From Mind To Market - Boehringer Ingelheim

14
We have the technology
Setting the standard for pDNA production
Gene therapy and gene vaccines have been
moving out of the research laboratory and into
the clinic. These techniques promise to revolutionize
the treatment of a wide variety of
diseases. In order to meet the growing need for
pharmaceutical grade plasmid DNA (pDNA),
Boehringer Ingelheim RCV GmbH & Co KG has
developed a production process for pDNA utilizing
state-of-the-art technology. This process
employs high cell density fermentation, followed
by gentle cell lysis and a powerful downstream
process to produce pDNA of greater than 99 per
cent purity with very low levels of endotoxin and
genomic DNA. In addition, a host-vector system
is available which enables antibiotic-free selection
of small plasmid vectors devoid of antibiotic
resistance genes. By using this industrial pDNA
manufacturing technology no toxic organic solvents,
animal-derived enzymes or antibiotics are
necessary. To ensure the safety and functionality
of the product analytical methods have been
developed for both in-process control and final
product release that can detect all forms of DNA
and potential impurities.
The outstanding performance of this new process
allows upscaling of the fermentation and
purification process to large volumes under full
cGMP. The highly competitive process, which was
awarded with the Frost and Sullivan Technology
Leadership Award, is proprietary to Boehringer
Ingelheim and applied royalty-free for pDNA
production for our worldwide clients.