Sartorius Stedim's New Testing Services to Focus on mAbs and biosimilars

Sartorius Stedim Biotech has launched a new chemistry testing service in Glasgow, United Kingdom to offer physicochemical properties characterization and structural attributes testing for mAbs and biosimilars. Its goal is to help ensure faster sample analysis and reporting for biopharmaceutical clients.

This range of testing available is said to comply with guidelines set by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH’s) Q6B scientific guidelines, including:

• Methods for characterizing protein structure

• Carbohydrate profile testing

• Testing for post-translational modifications and impurities, using ultra high pressure liquid chromatography (UHPLC) and liquid chromatography/mass spectrometry (LC/MS) instruments.

The launch required expanding laboratory space in Glasgow by 340 m2 and hiring scientists with extensive experience in these specialized testing areas.

The company sees this new capacity as complementing its existing range of off-the-shelf biological assays for biosimilar products, allowing it to serve as a “one stop” service provider, and allowing structural and functional analyses to be conducted in parallel to deliver a comprehensive data package for regulatory submissions.

“Rapid data-driven decisions at critical stages are crucial for the successful development of biosimilars," said 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.

For more information, please visit Biooutsource's new webpage.