This new service, which is currently undergoing installation, will complement the existing competencies within SGS's global network of laboratories to support clients in the full characterization of biological molecules, including biosimilars. SGS will be one of the first service providers to offer HDX-MS in a cGMP environment.
HDX relies on proteins being exposed to deuterium water (D2O) at extremely low temperatures, whereby hydrogen atoms on the outside of a folded protein molecule exchange with the deuterium atoms in the water in equilibrium. By analyzing the peptides on which the atoms have been exchanged, detailed information on the protein folding can be obtained. In the case of biosimilar comparison analysis, even subtle differences with originator molecules can be unraveled.
“As a service provider, it is important that we offer our clients the most modern and up to date techniques that would either be impractical, or unfeasible, for them to install in house,” commented Mark Rogers, Vice President Life Sciences, SGS USA. “HDX-MS is a high-end method in protein characterization which provides information that no other technique can currently supply, and from a regulatory point of view, we are seeing more and more submissions containing HDX-MS data, with authorities demanding ever increasing amounts of analysis, especially in the area of biosimilar development.”
The HDX-MS service is expected to be introduced in Q3 2016 at the West Chester facility following investment in 2015 to increase the array of services for higher order protein analysis at the site, including Circular Dichroism (CD), Analytical Ultra Centrifugation (AUC), Size Exclusion Chromatography with Multi-Angle Laser Light Scattering (SEC-MALS), and Fourier Transform Infrared Spectroscopy (FTIR).
With 20 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 Phase I-IV clinical trial management, and services encompassing data management and statistics, PK/PD modeling and simulation, pharmacovigilance and regulatory consultancy.