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Facilities
- two independent, dedicated suites for establishing cGMP cell
banks - segregated so Paragon can serve customers requiring either mammalian or microbial
cell banks
Documentation and Quality
Oversight
- batch records specific to meet the requirements of each
client are established
- records are approved and finalized under client supervision
- the Paragon Quality Assurance Group oversees the entire
process from the validation of the equipment, to the approval of the required documents,
to the release of the cell bank to the client
- the Quality Assurance Group interacts directly with the
client’s Quality Representative(s) to ensure the facility and procedures meet the
expectations of the client and the appropriate regulatory authority
- between call banking projects, Paragon deploys validated
cleaning and change over procedures in all the suites
Cell Expansion, Harvest,
and Cryopreservation
- capable of using multiple means for cell expansion to
manufacture a cell bank, such as T-flasks, cell factories, roller bottles, shake flasks
and spin flasks
- cells are cryopreserved in vials using a validated
controlled rate freezer
- cells are stored at Paragon in a validated, vapor phase
liquid nitrogen freezer until release to the client
Reporting
- Paragon issues a QA-approved Certificate of Analysis (CoA)
upon completion of every cell banking project
- Paragon will report all test results included in the release
of the cell bank as specified by the client
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