Lonza, the Swiss Contract Development and Manufacturing Organization (CDMO), has confirmed 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.
Manufacturing of ADCs under cGMP presents unique challenges. One of the challenges is that facilities must be designed to handle both biological species and highly potent cytotoxic small molecule drugs.
Lonza has been a pioneer in the manufacturing of ADCs since its initial investment in 2006, which established manufacturing suites for both small and large scale projects. Since 2010, Lonza has validated large scale manufacturing of platform technologies primarily utilized by ADC drug developers.
Building on this experience, Lonza’s current expansion will meet the development and manufacturing needs of pharma and biotech companies developing a new generation of therapies.
“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,” Noted Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech.
All Antibody-drug Conjugates elements are currently available under a single quality system in the Lonza network and from 2020 at a single cGMP manufacturing site
Lonza’s Visp site completed a successful inspection by the U.S. Food and Drug Administration (FDA) for commercial manufacture of a recently approved ADC. This will be the third ADC 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.
“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,” said Thomas Rohrer, Head of Commercial Development Bioconjugates, Lonza Pharma & Biotech.
In addition, increasing demand from customers has prompted the company 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. This includes 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. In addition, the recently announced purchase of a sterile drug product fill & finish facility from Novartis in Stein (CH) enables Lonza to build on existing parenteral drug product development and testing capabilities.
This facility, which currently serves as the Novartis Center of Excellence for sterile clinical (phases I to III) drug product manufacture, has an excellent quality and safety track record and is cGMP approved. After the completion of the transfer, Lonza will produce drug product at the facility for Novartis as well as provide capacity for additional customers, offering them an end-to-end service for clinical supply and launch.