ten23 health has obtained Good Manufacturing Practice (GMP) licences from Swissmedic for the manufacture and testing of Advanced Therapy Medicinal Products (ATMPs) at its Basel and Visp facilities, expanding its capabilities to support clinical and commercial production.

The approvals enable the contract development and manufacturing organisation to provide GMP-compliant sterile manufacturing and quality control testing for advanced therapy products, including oligonucleotide-based medicines.

Swissmedic has granted the licences for both the Basel and Visp sites, allowing ten23 health to manufacture sterile ATMP drug products for clinical and commercial use while meeting regulatory quality standards.

The company said the approvals strengthen its ability to support developers of advanced therapies, including products based on mRNA, siRNA, DNA and antisense oligonucleotides.

According to ten23 health, a customer programme involving an oligonucleotide therapy is already progressing through clinical development.

The Basel facility will focus on formulation development, early- and late-stage product development, small-scale non-GMP manufacturing, GMP quality control release testing and stability studies. The Visp site will provide late-stage clinical and commercial sterile manufacturing together with quality control microbiology services.

Hanns-Christian Mahler, chief executive officer of ten23 health, said: “Obtaining ATMP licenses for both Basel and Visp reinforces our commitment to enabling sterile medicines for next-generation therapeutics.”

He added: “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.”

Demand for advanced therapy manufacturing continues to increase as developers advance cell and gene therapies, RNA medicines and other complex biologics through clinical development. GMP-certified manufacturing capacity remains a key requirement for companies progressing products towards regulatory approval and commercialisation.

With the new licences in place, ten23 health is now authorised to support sterile manufacturing and analytical testing for a broader range of ATMPs and oligonucleotide therapies from clinical development through commercial production.