Announced in 2023, contract development and manufacturing organization (CDMO) ten23 has opened its Visp, Switzerland facility comprising commercial and clinical capacity including fill/finish of vials, syringes, and cartridges, along with dedicated quality control (QC) microbiology laboratories and office space.
The expansion is expected to add at least 100 jobs to the region. Financial details of the expansion were not disclosed.
“We already manufacture highly viscous products – up to 650 centipoise (cP) – on our [first line] and have considerable knowledge in that space. The unique capabilities of our [second line] will enable our customers to fill highly viscous formulations at larger scale,” Hanns-Christian Mahler, CEO, ten23 told BioProcess Insider.
“Our [third line] is a bulk vial/lyophilization line with sizable lyophilizers (2 x 12.5 square-meter). It will allow both clinical and commercial manufacture. In addition, our process development labs in Basel (Switzerland) now also include a pilot fill line with lyophilization that allows seamless development from clinical to commercial scalability for freeze-dried or liquid bulk-vial based products."
Both the existing and operational first lines in Visp are filling ready-to-use (RTU) primary packaging such as vials, cartridges, and syringes. The second line is an eight-headed filling machine and serves as a scaled-up version of the first line; both lines are based on class c isolator technology and utilize filling with automated robots and peristaltic and piston pumps.
Unlike standard RTU tray/nest filling machines operated by many manufacturers, the fill lines at this facility use robots. Filling takes place outside the nest and tray, enabling high-precision filling and stopper settings and tight fill precision even for ultra-low fill volumes while avoiding headspace in syringes and cartridges.
“We are in the process of obtaining the GMP certifications for the various components of the facility, i.e. the QC labs and both fill lines, in due course. We operate all sterile fill lines with isolators in class c based on thorough assessment related to annex one compliance,” added Mahler.
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