PLASMITEC^®: Wacker Biotech’s Plug-and-Play Platform for pDNA Manufacturing

Wacker Biotech’s production site in San Diego serves as the location for cGMP manufacturing operations and is equipped with a 43 L single-use bioreactor and a 650 L stainless steel fermentation vessel, including scalable cell lysis. The company's more than 40 employees have extensive experience in the production of pDNA according to the quality guidelines of "Good Manufacturing Practice" (GMP) ranging from clinical startups to commercial product companies. pDNA can be used either directly for nucleic acid-based gene therapies and for vaccines or as a starting point for such innovative therapeutic agents, for example to manufacture messenger RNA (mRNA).

Our Services Include:

• Generation and selection of the best-performing strains to produce supercoiled/linearized pDNA
• A dedicated process development lab to support feasibility, optimization, tech transfer and comparability
• Process characterization and validation
• Master cell bank and working cell bank production
• GMP manufacturing for clinical trials or commercial supply, including:
  • Fermentation on 43 L and 650 L scale
  • Scalable lysis suited for large-scale production
  • Dedicated lines for chromatographic purification
  • Analytical portfolio for product release, cell-based assays and stability studies
  • Storage at -70 °C
  • QC and QA release in-house

In the first step of pDNA production, an initial plasmid construct is used to generate production cell banks. This is followed by fermentation in larger reactors, where the actual production of the plasmid DNA takes place. Subsequently, the cell paste produced during fermentation is harvested and the plasmid is extracted from the cell paste by a process of alkaline scalable lysis. In a multi-step purification process, the extracted pDNA molecules are then separated from undesirable components, purified and concentrated. In the final step the finished pDNA can be filled into a client’s desired container.