Recipharm has designated its Cuxhaven, Germany facility as a Centre of Excellence for analytical services supporting advanced therapy medicinal products (ATMPs) and biologics. The site now operates 500 m² of CGMP-compliant laboratories designed to handle projects from early-stage development through commercial manufacturing.
The Cuxhaven laboratories are equipped for a range of quality control testing methodologies, including microbiological and viral assays, nucleic acid quantification, and complex techniques such as droplet digital PCR (ddPCR), quantitative PCR (qPCR), and Western blotting. The team has more than 15 years of experience in analytical method development and qualification, offering both compendial and custom assays.
By consolidating analytical workflows at the site, Recipharm aims to reduce dependency on external service providers, shorten testing timelines, and enable streamlined method onboarding. The facility includes in-house QC and stability chambers covering all ICH conditions, sterility testing capabilities, and scalable capacity for diverse therapeutic modalities.
The 9,300 m² Cuxhaven site operates at BSL-2 containment and supports production and analytics for viral vector therapies, recombinant proteins, monoclonal antibodies, and sterile fill and finish operations, providing integrated support from preclinical studies to commercial readiness.