These licenses mark a significant milestone in ten23 health’s strategic expansion into the rapidly growing field of advanced therapies.
With this authorisation, both sites are now GMP-certified to support the clinical and commercial sterile manufacturing of ATMPs in compliance with related quality standards.
A first oligonucleotide customer programme is in progress, advancing further into clinical development.
In addition to ten23’s expertise in formulation development, the new GMP license means that ten23 can now also support its customers for GMP sterile manufacturing and QC testing for clinical and commercial human use for oligonucleotide products such as mRNA, siRNA, DNA and antisense oligonucleotides.
The Basel facility, known for its innovation-driven development environment, provides support for early- and late-phase product development, small-scale non-GMP manufacturing with ten23’s previously announced Line 0 and GMP quality control release and stability testing.
The Visp facilities, leveraging its state-of-the-art infrastructure and scalability, provide late-stage clinical and commercial sterile production and QC microbiology.
“Obtaining ATMP licenses for both Basel and Visp reinforces our commitment to enabling sterile medicines for next-generation therapeutics,” said Hanns-Christian Mahler, CEO at ten23 health.
“We are proud to provide our partners with integrated, high-quality sterile product solutions that accelerate their molecule’s journey from drug substance to drug products, from concept to patient.”
As demand for advanced therapies continues to grow globally, ten23 health is positioned to be a trusted partner for biotech and pharmaceutical companies seeking flexible, reliable and innovative manufacturing solutions.
