Basel & Visp, Switzerland, ten23 health, a global contract development and manufacturing organization (CDMO) focused on sterile and biologic drug products, announced it has successfully obtained GMP certifications for the manufacturing and testing of Advanced Therapy Medicinal Product (ATMP) in its facilities in Basel and Visp, Switzerland.

These licenses mark a significant milestone in ten23 health’s strategic expansion into the rapidly growing field of advanced therapies. With this authorization, 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 program 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.

About ten23 health

ten23 health, located in Basel and Visp, Switzerland, and with commercial presence in the USA and offices in Tokyo, Japan, is the human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups: we develop, manufacture, and test modern medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatment options for patients.
ten23 health® combines the latest scientific findings with proven and tested world-class industry and regulatory expertise to forge new paths for supporting clients. We provide our innovative services in a fair and sustainable manner, respecting people’s health and the future of our planet. ten23 health is a B Corp member and solidly financed through the long-term commitment of 3i Group, an internationally reputable equity partner.

About the company’s name

The numeric value for the number of molecules in a sample of one mol is called Avogadro constant and equals 6.022 * 10²³. Gram quantities of material contain the incredible number of 10²³ atoms, which was an important discovery to understand the composition of matter: The world is built from small units, and not a homogeneous mass.

About 3i Group

3i is an investment company with two complementary businesses, Private Equity and Infrastructure, and invests in mid-market companies headquartered in Europe and North America. 3i’s Private Equity team provides investment solutions for growing companies, backing entrepreneurs and management teams of companies with an EV typically between €100m – €500m. 3i backs international growth plans, providing access to its network and expertise to accelerate the growth of companies across the consumer, healthcare, industrial and private label, and services and software industries.

Media contacts:

ten23 health: Mara Willa, mara.willa@ten23.health

3i Group: Kathryn van der Kroft, Kathryn.VanDerKroft@3i.com