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New Paper on Using ADCC Assays to Prove Comparability of Biosimilars

publication date: Dec 2, 2015
author/source: Sartorius Group

Presents data on factors that affect the sensitivity of ADCC assays and discusses how to optimise methodology

sartoriusSartorius Stedim Biotech (SSB) BioOutsource today announced a new paper entitled, ‘As easy as ADCC’ has been published in the respected journal, European Biopharmaceutical Review. The article outlines the factors affecting the use of antibody-dependent cell-mediated cytotoxicity (ADCC) assays and discusses when to use different types of ADCC assays to guide the design of biosimilar drugs and determine comparability.

This informative paper describes how effector cell composition can influence biological relevance and sensitivity of the ADCC assay by comparing five different effector cell preparations.  The comparison is discussed in the context of sensitivity to Fc-glycans and biological relevance and provides scientists with a guide as to which effector cells to consider when assessing the ADCC activity of their biosimilar. 

The article also details how an ADCC assay’s sensitivity can be influenced by the Fc?IIIa receptor polymorphisms expressed on effector cells. A comparison of three effector cell types and the effects that three different polymorphisms can have on ADCC activity is described.

In summary, the paper is a good overview of ADCC assays for an accurate comparison of biosimilars to innovator molecules, and may also help guide scientists with their design process to create antibodies that target specific activity.

To request free access to this paper, scientists should click the link: 

The author of the paper, Andy Upsall, Director of R&D and Technical Services at SSB BioOutsource explained: “Biosimilar development continues to grow worldwide and scientists are being required by regulators to use sensitive analytical characterisation tools such as ADCC assays to prove comparability between innovator and biosimilar drugs.” 

Upsall added: “This new paper helps scientists understand some of the complex issues surrounding what affects the performance of an ADCC assay. The data presented demonstrates the importance of effector cell composition and Fc?IIIa receptor polymorphisms so utilising this information will help guide scientists to select the correct ADCC assays to accelerate their biosimilar development.” 

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