New Paper on using ADCC Assays to Prove Comparability of Biosimilars
Presents data on factors that affect the sensitivity of ADCC assays and discusses how to optimise methodology
Glasgow, UK – November 10, 2015: Sartorius 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 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.
To request free access to this paper, scientists should click the link: http://www.biooutsource.com/resources/as-easy-as-adcc/
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 FcᵧIIIa receptor polymorphisms so utilising this information will help guide scientists to select the correct ADCC assays to accelerate their biosimilar development.”
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading provider of cutting-edge products and services for the development, quality assurance and production processes of the biopharmaceutical industry. Its integrated solutions covering fermentation, cell cultivation, filtration, purification, fluid management and lab technologies are supporting the biopharmaceutical industry around the world to develop and produce drugs safely, timely and economically. Sartorius Stedim Biotech focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Strongly rooted in the scientific community and closely allied with customers and technology partners, the company is dedicated to its philosophy of “turning science into solutions.”
Headquartered in Aubagne, France, Sartorius Stedim Biotech is listed 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 worldwide presence. Its key manufacturing and R&D site is in Germany. The company employs approx. 3,700 people, and in 2014 earned sales revenue of 683.5 million euros.
A profile of Sartorius Stedim BioOutsource Ltd.
Now part of Sartorius Stedim Biotech Group, 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.
Gemma Fulton; Marketing Manager, Sartorius Stedim BioOutsource Ltd, Glasgow, United Kingdom
Phone: +44(0)141.946.4222; Fax +44(0)141.946.4552
Dr Sue Pearson, Director, International Science Writer