ArticlesBioPharmaDownstreamRegulatoryUpstream July 2, 2019 Addressing the Complex Nature of Downstream Processing with QbD Regulators have been encouraging bio/pharmaceutical companies to incorporate the concept of... admin-element
ArticlesBioPharma April 19, 2017 Critical Quality Attributes Challenge Biologics Development Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an... admin-element
ArticlesBioPharmaRegulatory July 18, 2014 Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products A critical quality attribute (CQA) has been defined as “a physical, chemical, biological... 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