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New Paper on using ADCC Assays to Prove Comparability of Biosimilars

Sartorius Group

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

10 Nov 2015
Lois Manton-O'Byrne, PhD
Executive Editor

Industry news

Sartorius Stedim Biotech (SSB) BioOutsource has 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 FcᵧIIIa 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. Request free access to the paper here.

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 characterization 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 FcᵧIIIa receptor polymorphisms so utilizing this information will help guide scientists to select the correct ADCC assays to accelerate their biosimilar development.”

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.Cell / Tissue CultureCell culture or tissue culture is used to study the biology of cells or tissues and to isolate cellular products in an environment which can be manipulated and well defined. Accurately control your culture environment with bioreactors or culture incubators, bind your cells to a surface or together with an extracellular matrix. Distinguish cell types with differential media or proliferate cells with certain characteristics using selective media. Enrich your media with supplements such as growth factors, sera and vitamins. Find the best cell and tissue culture products, kits and equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.GlycansActive PharmaceuticalsThe Active Pharmaceutical Ingredient (API) of a drug is the component that causes the direct effect of the product. The remaining inactive components are known as excipients.CytotoxicityCytotoxicity assays measure the toxic effects of substances on cells, often used in drug testing and environmental studies. These tests are crucial in determining the safety of chemicals and pharmaceutical compounds. Explore cytotoxicity testing tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.

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