Cutting edge insight into the challenges of Biosimilar comparability studies
As the biosimilar market continues to grow, and with recent FDA draft guidelines describing a requirement for “fingerprint like similarityâ€, it is essential for those developing biosimilars to be able to detect differences between molecules. This is a complex process and a key challenge is understanding the most appropriate combination of methods to demonstrate biosimilarity. It is increasingly important for biosimilar developers to take advantage of the vast pool of experience and technical knowledge of biosimilar molecules residing in specialist contract testing organisations.
This webinar will explore in detail the current comparability challenges faced by those developing biosimilars. The webinar will have a specific emphasis on the importance of undertaking a comprehensive and orthogonal characterisation process using assays capable of detecting differences between molecules.
Drawing on real life examples throughout, the presentation will focus on a case study of the methods used to detect differences between Bevacizumab (Avastin®) and Ranibizumab (Lucentis®) molecules. Data will be presented from multiple in vitro assays which characterise the binding of Bevacizumab and Ranibizumab to Vascular Endothelial Growth Factor (VEGF)-A. These assays comprise a range of ELISA, cell-based and Biacore-based methodologies, each contributing to the overall comparability picture.
The webinar will also seek to inform participants on the regulatory framework for the development of biosimilars based on our experience in generating data for presentation to the FDA and EMA regulatory bodies. For anyone involved in biosimilar development, the webinar will provide an in-depth insight into how we may approach your comparability studies of biosimilar molecules using a panel of appropriate methods.
BioOutsource are uniquely placed to offer a specialist service, combining vast experience and technical knowledge with a consultative approach ensuring an efficient, cost effective and quality-driven process. Using a range of cutting edge technologies and analytical techniques combined with our vital regulatory knowledge, we can add value to your biosimilar development process. Register today and learn how BioOutsource's innovative approach can resolve your comparability challenges.
Presented by
Sarah Stone,
Scientist - Biosimilars
Dr. Sarah Stone joined BioOutsource Ltd in 2012, following a successful academic career, and quickly became a key member of the Biosimilars department. During a period of rapid growth for the company, Sarah developed expertise in the characterisation of biosimilar monoclonal antibody-based therapies for some of the blockbuster molecules, including Rituximab, Etanercept, Adalimumab, Trastuzumab and Bevacizumab; using SPR-based technologies, namely the Biacore T200 and Biacore 4000 systems.
Currently, Sarah leads the Biacore department at BioOutsource, working on a wide range of commercial and R&D projects to develop a range of new Biacore assays. Although initially focussed on characterisation of Fc binding characteristics, the work of the department has increasingly started to focus on the challenges of analysing the high affinity Fab-antigen interaction which can be particularly problematic for receptor-Fc fusion proteins and affinity matured molecules.
Andrew Baron,
Scientist - Biosimilars
Andrew joined BioOutsource in 2012 after completing a PhD in neuroscience and spending time working for Covance and Roche. With experience in in vitro assays, in vivo research and clinical trials, Andrew initially worked at BioOutsource as an assay development scientist responsible for the development, optimisation and validation of cell based assays as well as ELISA, MSD and SPR methods for use in the characterisation of a range of biological drugs. He progressed to the role of study manager after developing some of BioOutsource's most popular off-the-shelf assay packages to support Biosimilar development. He now leads a dedicated team performing bioassays and binding assays in BioOutsource's Biosimilar Centre of Excellence.
