In 2019, the SGS Center of Excellence for Biosafety expanded its laboratory facilities to increase its capability and capacity for testing cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines, including a vaccine testing solution for coronavirus.
Archie Lovatt, Scientific Operations Director (Biosafety) at SGS, said: “The new expansion increased the capacity of all existing biosafety services and enhanced real-time polymerase chain reaction (PCR) platforms, to support viral safety and genetic stability assessment of cell banks for vaccines, gene and cell therapies”. He added: “Clients benefit from a fully comprehensive range of validated biosafety methods to support cell bank and viral vaccine manufacturing and lot release of drug product, as well as new technologies for pathogen detection, including next-generation nucleic acid sequencing and new cell based viral detection systems.”
As trailblazers in the development of the biosafety testing industry, the SGS Vitrology team in Glasgow is specialised in developing biosafety testing technologies for vaccine and bio-therapeutics for drug manufacturing companies from the cGMP/cGLP certified, MHRA and US FDA registered laboratory. The team pioneered the development of PCR, DNA sequencing, electron microscopy, cell culture assays for biologic medicines under GMP.
SGS’ experts provide testing support for the characterisation, biosafety and release of all globally available commercial viral vaccines and biologic medicines.
- Novel vaccines with a viral seed or recombinant vector manufacturing system in cells or eggs – Cell bank and vaccine seed/bulk biosafety and characterization testing – rapid molecular assays, including testing to meet USP, Phar, Eur, FDA, WHO vaccine guidelines
- Novel vaccines based on purified recombinant antigens from continuous cell manufacturing systems (e.g. Microbial, CHO, Sf9, HEK293, NS0 etc.) - cell bank / bulk characterization and biosafety
- Novel vaccines based on nucleic acids e.g. RNA or DNA plasmids – Cell bank testing, DNA sequencing, and nucleic acid QC testing
- Integrated vaccines solutions from preclinical activities to phase I-IV clinical trials
SGS Life Sciences leverages its digitalised network of laboratories, present in North America, Europe and Asia-Pacific, to deliver harmonised testing solutions for analytical development, biologics characterisation, biosafety and quality control, as well as clinical research to large pharmaceutical and biotechnology firms.
