Bioconjugation facility expansion
Lonza announced the expansion of its bioconjugation facility at its Visp site in Switzerland in December 2020.
The expansion will improve the facility’s bioconjugation capabilities with the addition of development and production capacity for pre-clinical to commercial scale supply.
The manufacturing facility expansion will enable the company to provide highly flexible solutions to a wide range of clients and will complement Lonza’s recent expansion of customer-dedicated suites, which is a part of Ibex® Dedicate model. Ibex® Dedicate is a technology-agnostic supply approach that helps minimise time to market and monitor investment risk.
Clients will benefit from the company’s experience and in-house supply of integrated offering encompassing protein, linker, payload and conjugation, thus reducing supply chain risks and accelerating the path to commercialisation.
The long-term partnership of Lonza with a multinational biopharmaceutical company will create approximately 200 new jobs in the Visp biopark. The new facility is scheduled to commence operations in the first half of 2022.
The bioconjugation facility will be expanded with the addition of 1500m2 manufacturing space, which will add approximately 30% capacity to the facility for clinical and commercial supply.
Extended manufacturing space will be equipped with two bioconjugation manufacturing suites with the required infrastructure related to manufacturing. Suites will be constructed within a pre-existing shell and will be benefited by the existing quality control (QC) laboratories, logistics and other central services, enabling rapid ramp-up, superior performance and timely delivery.
The highly flexible system will utilise single-use, stainless-steel and hybrid concepts for bioconjugation operations.
High throughput bioconjugation suites will be capable of managing highly-potent substances for cancer drugs and will initially produce two therapies for cancer treatment.
The two new suites will provide high-performance conjugation for the commercialisation of antibody-drug conjugates (ADCs) in Lonza’s Ibex® Dedicate model.
The expansion will also involve the addition of a 5000m2 support building, which will provide space for logistics, storage and other related infrastructure for an optimised workflow. The laboratory space in the facility will also be extended, doubling the analytical and process development capacity.
Additionally, the opening of the first manufacturing suite for antibody-drug conjugate (ADC) payload manufacturing at Visp (CH) site in November 2020 and acquisition of Novartis’ sterile fill-finish facility will support the rising development and manufacturing requirements for bioconjugates.
Visp is the largest and one of the most important sites for research and development (R&D) and manufacturing. It houses advanced facilities specialised in the development and production of pharmaceutical products including mammalian and microbial biopharmaceuticals, small molecules, highly potent active pharmaceutical ingredients (APIs), peptides and bioconjugates including ADCs.
Visp also accommodates the 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.
The recently opened first manufacturing suite at the Visp (CH) site is dedicated to the manufacturing of ADC drug-linker and complements the full-service capability for highly active product ingredients (HAPI) from a bench-scale through a 10m3 scale.
The Visp site offers customised development, cGMP clinical and commercial manufacturing services for APIs and their intermediates.
The Microbial site in Visp (CH) 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 the development and manufacturing of 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 and process development labs and manufacturing assets, including 70l, 1,000l and two 15,000l stainless steel reactors, as well as 50l, 200l and 1000l single-use reactors.
Visp functions within a global quality management system that complies with internal guidelines, as well as national and international standards and regulations.
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