Lonza, a pharmaceutical company based in Switzerland, announced the expansion of its bioconjugation facility in Visp, Switzerland in December 2020. The project was completed in February 2023.
The expansion improved the facility’s bioconjugation capabilities by adding development and production capacity for pre-clinical to commercial scale supply and helped in meeting the increased demand for bioconjugates.
The project complemented Lonza’s recent investments at the Visp site to expand manufacturing capabilities in mammalian capacity, microbial development, payload-linker and antibody drug-conjugates (ADCs).
The expansion also helped in increasing the process, analytical development, and quality control capacity of the Visp site to enable Lonza to provide tailored solutions to customers.
Lonza’s bioconjugation facility expansion details
The bioconjugation facility was expanded with the addition of 1,500m² manufacturing space, which added approximately 30% capacity to the facility for clinical and commercial supply.
The extended manufacturing space is equipped with two bioconjugation manufacturing suites with the required infrastructure related to manufacturing. Suites were constructed within a pre-existing shell and benefited from the existing quality control (QC) laboratories, logistics, and other central services, enabling rapid ramp-up, superior performance, and timely delivery.
The highly flexible system utilises single-use, stainless-steel, and hybrid concepts for bioconjugation operations. The high throughput bioconjugation suites are capable of managing highly potent substances for cancer drugs. The two new suites provide high-performance conjugation for the commercialisation of ADCs in Lonza’s Ibex® Dedicate model.
The expansion also involved the addition of a 5,000m² support building, providing logistics, storage, and other related infrastructure space for an optimised workflow. The laboratory space in the facility was also extended, doubling the analytical and process development capacity.
Details of the existing Lonza’s bioconjugation facility
Visp is the largest and one of the most important sites for research and development (R&D) and manufacturing. It houses advanced facilities specialising in the development and production of pharmaceutical products.
The facility’s biconjugation services can support projects from early phase to late stage and commercial programmes, apart from offering drug substance and drug product manufacturing in small molecules and biologics.
Visp also accommodates Lonza’s pioneering services, Ibex™ Solutions. Ibex provides end-to-end biopharmaceutical solutions, including preclinical to commercial processes and drug substance to the drug product, all in one location.
Lonza also opened a manufacturing suite for ADC payload manufacturing at the Visp site in November 2020. The opening of the first manufacturing suite at the Visp site is dedicated to manufacturing ADC drug-linker. It complements the full-service capability for highly active product ingredients (HAPI) from a bench-scale through a 10m³ scale.
The biconjugate and ADC manufacturing services offered at the site include early de-risking and optimisation, process development and optimisation, formulation development, analytical development, drug substance manufacturing, and payload and linker manufacturing.
Other capabilities and services of the manufacturing facility
The Visp site offers customised development, current good manufacturing practice (cGMP) clinical, and commercial manufacturing services for APIs and their intermediates.
The microbial site in Visp houses a range of multi-product cGMP manufacturing and development suites for microbial-derived biotherapeutics production.
Its location also operates as the centre of excellence for developing and manufacturing highly potent API (HPAPI), comprising facilities for small-scale to commercial-scale production and high containment trains.
Lonza’s microbial centre of excellence supports services for several types of molecules, including emerging molecular formats such as antibody fragments, mimetics, and novel scaffolds.
The cGMP site accommodates cell banking, production, fermentation, purification, and quality control. The site also processes development labs and manufacturing assets, including 70 litre (L), 1,000L, and two 15,000L stainless steel reactors, as well as 50L, 200L, and 1,000L single-use reactors.
The facility offers a complete end-to-end solution that simplifies the value chain and accelerates the market for ADCs and bioconjugates manufacturing.
Visp functions within a global quality management system that complies with internal guidelines, and national and international standards and regulations.