Product and process-related impurities impact biopharmaceutical development at every stage from discovery to development to manufacturing. Detecting, identifying and characterizing these variants and impurities are of high regulatory concern, due to the potential correlation between aggregation and increased immunogenicity of the biotherapeutics.
Among the impurities, aggregates such as subvisible and submicron particles, and host cell proteins are of particular challenge. Responding to popular demand, CHI is pleased to bring you a new conference on Characterizing Aggregates & Impurities as part of the Biotherapeutics Analytical Summit, to bring together best practices and new insights in the identification, monitoring and characterization of these impurities and contaminants.
The Biotherapeutics Analytical Summit, with its hallmark brand of topics on Method Development, Qualification & Validation, Advances in Characterization Methods & Approaches and Comparability & Biosimilarity, and its signature mix of regulators, industry and academia speakers, has come to be known as THE Analytical Summit where attendees can hear and learn about real-life case studies, innovative concepts and practical approaches that can help scientists advance their molecules from discovery to development and commercialization.
Prediction, Detection and Characterization of Aggregates and Particulates