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Live Webinar: Future-Proof Your Biotherapeutic Development with Next-Gen CE Analytical Tools


January 19, 2022 @ 12:00 PM ET

Part 1
Optimized, Automated CE-SDS for Evaluating Oncolytic Coxsackievirus Capsids
Speaker: Mohamed Dawod, Ph.D., Senior Scientist, Vaccine Analytical R&D

Currently in Phase I/II clinical trials and classified as an investigational oncolytic agent, Coxsackievirus A21 (CVA21) is being investigated against a range of solid tumors. The mature (full) capsid consists of four viral proteins, VP1, VP2, VP3, and VP4, while immature (empty) capsids have only precursor VP0, VP1, and VP3 proteins. Key challenges for successful scale-up of the manufacturing process include optimization of virus production, separation of empty and full capsids, and purification. This portion of the webinar discusses the development of a CE-SDS method on a Sciex CE instrument for profiling viral proteins using a custom-made gel, followed by the development a CE-SDS method with optimized sample loading on a Maurice instrument from ProteinSimple. The CE-SDS using Maurice provided acceptable signal intensity with baseline resolution for all 5 viral proteins. The optimized method was qualified and applied for analysis of various process batches for profile and relative purity consistency.

Attendees will learn about a faster, more efficient identity profiling and testing of downstream vaccine materials.

Part 2
A Global Intercompany Precision and Robustness Validation of icIEF methodology for the Analysis of a mAb and a Fusion Protein
Speaker: Seth Madren, Ph.D., Scientist II, Analytical Development, Biogen

The next part of the webinar will describe a global, multi-company study that compared the precision and robustness of an imaged cIEF method for the analysis of the NIST monoclonal antibody and a fusion protein, PD-L1-Fc, on the iCE3 and the Maurice instruments. 21 sites, including pharmaceutical and IVD companies, and a regulatory agency, participated in this study. This information has been updated most recently and is widely requested to help companies better understand how to evaluate the instruments with these key parameters and transition to the newer technology, Maurice.

Attendees will learn about how the iCE3 and Maurice compare relative to precision and robustness and how Maurice can be easily adopted as go-to method for icIEF detection.


Speakers

Mohomed Dawod

Mohamed Dawod, Ph.D.
Senior Scientist
Vaccine Analytical R&D


Mohamed Dawod is an expert in capillary and microchip electrophoresis. With over 10 years of post-PhD work in academia and industry, his career has focused heavily on the enhancement of detection sensitivity and quantitative repeatability of capillary and microchip electrophoresis and microfluidic Western blotting. Dr. Dawod is a Senior Scientist in Vaccine Analytical R&D (VARD) and is the founder and lead of CE Center of Excellence within Merck. He is also the co-lead of Scientific Excellence within VARD. He has effective collaboration with peers and industrial partners in research grants and has generated more than 20 peer reviewed articles

Seth Madren
Seth Madren, Ph.D.
Scientist, Analytical Development
Biogen


Seth Madren, a Scientist II in the Analytical Development group at Biogen, received his doctoral degree in Analytical Chemistry from Indiana University at Bloomington where he focused on the fabrication and use of microfluidic devices. After graduate school, Seth joined Biogen, where he has worked for 8 years. While at Biogen, he focused on the development of novel methods to characterize monoclonal antibodies with a wide range of analytical techniques. Seth has been responsible for method development, troubleshooting and the evaluation of novel analytical platforms. Seth is an expert in a wide range of electrophoretic and chromatography-based separations.



Webinar: Next-gen CE platform for characterization of an oncolytic virus, a monoclonal antibody, and a fusion protein.