ten23 health announced today that it obtained GMP certifications for pharmaceutical manufacturing in a duo of Swiss facilities.
The company secured licenses to manufacture and test advanced therapy medicinal product (ATMP) in its Basel and Visp, Switzerland, plants. It said this marks a significant milestone in the planned strategic expansion for the global contract development and manufacturing organization (CDMO) focused on sterile and biologic drug products.
With both sites GMP-certified, ten23 can now support the clinical and commercial sterile manufacturing of ATMPs. The company already has its first oligonucleotide customer program is in progress, advancing further into clinical development. It can also support its customers for GMP sterile manufacturing and QC testing and clinical and commercial use for oligonucleotide products such as mRNA, siRNA, DNA and antisense oligonucleotides.
ten23’s Basel facility supports early- and late-phase product development, small-scale non-GMP manufacturing and GMP quality control release and stability testing. In Visp, the facility provides 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.”
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