ten23 health has obtained Swissmedic GMP authorisations for the manufacturing and testing of Advanced Therapy Medicinal Products at its facilities in Basel and Visp.

The authorisations allow both sites to manufacture and test sterile ATMPs for clinical and commercial use under GMP conditions. A first customer programme involving an oligonucleotide product is already progressing further into clinical development.

Complementary activities in Basel and Visp

The Basel facility supports early and late-stage product development. Its activities include formulation development, small-scale non-GMP manufacturing through ten23 health’s Line 0, GMP quality control release, and stability testing.

The Visp facilities focus on late-stage clinical and commercial sterile production. They also provide quality control microbiology services.

Together, the two locations allow ten23 health to cover successive stages of a product programme, from formulation and development to sterile manufacturing and quality control testing.

Manufacturing and testing of oligonucleotide products

The GMP authorisations enable ten23 health to provide sterile manufacturing and quality control testing for oligonucleotide products intended for clinical and commercial human use.

The scope announced by the company includes:

• mRNA
• siRNA
• DNA
• antisense oligonucleotides

These activities complement ten23 health’s existing expertise in formulation development for injectable drug products.

Clinical and commercial production in Visp

With the new authorisation, the Visp facilities can support the sterile production of ATMPs for late-stage clinical programmes and commercial supply.

The site’s role is distinct from the development activities conducted in Basel. Product development, small-scale manufacturing and analytical work can begin in Basel before progressing to larger-scale sterile production and microbiological quality control in Visp.

This operating model gives ten23 health a defined pathway for supporting advanced therapy programmes across development, testing and manufacturing within its two Swiss facilities.