ArticlesRegulatory August 25, 2023 A risk based approach to sterile filtration Drug quality cannot be assured only by finished-product testing. Process validation is required to... admin-element
ArticlesRegulatory June 2, 2022 e-Learning: what is quality by design (QbD)? This free interactive course shares what quality by design (QbD) is all about. The focus… admin-element
ArticlesBioPharmaRegulatory October 29, 2014 Continued Process Verification for Biopharma Manufacturing Continued process verification (CPV) is the activity that provides ongoing verification of the... admin-element
ArticlesRegulatory October 17, 2014 Using Quality by Design to Develop Robust Chromatographic Methods The quality-by-design principles that enable a manufacturer to limit and control the sources of process… admin-element
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
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