SGS introduces new bio-layer interferometry analysis for biopharmaceutical development

This new service offers a number of advantages compared with current analytical techniques.

BLI utilizes the principle of optical interferometry to generate real time binding curves. An optic fiber is coated with a specific capture molecule, such as a monoclonal antibody, and binding of a target analyte to the biosensor is monitored using an algorithm which then converts interference patterns into a binding curve. This method can be used to study interactions between most types of molecules, such as protein-protein, protein-small molecule, antibody-peptide, DNA-protein or DNA-DNA. The data generated by the newly installed instrument is 21 CFR part 11 compliant to ensure integrity of information for regulatory submissions. “BLI is a strong addition to the existing services that SGS offers for protein quantitation, molecular binding affinity and kinetic analysis,” commented Mike Lindsay, Vice President Life Sciences, SGS Canada. “This new technique enhances our ability to offer more robust, high-throughput, cost efficient and complete solutions to assist with candidate selection and assist in the drug-to-market process.”

In comparison with other techniques, BLI is easier to use, more cost effective and more tolerant of samples in complex mixtures, such as media and lysates. For molecular binding affinity/kinetics analysis, BLI provides rate and affinity constants in minutes, allowing for a high throughput method with small volumes. Additionally, protein quantitation can be performed over a large dynamic range (ng/mL to mg/mL), and samples do not need to be purified or diluted, reducing handling and assay time, and enhancing the accuracy of results. Furthermore, the BLI method conserves valuable samples as it is label-free and non-destructive.

The investment in BLI at its Mississauga facility comes after the December 2015 announcement of the acquisition of Quality Compliance Laboratories Inc., which expanded SGS’s comprehensive service provision in the analytical testing of pharmaceutical and biopharmaceutical products, raw materials and packaging, and medical devices capacity from its three laboratories in Canada.