CPrep – Cell Preparation
From cryopreserved cell/gene therapy product to filled syringe ready for administration:
- Thaws, washes to remove DMSO, concentrate, syringe fill
- R&D version for method optimisation
- GMP version with Batch Manufacturing Record
- Benchtop GMP ready Processor and separate R&D or GMP Consumable
- Current version accepts Aseptic Technology AT-Closed Via® 2ml vials and delivers into BD 3ml Luer-lok™ Tip syringes.
- The new EU Advanced Therapy Medicinal Product (ATMP) guidelines, Eudralex Vol 4, Part IV, Good Manufacturing Practice for Advanced Therapy Medicinal Products states: “reconstitution activities can be performed at the administration site outside a GMP environment” subject to a number of caveats.
- The Processor is GMP equipment and forms part of the Cell Therapy Manufacturers (CTM) licensed process
- The Disposable is a GMP consumable and is manufactured, assembled, wrapped, labelled and sterilised by a reputable single use supplier.
- At the Point of Care (PoC), allowing expensive, short shelf life cell therapies to be transported and stored frozen and then thawed when everything is ready for administration. This also reduces the risks and costs of current manual methods
- Initiation of cell culture from a cell bank in a GMP facility with a standard repeatable process
- Thawing of cell samples for QC with a standard repeatable process.