ArticlesBioPharma February 23, 2017 Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions... admin-element
ArticlesBioPharmaRegulatory August 31, 2016 Perfusion in the 21st Century Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three... admin-element
ArticlesBioPharmaUpstream February 18, 2016 Antibody Production in Microbial Hosts The biopharmaceutical industry is growing exponentially, driven by an ever-increasing demand for monoclonal antibodies (mAbs)… admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream November 19, 2015 Selecting the Right Viral Clearance Technology The introduction of adventitious viral agents is a recognized, inherent risk of biologic drug... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream September 10, 2015 Best Practices in Qualification of Single-Use Systems Single-use technology has been around for approximately two decades if disposable capsule filters... admin-element
ArticlesBioPharma August 13, 2015 Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification An important area of focus for the biopharma industry is the elucidation and development of... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream April 8, 2015 Continuous Manufacturing: A Changing Processing Paradigm Although continuous manufacturing is well established for bulk chemicals, complex automation and... admin-element
ArticlesBioPharmaRegulatory October 1, 2014 Challenges and Trends in Biopharma Facility Design Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers... 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
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