WACKER’s plug-and-play technology serves growing pDNA demand for cell and gene therapy

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 of these advanced therapies. Plasmid DNA can be used either directly for vaccines and gene therapies, or as starting material, e.g., 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 is the microbial CDMO – your all-in-one partner of choice for the contract manufacturing of therapeutic proteins, vaccines and live microbial products. Wacker Biotech completed a strategic acquisition in February 2021 of the former Genopis Inc. of San Diego, California, in order to include pDNA manufacturing in the above portfolio of CDMO services. Now renamed Wacker Biotech US, this site brings with it years of experience and expertise in plasmid DNA technology, which it offers to our customers via its PLASMITEC^® platform.

PLASMITEC^® is based on decades of hands-on experience in pDNA manufacturing for both early stage and Phase 3 clinical trials. As an innovative plug-and-play platform, it includes fully scalable processes as well as generation and selection of the best-performing strains to produce supercoiled and/or linearized pDNA.

Our San Diego team is highly experienced, and the staff has been manufacturing GMP-compliant pDNA at this facility since 2003, releasing over 100 GMP batches encompassing more than 10 different products. These products 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.

Wacker Biotech US operates a specialized, 650 L capacity stainless steel fermentation line for the GMP production of pDNA. In addition, 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). Additionally, Wacker Biotech operates a dedicated process development group to support feasibility, optimization, tech transfer and comparability, process characterization and validation, master cell banking, working cell banks and in-house QC & QA.