10.28.14
SGS Life Science Services has completed the expansion of its 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 lab enhances capacity and capabilities for cell culture testing, adding 500 m² to SGS’ existing centre of excellence for viral safety, which now totals 1,124 m².
The lab employs approximately 45 scientific and quality personnel, and 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.
The facility is equipped with Surface Plasmon Resonance (SPR) BiaCore T200 equipment to facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.
The new lab 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. Additionally, 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,” said 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.”
The lab employs approximately 45 scientific and quality personnel, and 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.
The facility is equipped with Surface Plasmon Resonance (SPR) BiaCore T200 equipment to facilitate off the shelf and customized binding kinetics, and potency measurement of monoclonal antibodies and other recombinant protein-based biological medicines.
The new lab 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. Additionally, 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,” said 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.”