(BRIEF) WACKER is strategically strengthening its Life Sciences BIOSOLUTIONS department by strengthening its functions in the biopharmaceuticals for complex therapeutics sector. Its subsidiary, Wacker Biotech US, founded in San Diego, is expanding mRNA and protein production to meet the growing demand for contract production facilities in the gene therapy space. With a focus on setting rigorous regulatory and quality standards, adding to the cGMP compliance set by the FDA, Wacker Biotech US is strengthening its fermentation and downstream processing functions. The expansion includes new laboratories for the advancement of bioprocessing. for pDNA, mRNA, and recombinant proteins, positioning WACKER to meet the changing desires of clinical studies and progression in the U. S. market. In the U. S. and beyond.
(PRESS RELEASE) MUNICH, May 6, 2024 — /EuropaWire/ — As part of its expansion strategy for the BIOSOLUTIONS life sciences division, WACKER is expanding its functions in the biopharmaceuticals for complex therapeutics sector. Wacker Biotech US, a subsidiary specializing in the fermentation production of plasmid DNA (pDNA), is expanding its production of mRNA and proteins. As a contract manufacturer (CDMO) in San Diego, USA, Wacker Biotech is committed to complying with strict quality standards and existing Good Manufacturing Practices (cGMP). U. S. Food and Drug Administration (FDA) criteria.
Driven by advances in the field of gene therapy, the demand for CDMOs providing end-to-end other components for nucleic acid-based gene treatments has increased sharply in recent years.
Wacker Biotech US Inc. , a wholly-owned subsidiary of Wacker Chemie AG, specializes in the microbial production of pDNA. As a CDMO in the tough biotech hub of San Diego, the company offers several fermentation lines with a capacity of up to 650 liters of fermentation. and the following subsequent processing steps.
Wacker Biotech US is now building more progression and production functions in the field of complex treatment drugs to be able to offer complete answers to the U. S. market. By commissioning new labs, Wacker Biotech US is expanding its bioprocess progression capabilities for pDNA, mRNA, and recombinant proteins to preclinical studies and progression. This service preferentially complements the nucleic acid expertise of this site. At the same time, Wacker Biotech US has effectively demonstrated that pharmaceutical proteins can be produced at a scale of 650 L of cGMP at the San Diego facility. .
Thanks to the expansion of functions and the consequent transfer of decades of experience from Wacker Biotech’s European facility to San Diego, recombinant messenger RNA (mRNA) and proteins can now be produced to meet the needs of clinical studies and development.
Managing Director of Wacker Biotech USA, Dr. Philippe Cronet, says: “We have strong local expertise in the production of pharmaceutical proteins and derive advantages from the many years of experience of Wacker Biotech’s global team. Our facility is conveniently located in one of the vital biotech hubs, allowing us to serve the local and broader market in the United States, but also around the world.
Wacker Biotech, a subsidiary of WACKER, has been generating healing proteins, live microbial products, vaccines, and mRNAs for clinical progression and source advertising at its Jena, Halle, and Amsterdam sites for decades. Wacker Biotech US’s proprietary pDNA generation complements WACKER’s portfolio as a contract manufacturer for the pharmaceutical industry. With its location in San Diego, WACKER has been present in the vital U. S. biopharmaceutical market. Since 2021, WACKER has been investing frequently in its biopharmaceutical business.
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SOURCE: Wacker Chemie AG
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