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SGS’s new Antwerp, Belgium, clinical research site will house both clinical trial patients and good manufacturing practice drug manufacturing, and its Glasgow, UK, biosafety testing site now has increased testing capacity.
SGS announced the official opening of its new clinical pharmacology research center in Antwerp, Belgium, on Oct. 26, 2021, and the completion of an expansion at its biosafety testing site in Glasgow, UK, on Oct. 28, 2021.
The newly built SGS Clinical Pharmacology Unit (CPU) in Antwerp is aimed at early phase research. The facility’s strategic location next to the University Hospital of Antwerp (UZA) reinforces scientific collaboration between SGS and a network of specialists and techniques. The CPU is a sustainable facility with a capacity of 110 beds. Study participants can stay in two-to-eight person rooms or in individual rooms and have access to comfortable living and leisure areas. Follow up during first-in-human testing of new drugs will be conducted in a high-care room. In addition, two specialized quarantine units are available for controlled investigation of infection models or controlled human infection models (CHIM). The SGS CPU conducted the first malaria challenge studies in Belgium with its own developed H3N2 (flu) virus.
The CPU also contains a good manufacturing practice (GMP) production unit with level D, C, and B clean rooms for sterile-study drug preparations. It also houses a centrally located laboratory for complex sample processing and use of the latest bed-side monitoring (telemetry). The safety and mechanisms of action of the potential drug under study are mapped.
"Our proximity to Antwerp University Hospital means that expertise is never far away. By joining forces, we are strengthening and broadening our capabilities for early phase clinical research. This new and innovative facility positions SGS at the forefront of clinical research and helps us contribute to a healthier and safer society over the coming years," said John Pype, SGS Benelux managing director, in a company press release.
"Challenge studies will continue to play a key role in the development of drug and infectious disease vaccines in the future. These studies can be a crucial time-saving step in the clinical development of antiviral drugs, for example, by showing efficiency and safety in a controlled environment quickly and safely. That is why we have also decided to focus on expanding our quarantine capacity. This will enable us to conduct studies with a wide range of study participants more efficiently and quickly," said Annick van Riel, director Clinical Pharmacology Unit, SGS, in the press release.
Meanwhile, the expansion at SGS’ Glasgow biosafety testing site is aimed at helping to accelerate quality testing and reduce turnaround time. The expansion project, which began in March 2021 and was completed in September 2021, adds 550 m2 of space and 16 biosafety level 2 (BSL-2) laboratories to the facility.
New equipment installed at the site include BSL-2 cabinets, enzyme-linked immunosorbent assay technology, cell culture equipment for virus detection, and real-time polymerase chain reaction testing equipment. The Glasgow expansion completes previous rounds of investment in 2020 and 2019, which increased capacity for cell bank testing and routine bulk harvest for vaccines, gene and cell therapies, monoclonal antibodies, and other recombinant protein-based biological medicines.
"Most notably, the Biosafety Center of Excellence in Glasgow has participated in the batch-testing and release of over [one] billion doses of COVID-19 vaccine, helping to increase vaccine access and bring the global population out of the pandemic," said Archie Lovatt, site manager & scientific director, SGS, in a company press release.