The expansion adds two production suites to the existing conjugation facility providing development and manufacturing infrastructure for clinical and commercial supply. In addition, the contract development and manufacturing organization (CDMO) said an extension to laboratory space will double the analytical and process development capacity, meaning it can offer its expertise to a broad customer base.
These new manufacturing and lab capabilities are expected to come online from the first half of 2022, said Lonza.
The manufacturing extension spans approximately 1500 m2 and adds 30% more capacity for clinical and commercial supply. Another support building of 5000m2 will provide space for logistics, storage and other supporting infrastructure to ensure an optimal workflow.
The CDMO said this “highly flexible setup” will enable bioconjugation processes using single-use, stainless steel and hybrid concepts.
The bioconjugation capacity boost is said to complement Lonza’s recent expansion of customer-specific suites. Expansions in payload manufacturing capacity and drug product sterile fill and finish will support the increasing development and manufacturing needs for bioconjugates, added the organization.
Lonza flagged that it first began offering CDMO services for antibody-drug conjugates (ADCs) back in 2006, and that, over the past 14 years, it has produced around 600 cGMP batches of bioconjugated products for over 60 different projects.
Weighing in on that, Iwan Bertholjotti, director commercial development, bioconjugates at Lonza, said: "We now manufacture the majority of the currently commercially approved ADCs. The field goes beyond ADC’s and Lonza has the expertise to support customers bringing a range of different bioconjugates to market. The latest investment in additional bioconjugation development and manufacturing capacity is well aligned with other current investments in monoclonal antibodies and small molecules within the Lonza network. Together they further extend our offer of a reliable and integrated supply solution for an expanding class of innovative therapies.”
