ten23 health, the human-centric and sustainable strategic CDMO partner for the pharmaceutical industry and biotech start-ups announced updates for its VIVA2 facility in Visp, Switzerland.

As the next step in the expansion project with the VIVA2 facility, the newly installed filling line, “Line 2” is on track to receive its GMP approvals, and two customer programs are already in tech transfer for manufacturing on the line. As announced in December 2025, ten23 health has obtained the Swissmedic GMP license for its QC microbiology facility at VIVA2, including sterility testing, and has also received GMP licenses for storage and sampling at the VIVA2 facility.

With the high-precision aseptic filling Line 2, ten23 can support large-scale manufacturing for a range of syringe and cartridge, as well as vial configurations based on ready-to-use (RTU) formats. Designed with the latest isolator technology, Line 2 will support GMP Annex 1-compliant clinical and commercial manufacturing for human use.

The new Line 2 offers a significant capacity increase of 8-fold over Line 1 at the adjacent VIVA1 site.  Compounding volume at Line 2 can reach up to 500L and batch sizes, depending on format and fill time, will be around 150,000 units (syringes, cartridges or vial) or more per batch. The line is configured for the aseptic fill-finish of dosage forms in ready-to-use (RTU) vials, pre-filled syringes (PFS), and cartridges, both glass and polymer. It can process primary packaging, glass and polymer of different sizes: vials from 2R to 30R; syringes from 0.5ml to 5.5ml and cartridges from 1.5ml to 10ml.

Some options include “more-difficult-to-produce” non-standard formats, that ten23 has vast experience and knowledge of and which are already established on ten23’s other manufacturing lines, such as large-volume SC cartridges and smallest fill volume syringes for intravitreal use. Together with the recently announced device assembly services for on-body-injectors (OBI) like YpsoDose , ten23 health offers a compelling service for cartridge manufacturing and device assembly throughout its different facilities.

The robot-assisted, out-of-the-nest filling eliminates glass-to-glass contact entirely and supports highest precision for filling, allowing both peristaltic and piston pump filling, and stopper setting, using both vacuum and mechanical stopper setting technology, enabling basically headspace-free syringe and cartridge products. Based on prior experience at ten23 with filling up to 600 cps viscosity, Line 2 will similarly be able to handle highly viscous products.

"Line 2 was built around a simple principle: that compliance, innovation, and sustainability should be the same answer, not competing priorities,” said Stephanie Knüppel. Chief Operation Officer at ten23. “We give our customers something genuinely unique: a fill-finish environment where regulatory compliance and manufacturing go hand in hand. And doing that inside a building powered by its own photovoltaic façade is not a coincidence — it is the same logic applied to the planet. That is what we believe our customers deserve, and what Line 2 delivers."

Line 2 is based on “Isolator in C” technology, providing advanced barrier controls for optimal product protection and compliance, compared to traditional RABS system. It also provides Annex 1 compliance, including implementation of PUPSIT based on proven technology at smaller scales with Line 1. Line 2 was “build-to-scale” as it is based on similar technology compared to Line 1 (GMP) and Line 0 (Pilot, development), enabling seamless tech transfers and scale-ups. It uses fully disposable or dedicated fluid paths with proven technology at smaller scale. Process controls include 100% fill weight control (similar to Line 1) and stopper position controls.

“We are pleased to see Line 2 at VIVA2,” adds Hanns-Christian Mahler, CEO of ten23 health. We custom-built Line 2 with a full concept in mind, from our Line 0 to Line 1 and now Line 2. For programs that demand the most: enabling products that require precision and capability, such as products for subcutaneous or intravitreal use, also to be used in combination with devices. For patients whose treatment depends on every unit being produced with high precision, and the pharmaceutical customers who need a partner that can provide expertise, enabling their program from preclinical to clinical trial to commercial stages and providing options and derisking along the way.”