Lonza Expanding Microbial Facility at Visp
Swiss CDMO Lonza is expanding its microbial manufacturing facility in Visp, Switzerland, to add mid-scale (3,000 l) commercial manufacturing for multiple customers and in particular to supply a long-term partner, France’s Laboratoires Servier, with active pharmaceutical ingredients (APIs) for acute lymphoblastic leukemia (ALL) therapies.
Servier and Lonza recently signed a long-term extension to their manufacturing agreement for L-asparaginase, produced at Lonza’s Alpine location since 2009. Servier intends to expand access to asparaginase-based multi-agent chemotherapeutic regimens, as ALL continues to be the most common type of cancer among children diagnosed with leukemia.
The new facility, due to go on stream in 2022 with 100 new employees, will be one of six operating in Lonza’s new biopark currently under construction at Visp. It will tap into the company’s existing central utilities and labs and complement the site’s existing small-scale (1,000 l) and large-scale (15,000 l) assets.
Traditionally used for producing hormones, enzymes and some vaccines, microbial fermentation is becoming increasingly attractive for new molecular formats that do not need human glycosylation, given the higher yields and shorter production timelines, Lonza said. Many antibody fragments, as well as plasmid DNA, can be produced this way.
Jean-Christoph Hyvert, chief commercial office at Lonza, said the company sees “a clear role for microbial technology as new medicines evolve and we are investing in key enablers including expression technology and manufacturing assets.”
The Basel-based company said it is continuously developing the required knowhow, including XS Technologies – an extensive microbial expression toolbox with more than 3,000 individual microbial strains expressed –together with a range of manufacturing assets designed to support customers from clinical supply to commercial production.
Lonza to produce Kodiak’s Wet AMD candidate
Also at Visp, Lonza plans to produce the KSI-301 anti-VEGF biopolymer conjugate being developed by Kodiak Sciences for various ophthalmic retinal diseases. The candidate is in Phase 2/3 studies for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
The CDMO will provide a facility dedicated to the bioconjugation of the potential therapy, using its Ibex Dedicate offering, a series of prebuilt shells at the Visp biopark.
Visp will also serve as a production site for the biopolymer element of the candidate, along with Lonza’s site in Nansha, China. Its facility in Portsmouth, New Hampshire, USA will produce the antibody.
