Sub-Visible Particle Assessment for High Concentration Biologics
Abstract: Particles and impurities can come from the products, any stage of bioprocessing or the packaging containers. The presence of particulates for high concentration drug product can impact the stability, safety and efficacy of the biomolecules and biologic products. Therefore, during the development of high concentration formulation, key challenges, tools and strategies to detect, characterize and carry out risk assessment of particles and sub visible particles will be discussed.
- Detection and Characterization of Particulates
- Tools and Strategies for Risk Assessment, Prediction and Characterization of Particles
About Our Speaker:
Indu Javeri is the President of CuriRx and former CEO of Formatech, Head of Manufacturing and Development Abbott Biotech, Associate Director Cambridge NeuroScience.