- Recipharm has designated its Cuxhaven facility as the Centre of Excellence for Analytical Services, supporting advanced modalities including biologics and ATMPs.
- The 500 m² state-of-the-art GMP laboratory enhances in-house analytical testing, reducing reliance on third-party labs and supporting projects from early development to commercial manufacturing.
Recipharm, a global CDMO, has announced the designation of its Cuxhaven facility in Germany as the Centre of Excellence for Analytical Services tailored to advanced modalities. The site features newly renovated 500 m² GMP analytical laboratories designed to support both US and EU customers across the full product lifecycle, from early development to commercial manufacturing.
The Cuxhaven team has more than 15 years of experience in analytical method development and qualification. Capabilities include drug substance and drug product QC testing, microbiological and viral assay validation, nucleic acid quantification, and complex techniques such as ddPCR, qPCR, and Western blot. These services are particularly relevant for advanced therapy medicinal products (ATMPs) and biologics.
“By adding key analytical services in Cuxhaven, we are reducing our reliance on external third-party labs, and providing our customers with faster, more cost-effective access to the highest quality analytical testing. Our expanded capabilities position us to better support the growing demands of advanced modality development and manufacturing.”
Vikas Gupta, President of Recipharm Advanced Bio
The facility is designed for operational agility, concentrating test samples in a single location to streamline workflows, accelerate timelines, and ensure seamless onboarding of methods. Key features include in-house QC and stability chambers covering all ICH conditions, sterility testing, and both standard and customisable assays across multiple modalities.
Recipharm Advanced Bio provides end-to-end capabilities across advanced therapies, including plasmid DNA, xRNA, lipid nanoparticles, viral vectors, and sterile fill and finish. The Cuxhaven site, spanning 9,300 m² and BSL-2 certified, supports multi-product programmes including viral and bacterial cell banks, recombinant proteins, monoclonal antibodies, and oncolytic viruses, offering a flexible and integrated pathway from preclinical development to commercial readiness.
