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CELLULAR THERAPEUTICS

Contract GMP/GTP Manufacturing and Testing Services  

AppTec, a GMP/GTP/GLP contract manufacturing and testing company, 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. 

Manufacturing / Processing Capabilities

    •  Autologous / stem cell processing

    •  GMP cell bank production

    •  Cell expansion for allogeneic cell therapies and vaccines

    •  Cryogenic storage

    •  Commercial-scale production

    •  GMP monoclonal antibodies for cell selection 

Cell Culture Production Options

Flasks (all types)

Wave Bag

Roller Bottles

Cell Factories

Spinner/Shake Flasks

Bioreactors 

Testing Services

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

   •  cell line characterization

   •  mycoplasma, sterility & 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  

The 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. 

Customized ProgramsAppTec's scientists are experts in developing customized manufacturing programs, as well as providing customized testing to meet a client's particular needs. 

Additional Services – Cell Alliance

AppTec is a founding member of Cell Alliance, a global partnership of biotech service providers formed to support cellular therapeutics companies.  For more information, contact an AppTec Account Manager.