Please register using the link below for the webinar on September 21st at 1 PM EDT presented by Professor Paul Darby and Professor Hristo Svilenov on the Influence of Excipients and Co-Formulation on Protein Stability and Aggregation.
Influence of Excipients and Co-formulation on Protein Stability and Aggregation | AAPS (pathlms.com)
DESCRIPTION
The co-formulation of biologics, particularly "cocktails of monoclonal antibodies (mAbs)", is gaining lot of interest within the Pharmaceutical Industry as evidenced by increasing number of active clinical trials and recent regulatory approvals of several co-formulated biologics products. Mixing different therapeutic proteins could adversely affect their stability, and reduce the shelf life of each individual component, making the control of such products very challenging. It remains unclear to what extent mAbs with different physicochemical properties can be combined in solution without detrimental effects on protein stability. There are very few published articles on the topic with limited knowledge and information to the scientific community.
During this webinar, we will discuss outstanding challenges and opportunities for the co-formulation and stabilization of mAb combinations. While we present a few co-formulation case studies, the attendees will also hear about orthogonal analytical methods that are appropriate for the characterization of mAb mixtures.
The content of the webinar will be highly relevant for scientists and managers involved in the development of antibody drugs.
Learning Objectives:
- Learn about co-formulations of therapeutic antibodies
- Understand challenges in developing antibody co-formulations
- Get acquainted with analytical approaches to study antibody stability in co-formulations
CONTRIBUTORS
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Professor Paul Dalby
Prof Paul Dalby is Co-Director of the EPSRC Future Targeted Healthcare Manufacturing Hub, and Deputy Head of the Department of Biochemical Engineering at University College London (UCL). The Hub is developing new processes, analytical technologies and digital approaches for the manufacturing, formulation, and delivery of personalized ATMPs and stratified biologics. Paul's research combines protein engineering and formulation, with biophysical characterization, molecular modelling, and simulation, to understand the factors that influence therapeutic protein and vaccine stability, and to improve their developability.
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Professor Hristo Svilenov
Hristo Svilenov is a professor of biopharmaceutical manufacturing technology and formulation in the Laboratory of General Biochemistry and Physical Pharmacy at Ghent University, Belgium. Before moving to Ghent, he spent two years as a postdoc at the Chair of Biotechnology (Prof. Johannes Buchner), Technical University of Munich funded by a fellowship from the Peter und Traudl Engelhorn Foundation and a grant from the Else Kröner-Fresenius Foundation. From 2016 to 2019, he did his Ph.D. (summa cum laude) sponsored by a Maria Skłodowska-Curie fellowship in the group of Prof. Gerhard Winter at the Ludwig Maximilian University of Munich. For his research, Dr. Svilenov received several prizes like the Carl Wilhelm Scheele Award from the German Pharmaceutical Society (DPhG) or the Abbvie Award for the best doctoral thesis. Before starting his PhD, he worked as a research scientist in a German biotech company and as a teaching assistant at the Medical University – Sofia where he graduated as a pharmacist in 2012.
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Srivalli Telikepalli Ph.D.
Research Chemist
National Institute of Standards and Technology
Gaithersburg MD
[email protected]
Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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