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Sartorius Stedim BioOutsource Introduces New Released N-Glycan Assay

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In-depth profiling of IgG glycosylation coupled with ADCC assays enables generation of robust biosimilar comparability data

Glasgow, UK, July 7, 2016 / B3C newswire / -- Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, announced the launched of a new Released N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay, developed by SSB’s subsidiary BioOutsource and offered in combination with its unique Antibody Dependent Cell Cytotoxicity (ADCC) assay platform, combines data on the molecular structure with a key therapeutic mechanism of action.  This will generate comprehensive, highly accurate biosimilar comparability data, driving shorter drug development timelines.

The new N-Glycan Assay is one of a range of orthogonal methods, including analysis by CD16a (FcgammaRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suitable for regulatory submissions. 

BioOutsource’s new assay involves enzymatically-removing glycans from the antibody, functionally derivatizing them and separating the glycans by UHPLC. The glycans are then identified by on-line electrospray ionization mass spectrometry (ESI-MS), enabling confident assignment and precise quantification of the different structures.

Dr. Daniel Galbraith, Chief Scientific Officer at Sartorius Stedim BioOutsource, explained: “The structural classification and monosaccharide composition of carbohydrates attached to the constant region of therapeutic biosimilar antibodies is key to their binding. An accurate understanding of these glycans ensures effective selection of biosimilars that have the optimum ADCC activity to destroy tumor cells.”

Galbraith continued: “Our new Released N-Glycan Assay coupled with our ADCC assays will help deliver this understanding by providing robust biosimilar characterization data suitable for the regulators, thus enabling efficient drug development and more rapid entry into clinical programs.”

To find out about BioOutsource’s new Released N-Glycan Assay and complementary ADCC assays, scientists should click this link: www.biooutsource.com/glycan-analysis/

Photo

N-Glycan

Caption: Sartorius Stedim BioOutsource facilities in Glasgow where the new released N-Glycan assay has been developed for in-depth profiling of IgG glycosylation. 
For high resolution please click the image.


A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves.

Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 million euros.

A profile of Sartorius Stedim BioOutsource Ltd.
Sartorius Stedim BioOutsource provides contract testing services to the biopharmaceutical industry. Our core offering includes a comprehensive range of services to support the testing of biologics, vaccines & biosimilars throughout their development. We possess an unparalleled combination of commercial, regulatory and technical knowledge that enables us to truly stand out as the industry’s increasingly preferred testing partner. We understand the importance of our service to support our client’s critical testing requirements and as a result, continually strive to provide a world class service globally. 


Contacts

Dominic Grone
Senior Manager Corporate Communications
Sartorius Corporate Administration GmbH
Goettingen, Germany
Phone: +49. (0)551.308.3324
Fax +49. (0)551.308.3410
This email address is being protected from spambots. You need JavaScript enabled to view it.
www.sartorius-stedim.com

Gemma Fulton
Marketing Manager
Sartorius Stedim BioOutsource Ltd
Glasgow, United Kingdom
Phone: +44(0)141.946.4222
Fax +44(0)141.946.4552
This email address is being protected from spambots. You need JavaScript enabled to view it.
www.biooutsource.com

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