Chemistry Testing Services Available from SSB

A full range of chemistry testing services available through SSB subsidiary Sartorius Stedim BioOutsource, offer characterisation of the physicochemical properties and structural attributes of therapeuticmonoclonal antibodies (mAbs).

The new service complies with the well-established ICH Q6B scientific guidelines for pharmaceuticals for human use, including methods to characterise protein structure, carbohydrate profile, post-translational modifications and impurities utilising UHPLC and LC/MS instruments. To provide these services, SSB has expanded laboratory space by 340 square meters at its facility in Glasgow, UK and has appointed new scientists with extensive chemistry testing experience. “Rapid data-driven decisions at critical stages are crucial for the successful development of biosimilars. Our chemistry testing services enable biosimilar manufacturers to benefit from side-by-side biological and physicochemical analyses to gain the in-depth characterisation data required,” explained Dr. Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource. “Expanding our portfolio with these new services was a logical step following the successful launch of our Released N-Glycan assay in 2016,” he added.