ten23 health completes superstructure of large-scale sterile production facility

ten23 health, a global contract development and manufacturing organization (CDMO) announced today the completion of superstructure of their new sterile manufacturing facility. The existing FDA- and Swissmedic-inspected facility of ten23 health’s swissfillon in Visp already offers sterile manufacturing of pre-filled syringes, vials, and cartridges for clinical trial and commercial supplies, in close collaboration with ten23 health’s development center in Basel.

ten23 health is now expanding into an additional building in Visp with approximately 5,000 square meters of space. The initial phase of construction is complete. The expansion will comprise of two additional sterile manufacturing lines using the latest isolator technology, providing optimal sterility assurance levels. One new filling line will provide significant additional capacity for ready-to-use containers such as syringes and cartridges with an annual capacity of 20 million units, enabling scale-up from ten23’s existing production line in Visp. A third new manufacturing line with its two lyophilizers will provide new capabilities for filling bulk containers (vials) in liquid and freeze-dried (lyophilized) dosage forms with an estimated 10+ million units.

The expansions reflect the commitment of ten23 health to their activities in Visp, Valais, Switzerland and the increasing market demand in providing customized expert solutions for their customers and patients globally. The new building’s facade will consist of 100% of photovoltaic panels, ensuring to generate energy at the facility, in line with their commitments towards the planet and use of 100% renewable energy.

The new building, purpose-built for ten23 health, includes two further sterile manufacturing lines. Line 2 will produce large commercial quantities for market supply after regulatory approval of the drug. As a true scaled-up version of their existing filling line 1, the transfer between the lines will be associated with less risk for their biopharma customers. The fill line will be based on latest Isolator technology to increase the safety of the drugs for patients. It will focus on complex products, filled into RTU containers including syringes, cartridges and special primary packaging such as used in specific administration devices for subcutaneous delivery. Fill line 3 will broaden ten23 health’s offering to also process bulk containers (vials), both in liquid and lyophilized form, with two large-scale freeze-driers, each at 12.5 square meters of shelf-space for clinical and commercial use.

ten23 health continues to hire additional colleagues to support the new production lines.

A unique feature of the new facility is photovoltaic facade, covering the complete building exteriors, and being able to provide 45’000 kW per year. ten23 health’s facilities in Basel and Visp already operate with 100% renewable energy, consistent with their commitment for the planet.

Prof. Dr. Hanns-Christian Mahler, CEO of ten23 health, commented: “The completion of the initial phase of construction is a major milestone for ten23 health, their customers and patients, and towards providing a significant amount of capacity for commercial and clinical sterile medicines for patients. In addition to securing renewable energy for the facility, we are investing in photovoltaics across the whole facade. We are excited to continue building ten23 health into a leading sustainable contract development and manufacturing worldwide.”