ArticlesDownstream January 27, 2014 Determining Criticality, Part Two: DoE and Data-Driven Criticality A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental... admin-element
ArticlesBioPharmaRegulatory December 29, 2013 Quality by design for biotechnology products—part 1 Quality by Design (QbD) is a concept applied to the design and development... admin-element
Articles October 4, 2013 Essentials in Establishing and Using Design Space Design-space generation always begins with CQAs, risk assessments, definition of materials... admin-element
ArticlesBioPharmaDownstreamUpstream August 5, 2013 QbD and PAT in Upstream and Downstream Processing To gain perspective on the implementation of quality by design (QbD) and process analytical... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream July 5, 2013 Addressing the Challenges in Downstream Processing Today and Tomorrow In recent years, most pharmaceutical companies have focused on the development of... admin-element
Articles June 22, 2013 Quality by Design: A CMO’s Perspective on Gaining Knowledge Faster and Better From a CMO perspective, the traditional strategy behind process development has largely been to... admin-element