Newswire

ten23 health Secures ATMP Manufacturing GMP Licenses from Swissmedic for Basel and Visp Facilities

Basel & Visp, Switzerland, ten23 health, a global contract development and manufacturing organization (CDMO) specializing in sterile and biologic drug products, has announced the successful acquisition of GMP certifications for the manufacturing and testing of Advanced Therapy Medicinal Products (ATMP) at its facilities in Basel and Visp, Switzerland.

This achievement represents a pivotal advancement in ten23 health’s strategic growth within the burgeoning sector of advanced therapies. With the newly acquired licenses, both facilities are now authorized for GMP-compliant sterile manufacturing of ATMPs, facilitating clinical and commercial production. A notable oligonucleotide customer program is currently underway, enhancing its clinical development capabilities. The GMP license enables ten23 to extend its offerings to include GMP sterile manufacturing and quality control testing for a range of oligonucleotide products, such as mRNA, siRNA, DNA, and antisense oligonucleotides.

The Basel facility is recognized for its innovation-driven environment, supporting both early- and late-phase product development alongside small-scale non-GMP manufacturing and GMP Quality Control testing. Conversely, the Visp site leverages advanced infrastructure to provide late-stage clinical and commercial sterile production, along with QC Microbiology services.

“Obtaining ATMP licenses for both Basel and Visp reinforces our commitment to enabling sterile medicines for next-generation therapeutics,” stated Hanns-Christian Mahler, CEO of ten23 health. “We are proud to offer our partners integrated, high-quality sterile product solutions that expedite their molecules’ journey from drug substance to drug products, from concept to patient.”

As the global demand for advanced therapies continues to escalate, ten23 health is strategically positioned to serve as a reliable partner for biotech and pharmaceutical companies seeking flexible and innovative manufacturing solutions.

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