pDNA: Wacker Biotech’s Plug-and-Play Platform

The demand for nucleic acid-based gene therapies, novel vaccines, innovative therapeutic agents including messenger RNA (mRNA) and viral vectors is high. Plasmid DNA (pDNA) is the basis for all these advanced therapies. Wacker Biotech’s versatile plug-and-play platform is based on decades of hands-on experience in pDNA manufacturing for both early stage and Phase III clinical trials.

Plasmid DNA

Wacker Biotech’s production site in San Diego serves as the location for cGMP manufacturing operations and is equipped with a 30 L single-use bioreactor and a 500 L stainless steel fermentation vessel, including scalable cell lysis. The company's approximately 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).

Plug-and-Play Platform

Wacker Biotech as a contract development and manufacturing organization (CDMO) supports its customers throughout the entire product lifecycle, right up to commercialization. Developed over decades, our plug-and-play platform for pDNA manufacturing offers great recovery and reliability, but also a highly flexible approach: we meet your needs and scale up, e.g. by adjusting fermentation and lysis conditions.

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 30 L and 500 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

Production Process

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.

Outstanding Experience

Accumulated experience of more than 18 years in manufacturing plasmids as DS and DP for all stages of clinical studies, including but not limited to Phase III

  • Fully equipped to produce GMP-grade pDNA to meet the highest quality standards and regulatory compliance
  • Extensive know-how in cutting-edge pDNA production technologies including fully scalable processes due to scalable lysis approach
  • Over 100 GMP pDNA batches produced
  • High-quality GMP pDNA for various client applications:
    • Viral vectors (AAV, lentivirus)
    • DNA vaccines
    • CAR-T cell therapy
    • Gene editing
    • mRNA production

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