Plasmid DNA Production at Boehringer Ingelheim BioXcellence™
Setting the standard
Gene vaccinations and gene therapies are setting new standards in quality, safety, yield and speed. They may still be experimental, but DNA vaccines have been applied to viral, bacterial, and parasitic diseases as well as several types of tumors. As delivery systems have improved over the last decade and a half, clinical trials have risen to around 100 per year.
We're well aware of the potential benefits to our customers, which is why we have developed a proven production process for high-quality plasmid DNA (pDNA).
High quality, rapid results
The result is rapid turnaround of high-quality products: up to 98% monomeric ccc plasmid conformation and excellent content per gram – up to 60 mg/g dry cell weight of E. coli biomass - available for clinical trials within 12 months. Our E. coli host reaches higher fermentation titer concentrations than conventional strains, at up to 3.2 g/L; in GMP production, we can obtain up to 50 g of drug substance per batch.
With patient safety as our utmost priority, we have invested in proprietary technology to produce plasmids without antibiotics and free from animal-derived or complex components. Our antibiotic resistance-free plasmid production strategy also in accordance to regulations from international health authorities for the manufacturing of highly pure pDNA.
From concept to product
All this is available as a fast-track service from project start to clinic or commercialization, generating products that meet all regulatory requirements; our specialist microbial fermentation site in Vienna offers various scales. Feasibility studies producing milligram quantities at laboratory scale can be completed with two months and pilot-scale, gram-quantity production for toxicology studies within six. Within 12 months, production of highly purified, GMP-grade pDNA can be achieved.
Our production offer spans the entire process chain, from transformation of the host cell to clinical and market supply: cell banking, process development and scale-up, fill and finish, and quality and regulatory services.
Safety and quality
With our proprietary Boehringer Ingelheim E. coli host and our fed-batch process, we achieve titers at up to 3.0 g/L using high copy number pUC or plasmids with similar origins of replication (ORIs). Furthermore, we offer induction-free high cell density fermentation in defined media with a pDNA content of up to 60mg/g cells, which due to our high quality downstream purification results in very low endotoxin levels.
This robust platform process yields product of highest quality and safety, monitored by the full range of analytical methods, including fast, sensitive methods, developed in-house, based on AIEX-HPLC and agarose gel electrophoresis.
A history of success
To date, we have helped to create:
- 35+ different plasmids at both laboratory and large scale
- 25 pDNAs at GMP scale for clinical trials up to commercial supply
- 20+ plasmids in our proprietary E. coli host with titers up to 3.0 g/L
With our pDNA production platform, we have gained the trust of over a dozen (and counting) worldwide customers and we will keep exploring the new frontiers of pDNA development and production.