Follow us on
Search News Archives
Monthly Newsletter

News Channels

 

New Laboratory Products

 

Lab News

 

Microscopy & Image Analysis

 

Separation Science

 

Videos

 

Research & Case Studies

 

Literature

 

Events | Webinars

 

 

 

Conferences | Events

Sartorius Stedim BioOutsource Introduces New Released N-Glycan Assay

publication date: Aug 15, 2016
 | 
author/source: Sartorius Group

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

Sartorius Stedim BioOutsource facilities in Glasgow where the new released N-Glycan assay has been developed for in-depth profiling of IgG glycosylation. 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 (FcγRIIIa) 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.”


more about sartorius


more news from sartorius


 

 

 


If you have not logged into the website then please enter your details below.



 

 

Popular this Month...

Our Top 10 most popular articles this month

 

Today's Picks...

 

 


 

Looking for a Supplier?

Search by company or by product

 


Company Name:

Product:


 

 

Please note Lab Bulletin does not sell, supply any of the products featured on this website. If you have an enquiry, please use the contact form below the article or company profile and we will send your request to the supplier so that they can contact you directly.

Lab Bulletin is published by newleaf marketing communications ltd

 


Promotions

 

Media Partners