Lonza is expanding its bioconjugation capabilities at its Visp in Switzerland. The expansion adds two production suites to the existing conjugation facility providing development and manufacturing infrastructure for clinical and commercial supply.
In addition, an extension to laboratory space will double the analytical and process development capacity.
The new capacity is expected to be fully operational for customers from the first half of 2022.
The manufacturing extension spans approximately 1,500 m2 and adds 30% additional capacity for clinical and commercial supply. An additional support building of 5,000 m2 is designed to provide space for logistics, storage, and other supporting infrastructure to ensure an optimal workflow. This highly flexible setup will enable bioconjugation processes using single-use, stainless steel, and hybrid concepts.
The bioconjugation capacity expansion complements Lonza’s recent expansion of customer-specific suites as part of the Ibex® Dedicate model. In addition, expansions in payload manufacturing capacity and drug product sterile fill and finish will support the increasing development and manufacturing needs for bioconjugates.
The continued investments into the Visp, Switzerland, site provide a flexible solution for small, mid, and large biopharmaceutical companies interested in scaling their bioconjugates and bringing them to market quickly and with reduced supply chain risks.
Lonza’s continued expansion in bioconjugation services also includes the acquisition of a sterile fill and finish facility from Novartis in Stein, Switzerland, about 30 kilometers up the Rhine from Basel, a strategically important site for the manufacturing and launch of innovative medicines.
Stein, about 30 kilometers up the Rhine from Basel, is a strategically important site for the manufacturing and launch of innovative medicines. Two pharmaceutical manufacturing facilities for solid and sterile dosage forms are located here. Each year, more than 2 billion tablets, capsules, ampoules, prefilled syringes, vials, and autoinjectors are manufactured, inspected, packaged, and shipped from the Stein site to more than 150 different countriesThe sterile, multi-product facility in Stein was served as the Novartis Center of Excellence for sterile clinical (phases 1 to 3) drug product manufacture. The facility has an excellent quality and safety track record and is cGMP approved. Following closing, Lonza will produce drug products at the facility for Novartis as well as providing capacity for additional customers.
Operational since 2009 the Stein facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities, and storage.
The facility will continue to perform sterile manufacturing including liquid and lyophilized dosage forms for up to 200L bulk volumes for clinical supply and commercial launch. Lonza will continue to employ the highly experienced team at the facility.
Since 2006, Lonza has produced over 600 cGMP batches of bioconjugated products for over 60 different projects.
The company’s experience in navigating the complex supply chain, developing commercial-scale conjugation and purification processes allows customers to streamline regulatory approvals and meet the growing market demands.
