By leveraging the company’s experience in biopharmaceuticals and small molecule drug process development and scale-up, Lonza has been successful in manufacturing antibody-drug conjugates, a class of high potency biologicals.

Photo 1.0: Lonza’s exhibition booth during the 2016 CPhI World Wide in Barcelona, Spain. Courtesy: © 2017 Sunvalley Communication, LLC. Used with permission. 

While there are many unique challenges in the manufacturing of highly potent biopharmaceuticals Lonza has designed and build a large-scale manufacturing plant dedicated solely to the manufacturing of ADCs.

As pioneers in developing innovative manufacturing pathways for active pharmaceutical ingredients or APIs, Lonza’s ADC experts offer superior services in the production of many next gen antibody-drug conjugates.

A decade of manufacturing
This year Lonza celebrates a decade of antibody-drug conjugate (ADC) manufacturing under cGMP.  The company currently manufactures more than 50 ADC batches per year with 98% batch success rate. On top of two commercial ADC projects, Lonza supports 20 clinical and several pre-clinical projects.

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“Through 10 years of milestones in ADC, Lonza has had the privilege of working with both small and large biopharmaceutical clients to deliver innovative, lifesaving targeted therapies in the form of antibody drug conjugates to oncology patients worldwide,” said Dr. Thomas Rohrer, Associate Director Commercial Development Bioconjugates at Lonza.

With improvements in diagnostic tools and the transition to a personalized approach to treatment, ADCs – combined with other small- and large-molecule drugs – hold the promise of higher patient-response rates for many difficult-to-treat cancers.

Photo 2.0: Manufacturing of ADC at Lonza – Since 2007. Taking its name from the nearby river, Lonza was founded in 1897 in the Swiss town of Gampel in the canton of Valais. Initially the companyused hydroelectric power to produce electrochemical and metallurgical products. Lonza produced calcium carbide (CaC2, also known as carbide) in an electric arc furnace from a mixture of lime and coke at approximately 2,000°C. The reaction of carbide with water gives acetylene which was used in carbide lamps. Following a move to Visp, the company started to transform itself from an electricity-generating company to a chemical company and ultimately to one of the world’s leading suppliers to the pharmaceutical, healthcare and life science industries. Today, the plant in Visp is Lonza’s largest site and one of the most significant for production and R&D. It is also the location where Lonza, in 2007,  has established its antibody-drug conjugate (ADC) manufacturing capacity. In 2013, Lonza invested CHF 14 million to expand its ADC capacity. Courtesy: © 2017 Lonza. Used with permission.

Next-gen ADCs
“As the next generation of highly potent ADCs evolves, we will work diligently to provide our clients with innovative technical solutions, reliable manufacturing and sustaining value for all their drug substance and product needs,” noted Rohrer.

Over the last 10 years, Lonza has worked with novel linkers, conjugation methods and toxins. Lonza has also adapted and deployed single-use technologies to streamline product change-over in Lonza’s cGMP assets.

“This improvement results in extra capacity being made available to our customers,” said Laurent Ducry, PhD, Commercial Development Head for Bioconjugates at Lonza.

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