GMP Plasmid DNA

Waisman's platform plasmid manufacturing process yields up to multi-gram quantities of clinical, CGMP grade plasmid DNA that can be used for direct injection or ex-vivo/further manufacturing applications. Waisman has delivered plasmid DNA vaccines up to Phase 2 clinical trials and can support Phase 3/commercial for plasmid DNA used as an ancillary material. 

Plasmid Production Specifics

• Clone optimization and Master/Working Cell bank production and testing
• CGMP production of multi-gram batches for direct injection and ancillary use
• 30-120L steam-in-place fermentor capacity
• Scalable manufacturing process free of organic solvents and animal derived products
• Quality Control testing including HPLC and qPCR
• In-house development of custom potency assays

GMP Plasmid Highlights

• High yield fermentation
• No animal derived enzymes or organic solvents
• Scalable production process
• Milligram to multi-gram capacity
• DNA vaccines, ex vivo or bioprocess manufacturing applications

Plasmid DNA Quality Control Methods

Waisman's platform plasmid DNA manufacturing process has been designed to exceed regulatory requirements for percent supercoil and host impurities. Custom potency assays can also be developed in addition to the standard methods below.