WACKER offers Contract Research Services (CRS) for nucleic acid-based pharmaceuticals

• The new CRS expand WACKER’s offering for biotech and biopharmaceutical customers worldwide and complement Wacker Biotech’s CDMO services.
  
  
• The Munich team at the WACKER Biotechnology Center provides research-quality pDNA, RNA and lipid nanoparticles (LNPs) for preclinical studies.
  
  
• Integrated services for faster development: Projects can be seamlessly scaled up and transferred to Wacker Biotech’s global GMP network for clinical supply.
  
  

WACKER is introducing Contract Research Services (CRS) for biotech and biopharmaceutical customers worldwide. This new offering complements the contract development and manufacturing services provided by WACKER subsidiary Wacker Biotech, a CDMO (Contract Development and Manufacturing Organization) for biologics with GMP (Good Manufacturing Practice) sites in Germany (Halle, Jena), the Netherlands (Amsterdam), and the United States (San Diego).

The CRS are provided by a dedicated team of scientists at the WACKER Biotechnology Center, a state-of-the-art facility that opened last year on the corporate research campus in Munich. The team supports customers in the production of small quantities of research-grade plasmid DNA (pDNA), RNA (ribonucleic acid), and lipid nanoparticles (LNPs) for preclinical in vitro and in vivo studies, with a clear pathway for subsequent scaling up to GMP-compliant clinical supply.

From structural design and preclinical material to GMP manufacturing

In addition to the production of pDNA, RNA, and LNP formulations, WACKER’s CRS team offers construct design services, including the design of plasmid and RNA constructs, as well as RNA engineering and optimization through established partners (UTR, poly(A), and cap optimization). The scientists also perform lipid library screening and the formulation of lipid nanoparticles, and offer functional assays and analytical services.

By integrating early-stage R&D support with a globally networked GMP manufacturing network, CRS helps customers optimize development and reduce supply chain fragmentation. This approach enables faster design-to-delivery development for innovative, next-generation therapies while simultaneously reducing risks and costs through flexible resource provision in early stages and scalable transfer to Wacker Biotech for high-quality clinical material.

Sound expertise in the field of nucleic acids

The CRS team is the same group of experts behind PLASMITEC®, WACKER’s platform and proprietary E. coli strain for pDNA production. In addition, the team has conducted more than 100 collaborations with academic partners and consortia. It has extensive experience with RNA modalities underlying many advanced therapeutics and vaccines currently under investigation, including mRNA, circular RNA, and self-amplifying RNA (saRNA).

“Every RNA or LNP project is unique. Our goal is to offer flexible, customized services that adapt to the specific needs of our clients in a dynamic environment. All too often, innovative, potentially life-saving therapeutic concepts fail right from the start because developing even small quantities of active pharmaceutical ingredient for research and development is associated with high costs. Our contract research services enable us to serve highly specialized clients – especially small start-ups – with competitive prices and timelines,” said Christian Dubiella, Global Program Manager CRS at WACKER.

One of the first customers is SRTD Biotech GmbH. Bernd Hoffmann, CEO/CSO and co-founder of SRTD, said: “As an emerging biotech company, we begin developing new therapeutic approaches on a small scale. Our seRNA (selectively expressed RNA)-based platform technology can be easily adapted to numerous therapeutic areas by leveraging the transcriptome for selective cell targeting and fusogenic LNPs for organ-specific targeting. With its extensive expertise and resources, WACKER is an ideal partner on the path to realizing our vision of providing patients with seRNAs to improve their lives. The CRS help us accelerate the journey from design to delivery.”

WACKER plans to further expand its contract research activities. The next step will involve adding protein-based contract research systems (CRS) to its existing offerings for nucleic acid-based vaccines and therapeutics.