A Quality by Design approach to de-risk biosimilar development
Biosimilar drugs have become a mainstay of modern medicine with the latest reports stating the global market could reach $55 billion by 2020. The ever evolving landscape has led to different approaches to biosimilar development over the years.
Many sponsors now prefer a linear, orthogonal approach to biosimilar development starting at an early stage in an effort to de-risk the development pathway. In this webinar we will look back on the lessons learned from the past 10 years of biosimilar development and discuss how a Quality by Design (QbD) approach can help avoid costly mistakes, de-risk development and ultimately improve speed to market.
The webinar will firstly explore the evolution of the biosimilar development pathway and the importance of characterizing the reference product over time to set the design space. Effective quality systems should be a key consideration from early stage development, as it is unknown which assays will be selected for lot release of the product, thus attention should be paid to generating data suitable for regulatory submission.
Drawing on case studies and in-house R&D data, the webinar will highlight the importance of understanding structure and functional relationships of a monoclonal antibody and how this data can aid decision making at critical stages of biosimilar development. An in-depth exploration of this relationship will focus on the following structural and physicochemical attributes: glycan analysis, charge variants and aggregates and how they affect the functional activity of a monoclonal antibody.
Join this webinar to develop a deeper understanding of how structure affects the functional activity of monoclonal antibodies and how this can be used to make data-driven decisions throughout development. Learn more about the evolving biosimilar development pathway and how a QbD approach ensures a step-wise, orthogonal process to de-risk development and improve speed to market.
Presented by
Dr. Terry Gray,
Bioanalytical Field Marketing Specialist
Terry joined BioOutsource in 2013 following successful completion of a PhD in Oncology and Cell Signalling at Edinburgh Cancer Research Centre, University of Edinburgh. Specialising in protein science, protein-protein interactions and monoclonal antibodies, Terry focussed on the development, optimisation and validation of binding and functional assays to characterise biological drugs in his role as Technical Services Scientist.
His current position as Bioanalytical Field Marketing Specialist builds on a rounded understanding of monoclonal antibodies, with an emphasis on understanding the relationship between biological activity and molecular structure. In addition, he currently provides technical support for our broad and expanding range of bioanalytical and physicochemical characterization services.
Dr. Graeme Anderson ,
Biochemistry Senior Scientist
Graeme joined Sartorius Stedim BioOutsource in 2016 and has spent many years within the biopharmaceutical industry, gaining a broad depth of knowledge of lot release testing, stability and routine testing of client materials within other CROs.
Graeme completed a PhD in Pharmaceutical Chemistry at the School of Pharmacy, University of London and spent several years lecturing and in academic research. Experienced in the purification, structural analysis and physicochemical characterization of peptides and proteins, he is the Senior Scientist within the Biochemistry group, focusing on physicochemical testing of client biosimilar and related molecules.
