SGS Life Science Services, the leading pharmaceutical analytical and bioanalytical contract solutions provider, today announced the completion of its expanded facility in Glasgow, UK, for the testing of cell banks for vaccines, gene and cell therapies, monoclonal antibodies and other recombinant protein based biological medicines. The new laboratory adds an additional 500 m2 and will be adjacent to SGS’s existing center of excellence for viral safety, now totaling 1,124 m2, with the enhanced capacity and capability in cell culture testing.
Employing more than 45 scientific and quality personnel, the lab will offer a full range of validated bioanalytical methods to support the manufacturing, biopharmaceutical stability and lot release of drug product, including host cell protein, endotoxin, ELISA, western blotting and residual impurity testing. These methods are now accessible via a new web-based tool at SGS Bio/Analytical Methods page.
Scientific expertise and Surface Plasmon Resonance (SPR) BiaCore T200 equipment located within the facility will facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.
The new laboratory will also offer nucleic acid sequencing technologies and enhanced real-time PCR platforms to support viral safety and genetic stability assessment of cell banks for vaccines, gene and cell therapies. In addition, to meet pharmacopeial requirements, SGS will undertake validated PCR assays for detecting mycoplasma contamination during drug product manufacturing.
“As the pharma industry becomes increasingly focused on large molecule biologics, so we are increasing our service capacity and capabilities in this area,” commented Archie Lovatt, Scientific Director at SGS Life Science Services. “This is a rapidly expanding field where much broader and highly specialized testing expertise and equipment are required, to establish the safety of novel human therapies and vaccines, and one which we see as key to our strategic growth.”
Earlier this year, in January, SGS Life Sciences announced that it was officially launching its new service offer for the integrated formulation and stability testing service for biologics from its state-of-the-art 7,000 ft2 laboratories in Wokingham, UK.
With 21 laboratories offering contract analytical and bioanalytical services, SGS leverages its wholly-owned global network, present in North America, Europe, and Asia, to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.
For further information, please contact:
Global Marketing Director
Life Science Services
75 Passaic Avenue,
Fairfield, NJ 07004, USA
6 Penny Black Chambers,
Manchester M28 2PD, UK
t: +44 (0) 161 728 5880
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.