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CDMO activities

The CDMO activity is conducted on a customized basis, either for clinical trials or for commercial manufacturing.

The core of CELLforCURE CDMO services includes:

  • Technical transfer from customer (Process; QC methods, etc.)
  • Optimization and Industrialization of processes
  • Manufacturing of GMP batches
  • Comparability studies
  • Process validation
  • Supplier qualification
  • Analytical methods validation
  • Release of GMP batches : certification of batches used in clinical trials and release of commercial batches
  • Logistics and commercial distribution
  • Claims and batch recall

CELLforCURE also offers the following support functions:

  • Analytical tests for selection and identification of critical raw materials
  • Stability studies
  • Transport stability test and validation
  • Other type of studies specifically requested

See also

Producing « therapeutic cells »