Wacker Biotech is the all-in-one CDMO partner of choice for process development and manufacturing of advanced therapies and vaccines, as well as live biotherapeutic products (LBP) and recombinant proteins based on microbial systems. Our advanced therapies capabilities span the full manufacturing chain, from the production of plasmid and template DNA as a starting material for mRNA through the IVT of mRNA to lipid nanoparticle (LNP) formulation. We have the capability to produce at diverse scales up to 1500 L and recently quadrupled our mRNA production capacity with the completion of a new mRNA competence center in Halle, Germany. Complementing our bioprocess development and manufacturing experts at our five global sites is a team of approximately 30 dedicated research scientists at our parent company’s R&D hub in Munich, Germany. This team leads continuous innovations in pDNA manufacturing, mRNA production, LNP formulation, and analytical development.

Type of Drugs Manufactured:

Biologics;Cell & Gene Therapy

CDMO Services offer:

Drug Substance Manufacturing (API);Research & Development;Analytical Development

No. of Manufacturing Facilities:

3-5

Facilities Locations:

Europe;North America

Regulatory Approvals for facilities:

FDA (United States);EMA (Europe);ISO;GMP;PMDA (Japan);Health Canada;ANVISA (Brazil)

Manufacturing Technologies:

Liquids;Sterile Vials

Current Capacity:

Wacker Biotech stands out in the biopharmaceutical landscape for its exceptional capabilities and commitment to quality, making it a valued partner for numerous pharmaceutical companies. For more information, please visit wacker.com/biologics.