The global demand for nucleic acid-based gene therapies, novel vaccines, and innovative therapeutic agents including messenger RNA (mRNA) and viral vectors is extremely high and projected to increase in the future. Plasmid DNA (pDNA) is the basis for all these advanced therapies as it can be used either directly for gene therapies and vaccines, or as starting material, for example to manufacture mRNA. The CDMO market for pDNA is expected to grow by 19 percent by 2025 (Global Viral Vector and Plasmid DNA Manufacturing Market Research Report). Wacker Biotech US offers decades of experience and expertise in all aspects of pDNA technology.
Wacker Biotech is the microbial CDMO – your all-in-one partner of choice for the contract manufacturing of therapeutic proteins, vaccines, live microbial products and plasmid DNA. Wacker Biotech’s end-to-end services cover project management, process development, cell banking and microbial strain engineering, analytical development, GMP manufacturing of biologics, QA oversight, and process characterization.
From our Wacker Biotech B.V. site in Amsterdam, we offer innovative technologies for the efficient and cost-effective production of live microbial products and microbial vaccines as well as fill and finish drug product services. At our Wacker Biotech GmbH sites in Jena and Halle, Germany, we offer ESETEC® Controlled Secretion and FOLDTEC® Protein Folding technologies. two unique E. coli-based production systems patented and developed by Wacker Biotech that significantly increase bioprocess efficiency and lower the cost of goods.
To complement the above portfolio of CDMO services, Wacker Biotech completed a strategic acquisition in February 2021 of the former San Diego, California-based company Genopis Inc. Now recognized as Wacker Biotech US, this site brings with it years of experience and expertise in plasmid DNA technology to support our customers. Our San Diego team is highly experienced and the staff has been manufacturing GMP-compliant pDNA at this facility since 2003, with over 100 GMP batches released, encompassing more than 10 different products. These have been utilized by governmental and commercial entities in various client applications such as viral vectors (AAV, lentivirus), DNA vaccines, CAR T-cell therapies, gene editing, and mRNA production. This acquisition also establishes a local manufacturing site and presence in the US for Wacker Biotech to serve the biologics market in this region.
Wacker Biotech US operates a specialized, 500 L capacity stainless steel fermentation line for the GMP production of pDNA. Further small-scale lines that feature single-use fermentation technologies are being validated for additional capacity, with significant room for expansion. Corresponding single-use lysis and single-use purification capabilities are available to suit various client manufacturing needs along the clinical path including the supply of R&D material.
We offer extensive know-how in cutting-edge pDNA production technologies including fully scalable processes, 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 along with QC and QA release in-house.
Plasmid Manufacturing with Wacker Biotech US - Key Takeaways:
- Highly scalable platform pDNA manufacturing process
- In-house QC/QA to expedite product release
- Capacity for GMP manufacturing available at 500-L scale (stainless)
- Additional capacity for GMP manufacturing available in 2022 at up to 30L (single use)
- Planned installation of additional single-use GMP line to fit future customer needs
- Several yield, quality, and regulatory options available
- Comprehensive services for plasmid manufacturing, QC testing, and QA release
Our versatile pDNA Plug-and-Play platform is based on decades of hands-on experience in pDNA manufacturing for both early stage and Phase 3 clinical trials. A combination of innovative technologies, quality systems, outstanding experience and the ability to efficiently perform GMP (Good Manufacturing Practice) production for both clinical studies and future commercial purposes make Wacker Biotech US, Inc. the partner of choice for the contract manufacturing of pDNA.