Lonza Expands Bioconjugation Facility and Announces Approval of Third Commercial ADC
• Expansion to bioconjugation facility in Visp, Switzerland to meet increasing clinical, launch and commercial market demand
• Facility recently approved for the commercial manufacture of third antibody-drug-conjugate (ADC)
• All ADC elements currently available under a single quality system in the Lonza network and from 2020 at a single site
Quote from Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech:
“With 11 INDs completed, and now three out of five commercially available ADCs supported by our bioconjugation facility, we see the need to expand in readiness for the new wave of therapies our customers are developing. Many bioconjugates are on expedited programs and the existing expertise at the facility, combined with proximity to clinical and commercial manufacturing of antibody, linkers and payload, will reduce risk and increase speed on the path to market.”
Quote from Thomas Rohrer, Head of Commercial Development Bioconjugates, Lonza Pharma & Biotech:
“A high proportion of bioconjugates we deal with have accelerated approval and this latest approval was no exception. Meeting the tight deadlines of fast-tracked molecules requires seamless teamwork with the client and close collaboration to deliver the successful validation work required for launch of life-saving medications.”
Basel, Switzerland, 24 July 2019 – Lonza today announced the start of expansion to its bioconjugation facility in Visp, Switzerland together with the successful commercial approval of a third antibody-drug-conjugate (ADC) produced at the site. Building on 12 years of experience in the exacting bioconjugation space, Lonza's expansion will meet the development and manufacturing needs of pharma and biotech companies developing a new generation of therapies.
Lonza's Visp site completed a successful FDA inspection for commercial manufacture of a recently approved ADC, the third to be commercialized from the bioconjugation facility. The existing capacity at the Visp facility will cover the current needs for production of this fast-tracked therapy.
In addition, increasing demand from customers has prompted the Swiss contract development and manufacturing organization (CDMO) to commence an expansion that will span the next two years. The additional capacity, with contracts already in place, will provide current and future customers with launch and commercial manufacturing and will serve the rapidly expanding early clinical phase market for bioconjugates.
Bringing bioconjugates to market remains complex and Lonza is working at all stages of development and manufacturing - from expression systems with site-specific integration (SSI) vectors to a simplified supply chain with the option of all elements (antibody, linker and payload) under the same quality system. From 2020, all elements will be available at a single site through Ibex™Solutions and the newly expanded highly-potent API (HPAPI) facility. Furthermore, the recently announced addition of parenteral fill and finish gives customers the option of cGMP drug product as well as drug substance development and manufacturing.