Biophysical Society 66th Annual Meeting Program Guide

Esplanade, Room 158: Tuesday, February 22 10:30 AM – 12:00 PM Malvern Panalytical A Biophysical Toolbox To Predict and Assess the Stability of Biopharmaceuticals and Vaccines The ability to characterize the stability of biotherapeutic products is crucial to the successful development of commercially successful and safe biopharmaceuticals. As a consequence, protein aggregation is rec - ognized by regulatory agencies and the biopharmaceutical industry as a key quality attribute for biotherapeutic products. During this presen - tation we will introduce the origins and consequences of aggregation in biotherapeutics and examine strategies for predicting and quantify - ing aggregation in biopharmaceutical formulation development. In addition to traditional protein-based therapeutics, we will also cover vaccine development and stability assessment. A vaccine is a biological preparation that provides active acquired immunity to an infectious disease using the causative agent or components of it, to act as antigen inducing antibody without inducing the actual disease. We will introduce vaccine development, address the key challenges associated with each development platforms and introduce the state of the art analytical and biophysical technology solutions. Speakers Matthew McGann, Pharma & Food Territory Manager, Malvern Panalytical Ronald Soriano, Applications Scientist, Pharma & Food, Malvern Panalytical

12:30 PM – 2:00 PM Fluidic Analytics

Introducing Microfluidic Diffusional Sizing (MDS) Technology; Quantify and Characterize Any Protein Interaction – Even In Complex Backgrounds, Even With Challenging Targets Studying protein interactions is of fundamental importance in a wide variety of research fields, including neurobiology, oncology, immunol- ogy, structural biology, and molecular biology. The more scientists understand about protein interactions, the more we will know about the inner workings of a cell, and crucially, the bet- ter we will understand what happens when normal cellular function is subverted in human disease. But, with a multitude of different tech- nologies on the market, how do researchers know which technique is right for them? Microfluidic Diffusion Sizing technology (MDS) brings a new tool to the analytical characterization toolbox: a different approach that enables the analysis of protein interactions close to in vivo conditions. Measuring What Matters Scientists can now determine affinity of interaction ( K D), concentration of bound protein, and stoichiometric information, in solution, and all in a single experiment, whether using simple biological buffer systems or complex backgrounds such as serum, plasma, saliva, and cell lysates. The MDS technology enables quantification and characterization of any protein interaction – even in complex backgrounds or with challenging targets: • Characterize polyclonal antibodies • Track functional immune response in serum samples • Reveal therapeutic antibody / protein interaction mecha - nisms • Characterize disordered proteins or higher-order complexes under close to in vivo conditions • Explore aggregation effects and distinguish between specific and non-specific binding During our presentation we will describe a series of case studies and collaborations with pioneering researchers covering such topics: • Elucidating mechanism of action of Aducanumab in Al - zheimer’s Disease A collaboration with Professor Sara Linse, University of Lund, Sweden • MDS enables the investigation of viral variants in infectious disease; A collaboration with Professor Akiko Iwasaki, Yale University School of Medicine Howard Hughes Medical Institute • Characterizing the immune response to viral infections: A collaboration with Professor Adriano Aguzzi University Hospital Zurich and Professor Tuomas Knowles University of Cambridge • In-Solution Affinity Measurement of a Drug-Induced Protein Complex Speaker Molly Coseno, Field Application Specialist, NE, Fluidic Analytics

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