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Continued progress in the development of sensitive and high-resolution analytical technologies have enabled significant progress towards the goal of a Well Characterized Biological Product. These advances allow for detailed characterization of biotherapeutic modalities even as the structural complexity of these modalities increase. Additionally, rapid analytical methods with equivalent or better sensitivity and precision are replacing methodologies requiring longer lead-times, ensuring quicker patient access to lifesaving therapies.
This session will focus on the current state of the art technologies utilized for product release and characterization, and how these technologies have evolved over time to accommodate product characterization of complex modalities with increased structural resolution.
This session is a continuation of Wednesday’s Speed to Patient Plenary Session. This session includes talks on novel strategies for manufacturing and testing products. It will also include a session from the EMA to discuss opportunities to gain approval for these novel strategies…
“Alone we can do so little, together we can do so much” is a Helen Keller quote which captures the spirit of CASSS-organized conferences like WCBP, the regional CMC strategy forums, and technology specific meetings…
Use of animals and/or animal derived products to demonstrate safety or efficacy supports drug development and, in some cases, is required by law to release drug product…