Plasmid cGMP Manufacturing

PackGene’s plasmid production allows for the use of existing plasmids provided by the customer, as well as the reconstitution of plasmids on request, using PackGene’s proprietary vector backbone. We also provide complete upstream and downstream process development support for specific plasmid production. We offer both research grade and GMP grade plasmids for different needs. Scientific plasmids are used for routine transfection experiments, viral transduction, gene therapy, etc. GMP plasmids are used for plasmid-based gene therapy or AAV pilot or mass production.

PackGene’s fermentation scale ranges from 50L to 200L with single-use technologies. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain isolated manufacturing conditions. We conduct a full room changeover after finishing one batch.

PackGene produces plasmids in 1L-50L fermentation systems using “single-use technology”. The plasmid production process is done in a separate dedicated production room, which is physically separated from other plasmid and plasmid bearing materials to maintain separate and clean production conditions.

After each batch of specialty service is completed, we clean and maintain the entire room facility, including thoroughly cleaning surfaces and all non-disposable equipment, prior to the start of the next GMP plasmid program, and we use disposable materials for most critical procedures, significantly reducing the chance of contamination of the specialty service.