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Upcoming Webinars

Characterizing quality attributes and other characteristics of biologics, vaccines, and gene vectors is essential at each stage of its discovery, development, production, and quality control. Analytical techniques based on light scattering have become powerful tools for characterizing various attributes include molar mass, size, aggregation, physical titer, thermal and colloidal stability.    In this webinar, we highlight robust, reliable, simple, quantitative, and fast ways to use three different light scattering techniques - batch dynamic light scattering (DLS), static light scattering (SLS), and massively parallel phase analysis light scattering (MP-PALS) - to characterize the stability of vaccines and gene therapeutic nanoparticles.    Key Learning Objectives: Basic DLS and MP-PALS theory and instrumentation  How DLS and SLS are applied to study the stability of AAVs and vaccines  How DLS and MP-PALS characterize the stability of lipid nanoparticles  How high-throughput formulation and stability studies are carried out with these techniques  Who Should Attend: Pharmaceutical scientists involved in analytical characterization and formulation of proteins, monoclonal antibodies, and gene therapeutic nanoparticles Scientists and managers in need of robust, reliable, simple, and fast methods for evaluating biophysical properties and stability Managers of academic labs and core facilities developing viral vectors and LNPs   Brought to you by:   Xujun Zhang, Ph.D. Application Scientist, Wyatt Technology Ann Thayer Contributing Editor, C&EN Media Group
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In the development of biotherapeutics, a thorough understanding of a molecule’s product quality attributes (PQAs), and their effect on various structure-function relationships and long-term stability, is essential for ensuring the safety and efficacy of the product. At present, numerous routine chromatographic and electrophoretic assays are used to characterize and monitor individual PQAs. However, execution of multiple routine methods for batch release, stability time-points, and process/formulation development support becomes time and resource intensive, and often provides an indirect measure of biologically relevant PQAs. Introduced in 2015, the multi-attribute method (MAM), based on LC-MS peptide mapping and automation principles, provides simultaneous and site-specific detection, identification, quantitation, and quality control (monitoring) of PQAs.   A dedicated Pfizer team has been regularly employing MAM on an in-house MAM platform to support biotherapeutic process and product development. In parallel, this team has continually explored and implemented improvements in the Pfizer MAM platform, including sample preparation and data processing automation, to move toward the next generation of MAM. Recently, a pre-commercial demo model of the new Orbitrap Exploris MX mass detector was evaluated in-house by the Pfizer MAM team. Here, the results of the evaluation and an assessment of the Orbitrap Exploris MX mass detector’s suitability as a next generation MAM instrument are presented.   Key Learning Objectives: Pfizer MAM platform milestones for characterization and routine monitoring Automation of sample handling and data processing and reporting Evaluation and optimization of the Orbitrap Exploris MX mass detector for MAM Who Should Attend: Laboratory managers Chromatographers New product developers Brought to you by:   Andrew W. Dawdy, Ph.D. Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc. Ann Thayer Contributing Editor, C&EN Media Group
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