New Video on ADCC Assays from BioOutsource
Rapidly reveals the factors to consider when using ADCC assays for producing precise biosimilar comparability data
Glasgow, UK – November 17, 2015: Sartorius Stedim Biotech (SSB) BioOutsource today announced a new video is now available on-line explaining how to overcome the issues associated with using antibody-dependent cell-mediated cytotoxicity (ADCC) assays. The bite-sized video outlines the factors affecting the use of ADCC assays and discusses what to consider when determining comparability and designing biosimilar drugs.
In just five minutes, bioassay development experts, Dr Catriona Thomson and Dr Daniel Galbraith describe in this engaging video the challenges of using ADCC assays and explain when to use the different types of assay to assess biosimilars.
Dr Thomson lists four key reasons why ADCC activity is the greatest road-block to achieving approval of biosimilars and, with real ADCC assay data, shows what a biosimilar which has poor comparability to the innovator molecule looks like.
Dr Daniel Galbraith then rapidly reveals the science behind ADCC assays and describes with real data how different types of effector cell can dramatically affect biological relevance and sensitivity. This provides scientists with a quick snap-shot as to what ADCC assay format is most relevant for the current stage of their biosimilar’s development.
In short, the video offers researchers an excellent resource that they can view on their smartphone, tablet or computer of factors to consider when using ADCC assays for an accurate comparison of biosimilars to innovator molecules.
To access the informative video, scientists should click this link now: http://ow.ly/UvNBj
Dr Daniel Galbraith, Chief Scientific Officer of BioOutsource commented: “Having a biosimilar and an innovator molecule with different ADCC activity can result in costly changes to the manufacturing process and delays with regulatory approval. It is therefore vital to understand at the earliest stage of development the types of ADCC assay available to prove comparability.”
Galbraith continued: “We’re delighted to make this new video available as it explains in simple terms some of the complicated technical factors that affect how an ADCC assay will perform. Scientists that watch the video will have a better understanding of ADCC assays and this will help guide them to methodologies for developing biosimilars with fingerprint like similarity to the innovator molecule.”
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