign basis (i.e., one cell bank is produced within each suite at a time). Validated changeover and cleaning procedures, requiring Quality Assurance release of each suite prior to use, ensure cell line integrity and minimize adverse events and contamination.

cGMP Manufacture of Cellular Therapeutics

As a GMP/GTP/GLP contract manufacturing and testing company, WuXi AppTec offers a unique single-source, fully integrated approach for cellular therapeutics.  Our expertise in the area of cell-based products – combined with our advanced facility – ensures that we can provide the cutting-edge capabilities required by today's cell therapy companies.

The WuXi AppTec Facility

Manufacturing is conducted in facilities operating under strict GMP and GTP compliance, and comprising individually equipped, positive-pressure suites with ISO Class 5 (Class 100) laminar flow hoods.  The suites are HEPA filtered and continuously monitored and alarmed.  Validated systems and procedures ensure the highest quality in aseptic processing.  Comprehensive environmental monitoring programs have been established for both open and closed manufacturing operations.

Manufacturing / Processing Capabilities

  • Technology transfer
  • Process development
  • Transition from open to closed manufacturing systems
  • Shipping validations
  • Bar code system for sample tracking
  • Autologous / stem cell processing
  • GMP cell bank production
  • Cell expansion for allogeneic cell therapies and vaccines
  • GMP monoclonal antibodies for cell selection
  • Cryogenic storage
  • Commercial-scale production

Cell Culture Production Options

  • Flasks (all types)
  • Wave bag
  • Roller bottles
  • Cell factories
  • Spinner / Shake flasks
  • Bioreactors

Related Testing Services

With over 20 years of experience in testing biotherapeutics, WuXi AppTec is able to offer clients a comprehensive testing program for their cell therapy projects.  Available testing services include:

  • Cell line characterization
  • Mycoplasma, sterility and endotoxin assays
    (with fast turnaround times for autologous cell therapies)
  • Flow cytometry
  • Microbiological and adventitious viral agent testing
  • Molecular biology assays
  • Biodistribution and expression analysis
  • Potency / quantity (strength) testing
  • Raw material testing
  • Viral/bacterial inactivation, clearance and cleaning studies

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