Pioneers in plasmid DNA production
Gene vaccinations and gene therapies have set new standards. Plasmid DNA (pDNA) has turned into a key factor for successful research, development and commercialization of potentially game changing products.
We, at Boehringer Ingelheim, are pioneers in the manufacturing of pDNA. We have developed and continuously improved a best in class production process for highest-quality pDNA to leverage the potential of new therapeutic or prophylactic applications for our customers. As one of the world's leading contract manufacturers, Boehringer Ingelheim BioXcellence™ can provide pDNA from research to GMP grade in lot sizes ranging from multi-grams to kilograms.
Our platform technologies in E. coli host strain development, fermentation, and downstream processing, as well as a versatile analytical concept enable fast time to clinic and time to market. Our sound technical expertise combined with high quality and regulatory competence has satisfied more than 14 different customers around the world with pDNA of various sizes.
Production process for plasmid DNA:
- Proprietary ready-to-use pDNA platform process: strain development, upstream and downstream, Fill & Finish
- Custom-designed solutions for genetic host / vector engineering
- Well characterized E. coli host strain ensuring a high ratio of supercoiled pDNA
- High-cell-density cultivation process up to 6,000 L bioreactor scale
- High upstream titers (concentrations up to 3.2 g/L with Boehringer Ingelheim’s E. coli host for plasmid production)
- Automated, continuous and scalable cell lysis
- Robust recovery and purification steps free of enzymes, organic solvents and detergents
- High downstream yields > 50%
- Maintenance of supercoiled plasmid conformation (up to 98%)
- High purity and animal component free
- Broad Intellectual Property (IP) and deep process understanding royalty free for our customers
Competitive plasmid DNA track record:
- More than 35 different plasmids from 2–15 kbp at laboratory and GMP large scale
- 25 pDNAs produced at GMP scale for clinical trials from phase I to commercial supply
- More than 14 different customers all over the world
- More than 20 plasmids produced in Boehringer Ingelheim E. coli host resulting in titers up to 3.2 g/L and a supercoiled ratio up to 98%
In addition, Boehringer Ingelheim BioXcellence™ has a validated process and a proven track record in pDNA manufacturing and provides regulatory support for pDNA therapeutics and vaccines.