Master & Working Cell and Virus Banks
Paragon offers working and master cell banking services either as part of a larger GMP production run or contracted as an individual project. Segregated cell banking suites are maintained for microbial and mammalian production.
Paragon maintains a dedicated suite for establishing cGMP cell banks:
The suite is segregated so that we 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.
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 24/7 security system and HVAC monitoring system. There is also an environmental monitoring program that ensures the suites are cleaned and maintained to specifications.
Cell Expansion, Harvest and Cryopreservation
Paragon is positioned to use multiple methodologies for cell expansion to manufacture a cell bank, including:
The bank can be prepared to the your specifications with regard to cell concentration and number of vials.
Vials are stored at Paragon in a validated -80C or vapor phase liquid nitrogen freezer until released to the client. The freezers are monitored electronically 24/7 on an automated notification system in case of an alarm condition.
Paragon can ship the bank directly to the client or to a specified secondary storage site.
The Paragon Quality Control and Quality Assurance Group (QA/QC) oversees the entire cell banking process from the validation of equipment to the approval of the required documents (SOPs, batch records, validation reports, etc.) to the release of the cell bank to the client.
The QA/QC Group will interact directly with your Quality representative to ensure the facility and procedures meet with your expectations as well as requirements of the appropriate regulatory authority.
As part of our Quality Assurance procedures:
All cell banks are segregated and produced on a campaign basis
Between cell banking projects Paragon deploys validated change-over and cleaning procedures
All raw materials are sourced from QA-approved vendors and released according to Paragon’s raw materials release procedures.
Prior to initiating any cell banking project, seed stock is certified as free of mycoplasma or bacteriophage, and tested for sterility.
Paragon will establish a batch record specific to your requirements:
The batch record will capture all raw materials and procedures required to establish the cell bank. Batch records are approved and finalized under client supervision.
Paragon will issue a Certificate of Analysis (CoA) upon completion of every cell banking project. The CoA includes:
All relevant manufacturing documentation
All relevant freezing documentation
All test results included in release of the bank as specified by the client
In addition to its current GMP facility, Paragon has a totally segregated new facility dedicated to virus manufacturing and research services. The 8000 square feet facility is completely separate with respect to utilities, equipment, and personnel. This facility includes a state-of-the-art process development laboratory and a newly constructed GMP suite.
The process development laboratories include two fermentation suites, several purification centers, an analytical laboratory and product storage space. The facility is also equipped with cleanroom suites dedicated to virus production (one microbial suite (40L capacity) and two mammalian virus suites (Cell expansion and production to 50L capacity), and one central downstream suite.