Master and Working Cell and Virus Banks
Paragon Gene Therapy offers master and working cell and virus banking services either as part of a larger cGMP production run or contracted as an individual project. Segregated cell banking suites are maintained for microbial and mammalian production.
We maintain dedicated suites for establishing cGMP cell banks, which are segregated so that we can serve customers requiring either mammalian or microbial cell banks. We are positioned to use multiple methodologies for cell expansion to manufacture a cell bank, including T-flasks, cell factories, roller bottles, shake flasks, and spinner flasks.
The banks can be prepared to your specifications with regard to cell concentration and batch size. Vials are stored at Paragon in a validated -80C or vapor phase liquid nitrogen freezer until released to the client. Paragon can ship the bank directly to the client or to a specified secondary storage site.
In addition, our new manufacturing facility offers totally segregated areas dedicated to virus manufacturing and research services. The 8,000 sq. ft. facility is completely separate with respect to utilities, equipment, and personnel and includes a state-of-the-art process development laboratory and a newly constructed cGMP 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.