WACKER’s mRNA competence center in Halle is to produce an active ingredient based on mRNA and lipid nanoparticles (LNPs) for combating acute respiratory distress syndrome (ARDS).

Manufacture of the PAN004 active ingredient supplied by Pantherna Therapeutics, a biotech company, is based on a large-scale production process developed by WACKER for mRNA formulated in LNPs. This makes Pantherna WACKER’s first partner to receive preclinical material from its state-of-the-art production plant, which is set to go on stream in mid-2024.

WACKER covers the entire production process – from starting material and plasmid DNA through to the mRNA LNP formulation and dispensed mRNA active.

A competence center for active ingredients based on messenger ribonucleic acid (mRNA) will soon open at WACKER’s site in Halle. This site features four new production lines that Wacker Biotech GmbH, a fully owned subsidiary of Wacker Chemie AG, will use to contract manufacture mRNA vaccines, among other things. Part of the new capacity will be available to the German federal government as and when required as part of its pandemic preparedness contracts. Pantherna is the first partner to be supplied by the new facility in Halle.

Dr. Guido Seidel, Managing Director, Wacker Biotech GmbH, said: “Early collaboration with Pantherna made it possible to develop a cost-effective and scalable process. This doesn’t often happen during preclinical stages in a CDMO setting. Close collaboration with our experts in Corporate R&D was the key to success here. The transfer of technology to our new production facility is now moving at full speed and we are certain that Pantherna will benefit from our manufacturing expertise.”

Dr. Jörg Kaufmann, CSO, Pantherna Therapeutics, said: “We have established a very good collaborative R&D footing with WACKER and value its broad expertise in the production of mRNA active ingredients – expertise that we were able to use to turn our innovative technology into a product. WACKER plays a special role in the market, as it combines many years of experience in the toll manufacturing of complex biopharmaceuticals with the capabilities of its own Corporate R&D unit. We are delighted to now see our innovative mRNA active ingredient move from the laboratory to regulated production. This marks an important milestone for our company and opens a new chapter in our joint collaboration.”

With sites in Halle, Jena, Amsterdam and San Diego, Wacker Biotech is a CDMO for the GMP-compliant production of active ingredients for the pharmaceutical industry.

Pantherna and Wacker Biotech have been collaborating since 2022. As part of a joint research project, both companies initially developed the manufacturing process for mRNA-based active ingredients using WACKER’s own process.