How Providing Comprehensive Data Can Accelerate Drug Development
Glasgow, UK – April 21, 2016: Sartorius Stedim BioOutsource today announced that its scientific experts will be presenting a live webinar about optimizing biosimilar analysis on Thursday, June 2, at 3 pm BST, 10 am EDT. The webinar is essential listening for researchers who want to understand how to select optimal clones and processes to accelerate development of their biosimilars.
During the one-hour webinar, Dr. Martin De Cecco, and Dr. Terry Gray will explore the impact of differing glycan structures on antibody function using a case study comparing biosimilar infliximab to the innovator molecule Remicade®. Drawing on real-life examples, both experts will discuss a variety of orthogonal methods, including glycan analysis by LC-MS, CD16a and SPR binding, as well as ADCC activity that will highlight the benefits of performing combined structural and functional analysis. They will also be discussing the importance of choosing appropriate analytical assays at each stage of the product’s development and how utilizing a comprehensive testing package can provide evidence suitable for regulatory submissions to enable biosimilars to enter clinical programs more rapidly.
To register for this informative webinar and receive a recording to listen to on demand, scientists should click the link: http://www.business-review-webinars.com/webinar/Pharma/Orthogonal_Analytics_for_Biosimilars-g2zTPRKH
Dr. Daniel Galbraith, Chief Scientific Officer of Sartorius Stedim BioOutsource, stated: “The complex nature of monoclonal antibodies often results in differences between the biosimilar and innovator molecule and the key to regulatory acceptance is understanding the potential clinical significance of those residual differences. We’re delighted to be hosting a webinar during which our experts will explain how generating comprehensive characterization data for the regulators can overcome reservations about a new monoclonal, to deliver faster and more cost-effective biosimilar drug development.”
A profile of Sartorius Stedim Biotech
Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves. Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted 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 global reach. The company employs approx. 4,200 people, and in 2015 earned sales revenue of 884.3 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.
