Paragon offers working and master cell banking services whether as part of a larger GMP production run or contracted as an individual project. Segregated cell banking suites are maintained for either microbial and mammalian production.
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Facilities
Paragon maintains a dedicated suite for establishing cGMP cell banks. The suite is segregated, so that Paragon can serve customers requiring either mammalian or microbial cell banks. The microbial and mammalian suites are classified as ISO 7 with single pass, positive pressure HEPA filtered air. The personnel and materials flow is unidirectional within the facility with entry and exit airlocks. Cell banking work is performed within certified Class II (Type A, B1, B2, B3) laminar flow biosafety cabinets. Cells are grown, maintained and stored within validated incubators and freezers (liquid nitrogen). The suites are monitored by a 24-hour security system and HVAC monitoring system. There is also an environmental monitoring program which ensures the suites are cleaned and maintained to specifications.
Documentation and Quality Oversight
Paragon will establish a batch record specific to meet the requirements of each client. The batch record can either be a standard format established by Paragon or customized to meet the client’s needs. The batch record will capture all raw materials and procedures required to establish the cell bank. The document is 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 (SOPs, batch records, validation reports, etc.), and 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.
As part of our Quality Assurance procedures, all cell banks are segregated and produced on a campaign basis. Between call banking projects, Paragon deploys validated cleaning and change over procedures in all the suites, to significantly reduce the risk of contamination. In addition, all raw materials used in cell bank production are sourced from QA-approved vendors and released for use following Paragon’s raw materials release procedures. Prior to initiating any cell banking project, the seed stock must be certified as free of Mycoplasma or Bacteriophage and tested for sterility.
Cell Expansion, Harvest, and Cryopreservation
Paragon is 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. The bank can be prepared to the client’s specifications with regard to cell concentration and number of vials.
The vials are stored at Paragon in a validated, vapor phase liquid nitrogen freezer until release to the client. Liquid nitrogen freezers are monitored electronically 24/7 on an automated notification system in case of an alarm condition. Paragon can ship the cell bank directly to the client or to a specified secondary storage site.
Reporting
Paragon issues a QA-approved Certificate of Analysis (CoA) upon completion of every cell banking project. The CoA includes all relevant manufacturing and freezing documentation. In addition, Paragon will report all test results included in the release of the cell bank as specified by the client.