In pursuit of its growth strategy for the BIOSOLUTIONS life-science division, WACKER is ramping up capacities in the biopharmaceutical realm, particularly for advanced therapies. Wacker Biotech US, a subsidiary specializing in fermentative production of plasmid DNA (pDNA), is broadening its scope to include mRNA and protein production. Situated in San Diego, USA, this subsidiary adheres strictly to the rigorous quality and regulatory standards set by the US Food and Drug Administration (FDA) under Current Good Manufacturing Practices (cGMP).
The surge in demand for Contract Development and Manufacturing Organizations (CDMOs) providing end-to-end services for nucleic acid-based gene therapies, driven by advancements in gene therapy, has been notable in recent years.
Wacker Biotech US Inc, a wholly owned subsidiary of Wacker Chemie AG, is a key player in the microbial production of pDNA. Nestled within the thriving biotech hub of San Diego, the company boasts several fermentation lines with capacities reaching up to 650 liters, followed by downstream processing steps.
Presently, Wacker Biotech US is augmenting its development and production capabilities in advanced therapy medicinal products, aiming to offer holistic solutions to the US market. By launching new laboratories, the company is enhancing its bioprocess development capacities for pDNA, mRNA, and recombinant proteins, thereby bolstering support for research and pre-clinical development. This service seamlessly complements the nucleic acid expertise of the site. Additionally, Wacker Biotech US has successfully demonstrated the production of pharmaceutical proteins at a cGMP scale of 650 liters at its San Diego facility.
With the capacity expansion and the transfer of decades of expertise from Wacker Biotech’s European sites to San Diego, production of messenger RNA (mRNA) and recombinant proteins now aligns with the demands of research and clinical development.
Dr. Philippe Cronet, General Manager of Wacker Biotech US, comments: “Our local proficiency in pharmaceutical protein production, combined with the extensive experience of the global Wacker Biotech Team, positions us strongly. Situated in one of the most vital biotech hubs, our site enables us to cater to the local US market as well as global demands.”
For decades, WACKER’s subsidiary, Wacker Biotech, has been manufacturing therapeutic proteins, live microbial products, vaccines, and mRNA for clinical development and commercial supply at its sites in Jena, Halle, and Amsterdam. Wacker Biotech US’ proprietary pDNA technology enriches WACKER’s portfolio as a contract manufacturer for the pharmaceutical industry. Since 2021, with its San Diego site, WACKER has had a significant presence in the crucial US market for biopharmaceutical products and remains committed to continuous investment in its biopharma business.
