Product/Service

Cell Therapy Services: Process Development And cGMP Manufacturing

Source: Excellos
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Now that you have the best donated cellular material, it is time to optimize your cell therapy process for cGMP manufacturing. We offer R&D services including process development and cGMP production for Phase I through Commercial manufacturing.

Custom Manufacturing to Your Specifications

  • Donor Management Services—We design the donor pool that matches your requirements.
  • cGMP Manufacturing facilities meet regulatory and safety requirements.
  • Manufacturing by Design (MBD) scales processes to increase efficiencies and lower costs.
  • Full QA oversight and documentation.

Features:

  • Customized assay and process development.
  • Technology transfer (hardware, know-how, QC, compliance).
  • Cell isolation, transduction and expansion.
  • Harvest, cryopreservation and storage.
  • Stability testing.
  • Full documentation.
  • ISO 7 cleanrooms.