ten23 health, a Swiss contract development and manufacturing organisation, today announced that its VIVA2 aseptic large-scale pre-filled syringe (PFS), vial and cartridge Filling Line 2 will be GMP operational by the end of 2024.
Located in Visp, Switzerland, a hub for innovation in the pharmaceutical sector, VIVA2 will provide updated facilities for aseptic manufacturing of commercial and clinical pharmaceutical sterile products.
First announced in June 2022, the project has met its key milestones: the VIVA2 superstructure and building has been completed, ten23 teams moved into the new VIVA2 offices in December 2023, and both the QC microbiology labs and the new filling line are on track to be GMP operational by the end of 2024.
VIVA2 encompasses an 8-headed and Annex 1 compliant Isolator-in-class C based filling line, adding over 30 million units’ capacity of sterile pre filled syringes, cartridges, or vials.
The new line will be able to fill glass and polymer containers of syringes, cartridges and vials, including 0.5 mL, 1 mL, 2.25 mL syringe formats as well as cartridges from 1.5, to 3, 3.5 and 10 mL sizes.
The latter includes cartridges compatible for use in on-body-injector devices (OBIs), e.g. West´s “SmartDose” or other large-volume SC devices.
It also provides specific features that will ensure highest fill precision, absence of headspace and tight process controls as well as Annex 1 GMP compliance, including PUPSIT (pre- and post-use filter integrity testing), 100% weight control, robot-assisted out-of-the-nest filling, both peristaltic and piston filling pumps and various stopper setting techniques.
The ribbon-cutting ceremony for the new building is scheduled for 23rd of September 2024 in Visp, Valais, Switzerland, featuring speeches from ten23 executives, and the opportunity for networking with industry professionals.
This milestone event marks a significant step for ten23 health, as the company continues to increase capacity and adding further capabilities to meet the growing demands of pharmaceutical and biotech industry. A third filling line, specialising in bulk vial filling and lyophilisation, is planned to be GMP operational by the end of 2025.
“We are thrilled to announce the Grand Opening of our VIVA2 facility and that our Line 2 will be GMP operational at the end 2024,” said Prof. Dr. Hanns-Christian Mahler, Chief Enablement Officer of ten23 health. “This investment underscores our commitment to providing Swiss quality services to our customers and advancing innovation in the pharmaceutical industry.”