FOR IMMEDIATE RELEASE
July 24, 2019
Contact:
Dr. Sanna Fowler
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929
sanna.fowler@lonza.com
Lonza Expands Bioconjugation Facility and Announces Approval of Third Commercial ADC
Basel, Switzerland – 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.
• 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.”
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.
About Lonza
Lonza is an integrated solutions provider that creates value along the Healthcare Continuum®. Through our Pharma Biotech & Nutrition segment and our Specialty Ingredients segment businesses, we harness science and technology to serve markets along this continuum. We focus on creating a healthy environment, promoting a healthier lifestyle and preventing illness through consumers’ preventive healthcare, as well as improving patient healthcare by supporting our customers to deliver innovative medicines that help treat or even cure severe diseases.
Patients and consumers benefit from our ability to transfer our pharma know-how to the healthcare, hygiene and fast-moving consumer goods environment and to the preservation and protection of the world where we live.
Founded in 1897 in the Swiss Alps, Lonza today is a well-respected global company with more than 100 sites and offices and approximately 15,500 full-time employees worldwide at the end of 2018. The company generated sales of CHF 5.5 billion in 2018 with a CORE EBITDA of CHF 1.5 billion. Further information can be found at www.lonza.com.
Lonza Contact Details
Dr. Kristin Koehler
Investor Relations
Lonza Group Ltd
Tel +41 61 316 8782
kristin.koehler@lonza.com
Dr. Sanna Fowler
Head of External Communications
Lonza Group Ltd
Tel +41 61 316 8929
sanna.fowler@lonza.com
Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
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