pDNA Production & Purification

Setting the Standard for pDNA Production

Boehringer Ingelheim BioXcellence™ is one of the world's leading contract manufacturers for non-viral plasmid DNA (pDNA) produced by microbial fermentation. With an innovative and strictly quality-driven process design, we provide pDNA in lot sizes ranging from the multi-gram to the kilogram scale.

Our platform technologies in fermentation and the generic process steps in downstream processing, as well as a versatile analytical concept enable reduced time to clinic and time to market, thereby offering a reduction in the cost of goods during development.
Boehringer Ingelheim BioXcellence™ already has a validated process and a production track record in place. We have produced more than 30 different plasmids at the lab scale, more than 20 plasmids under cGMP conditions and more than ten plasmids for clinical studies up to Phase III for more than ten different customers. Our expertise ensures robust and reproducible production and high product quality. Our experience with different E. coli hosts and pDNA-sizes in the range of 2 – 15 kbp, a modular purification process, and ready-to-use documents provide high flexibility for the production of pDNA according to our clients’ needs for various therapeutic or prophylactic applications.

The process format results in high product purity and high yield, thus ensuring efficiency and quality. The broad and Intellectual Property (IP)-covered production experience is offered royalty free to our customers.

In addition, Boehringer Ingelheim BioXcellence™ also provides formulation development, fill and finish and regulatory support for pDNA therapeutics and vaccines.

Your benefits at a glance:

• Proprietary ready-to-use pDNA process platforms: upstream, downstream, fill and 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
• High fermentation titers > 3 g pDNA/L
• Scalable cell lysis enabled by an automated continuous system
• Innovative purification steps free of enzymes, organic solvents and detergents
• High downstream yields > 50%
• Maintenance of supercoiled plasmid conformation (up to 98%)
• Broad Intellectual Property (IP), expertise and a good client track record in pDNA manufacturing