Thermo Fisher Scientific’s Biologics Manufacturing Facility, Lengnau, Switzerland

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The state-of-the-art fully automated facility is built on a 1.5 million square feet site and comprises three buildings, including Building A, B and C. Biomanufacturing facility Lengnau, Switzerland 1.5 million square feet 2022 Thermo Fisher Scientific Thermo Fisher Scientific developed a new biologics manufacturing facility in Lengnau, in the Swiss canton of Bern, to improve its pharmaceutical services capacity and manufacturing capabilities to meet the growing demand for biologic therapies. Thermo Fisher Scientificassumed operational responsibility for the facility in October 2021 under a long-term lease agreement signed with CSL in May 2020. The Lengnau facility manufactures life-saving treatments for patients suffering from rare diseases all around the world. More than 200 biopharmaceutical professionals are working at the facility. Thermo Fisher Scientificis adding three 5,000-litre DynaDrive bioreactor suites to the Lengnau facility. The new bioreactors are expected to be commissioned by the fourth quarter of 2024. The state-of-the-art fully automated facility is built on a 1.5 million square feet site and comprises three buildings, including Building A, B and C. Building A includes process development and analytical services while Building B includes highly flexible bioproduction technologies, including 5,000-litre single-use and 12,000-litre stainless steel bioreactors, and Building C includes 3,000m² of manufacturing space. Services offered by the facility include custom preclinical upstream and downstream process development services, process optimisation and technology transfer for clinical supply phases and commercial production. The facility can produce 120 batches a year and includes multiproduct downstream processing trains in addition to manufacturing science and technology (MSAT) laboratories for technology transfer and optimisation. The stainless steel production suites include separate large-scale media and buffer preparation areas, while the single-use production suites include buffer preparation areas and inline conditioning. MSAT laboratories comprise more than 372m² of space for process development and analytical services in addition to state-of-the-art process monitoring and laboratory-scale investigations and process improvement capabilities. The quality control laboratory capabilities of the facility include more than 277m² of space for monitoring, in-process control, downstream release testing and ion chromatography capabilities. The facility is also equipped with advanced automation features such as an automated manufacturing execution system with electronic batch records and full electronic traceability through scanning and barcoding of materials and equipment used. It also features an automated weigh and dispense system for media/buffer preparation. The facility supports the production of CSL’s product portfolio, including its next-generation haemophilia product Idelvion. Idelvionis a recombinant coagulation factor IX-albumin fusion protein. It is a novel, long-acting recombinant DNA-derived coagulation factor IX concentrate used for treating children and adults with congenital factor IX deficiency (Haemophilia B). The US Food and Drug Administration approved Idelvionin March 2016. Haemophilia B is an inherited bleeding condition caused by a deficiency or abnormality in blood clotting factor IX, primarily affecting males. Patients may experience persistent or spontaneous bleeding, particularly into the muscles, joints, or internal organs. Idelvionextends the half-life of recombinant factor IX by fusing it with recombinant albumin. It allows factor IX to remain in the blood for longer. The drug received marketing authorisation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in February 2016. It is also approved in Canada, Japan and Australia. Thermo Fisher plans to increase its capacities for the development, manufacturing and commercialisation of drug products, biologics, and cell and gene therapies. It also opened a new viral vector manufacturing facilityinPlainville, Massachusetts, US, with an estimated investment of $180m to double its viral vectors manufacturing capacity in August 2022. Thermo Fisher has also invested in the expansion of itspharmaceutical services capabilities for the biotechnology clients working on antiviral therapies, and pharmaceutical developers working on novel coronavirus vaccines.It is offering its global pharmaceutical services network to support approximately 100 Covid-19 client projects. Headquartered in Waltham, Massachusetts, US, Thermo Fisher Scientific is a significant supplier of scientific instruments, reagents, consumables, and software services. It employs more than 90,000 personnel worldwide. The company provides an unmatched combination of breakthrough technologies, purchasing convenience, and pharmaceutical services through its brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon. The Lengnau facility is an important addition to Thermo Fisher’s global biologics production network, which includes its facilities in the US, Australia, the Netherlands, and China. Thermo Fisher alsoplans to expand the utility of the facility by enabling other biopharmaceutical customers to use the site for their projects by offering end-to-end services from development to large-scale production, according to the evolving manufacturing requirements. The products offered by Thermo Fisher Scientific include CEDIA Products, CellInsightHCS instruments, FastDigestenzymes, Dionexchromatography systems, Nunccell culture products, Pierceprotein biology products, Remelmicrobiology products, and Oxoidmicrobiology products. 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