Producing purified plasmid DNA

INGELHEIM, Germany—Boehringer Ingelheim, a leader in the production of plasmid DNA, and GENEART AG, a gene design and synthesis specialist, announced a technology and sales collaboration late last month. The collaboration includes a transfer of Boehringer Ingelheim technology to GENEART for the production and purification of plasmid DNA. The two companies also plan to closely collaborate in the distribution and marketing of their complementary services.

The deal allows the companies to offer a unique system solution for the development of DNA-based pharmaceuticals. Regensburg, Germany-based GENEART will use Boehringer Ingelheim's production and purification technology to deliver DNA-based agents for research, development and preclinical studies. Boehringer Ingelheim will produce the pharmaceuticals under cGMP (current Good Manufacturing Practice) conditions for the subsequent clinical phases and the market. Customers in research and industry additionally benefit from GENEART's expertise in software-assisted design of gene sequences and from the production of these improved (optimized) sequences via gene synthesis. Optimized genes are essential for the improvement of product properties, such as for the enhancement of immunogenicity and safety of DNA-based pharmaceuticals.

"The collaboration with Boehringer Ingelheim opens new horizons to support customer projects in the fast-growing market for DNA-based therapeutics and vaccines. Optimized pharmaceutical agents will be readily available in consistent quality for every development phase either from GENEART, or from Boehringer Ingelheim, respectively, says Professor Dr. Ralf Wagner, CEO of the GENEART. "This also applies to the necessary quantities for clinical trials or for the product launch. Thus, this collaboration ideally meets the requirements of the regulatory agencies for a consistent source of pharmaceutical agents for the entire development process. Therefore, our customers can avoid unnecessary and expensive delays caused by repeated studies to prove consistent agent quality."

Rolf G. Werner, senior VP of the Boehringer Ingelheim corporate division biopharmaceuticals, elaborates: "GENEART perfectly complements our services for the development and production of plasmid-DNA for use in clinical trials and for the market.

The transfer of technology from Boehringer Ingelheim to GENEART offers flexible access to optimized DNA agents and the benefit of an economic production technology to a broad clientele in R&D. The consistent production procedures help our customers to significantly shorten the time to market for new innovative DNA-based therapeutics and vaccines." DDN