Lonza, a contract development and manufacturing organization (CDMO), began the expansion of its bioconjugation facility in Visp, Switzerland. The site will be completed by 2020 and will hold all elements of antibody-drug conjugate (ADC) production in a single site.
At the same time as the expansion announcement, Lonza confirmed that its Visp site had completed a successful inspection by the US Food and Drug Administration (FDA) for the commercial manufacture of an unnamed ADC.
The product becomes the third ADC manufactured at the site, with commercial manufacture of the ADC met by existing capacity. The two-year expansion project is being carried out to meet anticipated further demand.
Karen Fallen, head of mammalian and microbial development and manufacturing at Lonza, said, “With 11 investigational new drugs (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.”
In addition, the expansion will be able to cover the range of manufacturing, from early clinical phase to commercial manufacture.
Fallen continued, “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.”
In particular, Thomas Rohrer, head of commercial development bioconjugates at Lonza, stated that the third ADC that will be produced as the site had received accelerated approval. This meant that handling its development in one site helped the CDMO meet the ‘tight deadline’ involved for successful validation of the manufacturing process.
Lonza has previously invested in its manufacturing sites at the location to be able to simplify the ADC supply chain, by manufacturing intermediates and drug substances under one system.
