Expert Plasmid DNA Production

Wacker Biotech is your go-to CDMO expert for the production of plasmid DNA (pDNA). pDNA is the critical starting material for advanced mRNA therapies and vaccines, gene or gene-modified cell therapies, and vector-delivered therapies (e.g., AAV and LV). There are some applications, such as DNA vaccines, using pDNA as the direct therapeutic itself.

pDNA Innovation and Experience

With over 100 GMP pDNA batches produced, our San Diego center of excellence has been at the forefront of plasmid development and production for all clinical study stages, including Phase III, since 2003. We also offer these capabilities in Halle, Germany.

Our dedicated team of approximately 30 nucleic acid research scientists in Munich continuously innovates new production methodologies and technologies. Our proprietary plug-and-play PLASMITEC^® platform streamlines pDNA manufacturing with efficient fermentation and downstream purification, ensuring high-quality production without compromise.

pDNA Capabilities

Various Quality Grades
Material supply for Research Grade, High Quality and GMP Quality. For Research Grade material, our high-throughput system can screen for many different plasmids simultaneously.
Strain Development
Generation and selection of the top-performing E.coli strains for supercoiled/linearized pDNA.
Development of Customized Processes
A dedicated process development lab to support feasibility, process development and optimization as well as comparability.
Technology Transfer
Flexible and experienced MSAT teams to accommodate your customized pDNA processes.
Analytical Capabilities
Comprehensive analytical portfolio for product release, cell-based assays and stability studies.
GMP Cell Banking
Master and working cell bank production.
GMP Manufacturing
Scalable pDNA production from 43 L to 1,500 L scale including scalable lysis and dedicated lines for chromatographic purification for clinical trials or commercial supply. Learn more about our state-of-art pDNA facilities and manufacturing capabilities. Learn more about GMP Manufacturing at WACKER.
Plasmid DNA for mRNA
At its pDNA center of excellence in San Diego as well as its site in Halle, Wacker Biotech can produce template pDNA for mRNA IVT and mRNA-based therapeutics and vaccines. Click below to learn more.
Plasmid DNA for Viral Vectors
Through a partnership with Expression Manufacturing, Wacker Biotech offers viral vector capabilities. We provide the plasmids, while Expression provides the backbone technology and viral vector manufacturing. Click below to learn more.

Plasmid DNA for mRNA Plasmid DNA for Viral Vectors

Key Benefits of Wacker Biotech’s pDNA Services

Extensive Track Record
Over 20 years of experience in manufacturing plasmids for all stages of clinical studies, with more than 100 GMP pDNA batches produced.
Scalability
Seamless transitioning from 43 L up to 1,500 L for maximum flexibility throughout your product’s lifecycle.
End-to-End Capabilities
Full manufacturing chain coverage for nucleic acid-based therapies, from pDNA to mRNA to LNP.
Innovation and Know-How
Novel plasmid designs, cutting-edge pDNA production technologies, scalable processes, and ongoing strain development.
Efficiency and Speed-to-Market
Our PLASMITEC^® platform for efficiently producing complex plasmids, speeding project turnarounds, and streamlining regulatory filings.

Ready to Partner with Us?

Discover how Wacker Biotech can transform your biopharmaceutical production. Contact us today to learn more about our innovative solutions and how we can help you achieve your goals. Reach out to our team for more information.

Product/Customer Spotlights

Engensis for Helixmith

Customer: Helixmith
Product: Engensis
Scope: Production of plasmid DNA for the expression of hybrid human hepatocyte growth factor (HGF)

For Helixmith, a gene therapy biotech headquartered in Seoul, South Korea, the San Diego site of Wacker Biotech manufactured Engensis (VM202), a DNA plasmid containing novel genomic cDNA hybrid human hepatocyte growth factor (HGF) for treating diabetic neuropathy through angiogenesis and nerve regeneration. VM202 is also now being investigated as a means of regrowing motor neurons in muscle cells for ALS patients. The FDA granted regenerative medicine advanced therapy designation to Engensis in 2018, and Wacker Biotech proceeded to produce GMP batches for clinical trials in its 650 L stainless steel fermenters, followed by downstream purification.

A partnership with WACKER, one of the world’s leading microbial drug CDMOs, provides a significant boost to Helixmith. Having a strong partner like WACKER provides us with additional confidence as we pursue our global blockbuster pipeline.

Seungshin Yu, CEO of Helixmith

Saliogase for SalioGen

Customer: SalioGen Therapeutics
Product: SGT-1001
Scope: Production of plasmid DNA for mRNA-based therapeutic

For SalioGen Therapeutics, the San Diego site of Wacker Biotech manufactured a preclinical supply of GMP plasmids for an mRNA gene therapy product to treat Stargardt’s disease, a genetic disease causing blindness for which no approved therapies exist. The product’s goal was to encode for a bioengineered enzyme called Saliogase to execute highly precise gene editing once in the target cell – in this case retina cells in the eye. One of the plasmids that Wacker Biotech produced encoded for a long poly-A tail.

"The partnership between SalioGen and Wacker exemplified the core values of our industry: collaboration, transparency, trust, and resilience. WACKER’s expertise with plasmid DNA manufacturing was critically important. They consistently demonstrated a commitment to seeing projects through to completion for SalioGen. Both parties deeply appreciate the mutual dedication and experience that defined this collaboration."

Jason Cole, CEO, SalioGen Therapeutics, Inc.

BioBlood for ArtBlood

Customer: ArtBlood
Product: BioBlood
Scope: Production of lentiviral plasmids for a viral vector-delivered cultured blood product

For ArtBlood, a Korean biotech company and pioneer in ex vivo blood production, the San Diego site of Wacker Biotech used its proprietary PLASMITEC platform to supply the gene of interest plasmid plus packaging and envelope plasmids for ArtBlood’s cultured red blood cell product. The plasmids were then shipped to Expression Manufacturing for viral vector manufacturing of the drug product for clinical development.