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WACKER launches Contract Research Services (CRS) for nucleic acid-based medicines
WACKER is launching Contract Research Services (CRS) for biotech and biopharma customers worldwide. The new offering complements the contract development and manufacturing services of WACKER subsidiary Wacker Biotech, a biologics CDMO with GMP (Good Manufacturing Practice) sites in Germany (Halle, Jena), the Netherlands (Amsterdam) and the United States (San Diego).
WACKER’s Biotechnology Center in Munich provides Contract Research Services (CRS) for R&D-grade pDNA, RNA and LNPs for preclinical studies. Source: WACKER
CRS are delivered by a dedicated team of scientists based at the WACKER Biotechnology Center, a state-of-the-art facility opened last year on the group’s corporate R&D campus in Munich. The team supports customers with R&D-grade production of small quantities of plasmid DNA (pDNA), RNA (ribonucleic acid) and lipid nanoparticles (LNPs) for preclinical in vitro and in vivo studies, with a clear pathway for later scale-up to GMP clinical supply.
In addition to producing pDNA, RNA and LNP formulations, WACKER’s CRS team offers construct design services, including plasmid and RNA construct design as well as RNA engineering and optimization via trusted partners (UTR, poly(A) and cap optimization). The scientists also conduct lipid library screening and lipid nanoparticle formulation and provide functional assays and analytical services.
By integrating early-stage R&D support with a globally interconnected GMP manufacturing network, CRS helps customers streamline development and reduce supply-chain fragmentation. The approach enables an accelerated path from design to delivery in the field of advanced therapies, while lowering risk and cost through nimble resourcing in early phases and a scalable transfer to Wacker Biotech for high-quality clinical material.
WACKER is now able to support customers through their entire drug development and manufacturing journey, starting with R&D. Source: WACKER
The CRS team is the same expert group behind PLASMITEC®, WACKER’s platform and proprietary E. coli strain for pDNA production. In addition, the team has led more than 100 collaborations with academic and consortia partners. It has extensive experience with RNA modalities that underpin many advanced therapeutics and vaccines under investigation, including mRNA, circular RNA and self-amplifying RNA (saRNA).
“Every RNA or LNP project is unique. Our goal is to provide flexible, customizable services that adapt to our clients’ specific needs in a rapidly evolving landscape. Too often, innovative, potentially life-saving therapeutic concepts die on the vine due to the high cost of developing even small amounts of drug substance for R&D studies. Our Contract Research Services enable us to serve highly specialized customers – especially small start-ups – with competitive pricing and timelines,” said WACKER Global Program Manager CRS Christian Dubiella.
One of the first customers is SRTD Biotech GmbH. Bernd Hoffmann, CEO/CSO and Cofounder of SRTD, said: “As an emerging biotech company, our development of new therapeutic approaches starts at a small scale. Our platform technology based on seRNAs (selectively expressed RNAs) can easily be adapted to numerous therapeutic areas by utilizing the transcriptome for selective cell targeting and fusogenic LNPs for organ-specific targeting. With its vast expertise and resources, WACKER is an ideal partner on the road to realizing our vision of delivering seRNAs to patients to improve their lives. CRS helps us to speed up the path from design to delivery.”
What is currently established for nucleic acid based vaccines and therapeutics within WACKER’s CRS will be successively expanded, with protein based CRS representing the next step.
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WACKER Biotechnology Center Lab
WACKER is now able to support customers through their entire drug development and manufacturing journey, starting with R&D. Source: WACKER
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WACKER Biotechnology Center
WACKER Biotechnology Center moves into new building on Group’s research location in Munich. Photovoltaic panels adorn the facade of the Biotechnology Center.
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