Swiss CDMO Lonza has announced that the expansion of the bioconjugation capabilities at the Visp facility has started. The move coincides with the commercial approval of a third antibody-drug-conjugate (ADC) produced at the site.
Lonza’s expansion builds on 12 years of experience in the precise bioconjugation space, will meet the development and manufacturing needs of pharma and biotech companies developing a new generation of therapies.
The Swiss drug-maker also aid that increasing demand from customers has prompted the company to commence an expansion that will span the next two years.
Lonza’s Visp site passed an FDA inspection for commercial manufacture of a recently approved ADC, the third to be commercialised from the bioconjugation facility. The existing capacity at the Visp facility will cover the current needs for the production of this fast-tracked therapy. Lonza said contracts are already in place.
Karen Fallen, Head of Mammalian and Microbial Development and Manufacturing, Lonza Pharma & Biotech, commented: “Many bioconjugates are on expedited programmes 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.”
Lonza has completed 11 INDs, and now three out of five commercially available ADCs are supported by our bioconjugation Visp facility.
The additional capacity will provide current and future customers with the launch and commercial manufacturing and will serve the rapidly expanding early clinical phase market for bioconjugates.
Site-specific integration
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.
Business update
Lonza has also reported its latest financial review for the first six months of 2019. The company said the positive momentum continues in its core healthcare businesses with 6.4% sales and 7.7% CORE EBITDA growth for the group, resulting in a CORE EBITDA margin of 27.8%.
Half-year performance was driven by Lonza's Pharma Biotech & Nutrition segment achieving 10.8% sales growth and a 33.2% CORE EBITDA margin.
The Specialty Ingredients segment reported a 3.8% decline in sales in H1 2019. However, the CORE EBITDA margin increased by 20bps to 19%, despite headwinds caused by raw material price increases, supply chain challenges and negative cyclical impacts.
All figures relate to Lonza’s continuing operations (excluding the Water Care business unit) in reported currency and are compared with the same period in 2018 on a like-for-like basis.
Lonza Group CEO Marc Funk, said Lonza is on track to deliver on our Full-Year 2019 outlook. "The strong momentum in our contract development and manufacturing organization (CDMO) businesses continues to drive our financial performance. Challenges in other parts of the business are being addressed. We are already working to deliver a recovery in the performance of the Specialty Ingredients segment. Our focus is supported by the carve-out program, which has already provided some improved transparency on cost and profitability."
"Our segment realignment earlier in the year has given Specialty Ingredients greater autonomy to push towards a leadership position in microbial control. Concurrently, Pharma Biotech & Nutrition maintains positive momentum as a major player in Life Sciences. Our targeted, high-return growth projects are progressing as planned and the strength of our current market position is validated by the number of confirmed strategic contracts."
