Italian Biotech ReiThera selected SGS to utilise its team of virology and molecular biology experts to conduct microbiological biosafety and identity release testing at each key stage of the vaccine candidate's production. All testing will be undertaken from its Biosafety Center of Excellence in Glasgow which recently benefited from a major expansion. The Center is fully equipped to test to speed and scale, with increased capacity for testing cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other protein based biological medicines.
The SGS team will employ a range of Good Manufacturing Practice (GMP) investigations from molecular biology, classical virology, transmission electron and other methodologies to ensure tests conform to national and international regulations.
One of the key methodologies used is nucleic acid technologies to detect specific viruses & other pathogens, at a sensitive limit of detection in compliance with Health Regulatory Guidelines. These assays allow fast-track release testing of GMP batches for the rapid and continuous supply of key vaccines like COVID-19.
Dr. Archie Lovatt, Scientific Operations Director (Biosafety), SGS Biosafety Center of Excellence said: "As pioneers in the development of the biosafety testing industry, we are proud to be part of this consortium at the frontline of global efforts to secure a COVID-19 vaccine. Our experts have more than 25 years' experience of pharmaceutical testing to the highest national and international standards, which is vital to enabling ground-breaking new products to reach global markets quickly and safely."
ReiThera developed the vaccine candidate, based on a simian adenoviral vector, which has shown strong immunological potency and low pre-existing immunity in humans. These vaccines have been extensively evaluated in Phase 1 and 2 clinical trials and proved to be safe and immunogenic.
SGS's Life Sciences operation leverages its digitalised network of laboratories, present in North America, Europe, and Asia-Pacific, to deliver harmonised testing solutions for analytical development, biologics characterization, biosafety and quality control, as well as clinical trial management to large pharmaceutical and biotechnology firms.