Rapidly reveals the factors to consider when using ADCC assays for producing precise biosimilar comparability data

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.

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.”

more about sartorius group

more news from sartorius group