WACKER BIOTECH is “THE MICROBIAL CDMO” – your partner of choice for process development and contract manufacturing of biopharmaceuticals (proteins, vaccines, live microbial products, plasmid DNA (pDNA)) using microbial hosts. Additionally, WACKER BIOTECH provides R&D and GMP manufacturing services for advanced therapies as a one-stop-shop: from the production of plasmid and template DNA as starting material for mRNA through the IVT of mRNA and LNP formulation, the nucleic acid expertise of Wacker Biotech combined with the lipid expertise of our partner CordenPharma ensures the best possible results for each of our client’s mRNA-focused projects.
WACKER BIOTECH’s integrated service portfolio covers molecular biology, process / analytical development as well as GMP manufacturing of biologics for clinical and commercial supply.
WACKER BIOTECH operates four state-of-the-art GMP facilities located in the U.S., Germany and The Netherlands. Manufacturing lines are equipped with stainless steel fermentation vessels from 350 to 1500 liter as well as single-use bioreactors. Matching primary recovery, downstream and Fill & Finish capabilities are available to suit various clients’ needs across the development path (BSL 1 and 2). Additionally, a GMP cell-bank suite enables independent cell-bank production and storage capacity for client cell banks.
In 2022 the German government selected Wacker Biotech and CordenPharma as joint bidders for the stand-by production of vaccines based on mRNA. Therefore, WACKER is now building a state-of-the-art mRNA competence and manufacturing center at its existing Halle, Germany site to complement its other existing sites in Jena, Germany, Amsterdam, the Netherlands and San Diego, California. The new capabilities at Wacker Biotech Halle will support end-to-end manufacturing of plasmid DNA, mRNA and LNP formulation under one roof.
WACKER BIOTECH holds biomanufacturing certificates from the relevant authorities for all sites and follows the ICH Q7A guidelines for GMP-compliant production of biologics. The GMP production facilities in the Netherlands and Germany are approved by the EMA, U.S. FDA and/or ANVISA for commercial manufacturing. The WACKER BIOTECH U.S. site is currently preparing for a U.S. FDA inspection.
Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly-owned subsidiaries of Munich-based Wacker Chemie AG.
WACKER BIOTECH’s integrated service portfolio covers molecular biology, process / analytical development as well as GMP manufacturing of biologics for clinical and commercial supply.
WACKER BIOTECH operates four state-of-the-art GMP facilities located in the U.S., Germany and The Netherlands. Manufacturing lines are equipped with stainless steel fermentation vessels from 350 to 1500 liter as well as single-use bioreactors. Matching primary recovery, downstream and Fill & Finish capabilities are available to suit various clients’ needs across the development path (BSL 1 and 2). Additionally, a GMP cell-bank suite enables independent cell-bank production and storage capacity for client cell banks.
In 2022 the German government selected Wacker Biotech and CordenPharma as joint bidders for the stand-by production of vaccines based on mRNA. Therefore, WACKER is now building a state-of-the-art mRNA competence and manufacturing center at its existing Halle, Germany site to complement its other existing sites in Jena, Germany, Amsterdam, the Netherlands and San Diego, California. The new capabilities at Wacker Biotech Halle will support end-to-end manufacturing of plasmid DNA, mRNA and LNP formulation under one roof.
WACKER BIOTECH holds biomanufacturing certificates from the relevant authorities for all sites and follows the ICH Q7A guidelines for GMP-compliant production of biologics. The GMP production facilities in the Netherlands and Germany are approved by the EMA, U.S. FDA and/or ANVISA for commercial manufacturing. The WACKER BIOTECH U.S. site is currently preparing for a U.S. FDA inspection.
Wacker Biotech GmbH, Wacker Biotech B.V. and Wacker Biotech US Inc. are wholly-owned subsidiaries of Munich-based Wacker Chemie AG.
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