ArticlesBioPharmaRegulatory June 28, 2017 N-Glycan Analysis of Biotherapeutic Proteins This article summarizes the approaches, challenges, and future perspectives for the characterization... admin-element
ArticlesDownstreamRegulatoryUpstream June 14, 2017 Managing Residual Impurities During Downstream Processing Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream April 5, 2017 Single-use Bioreactors Have Reached the Big Time Single-use bioreactors available from various vendors today are robust and provide the high-performance... admin-element
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
Articles November 10, 2016 Development of column packing methods based on pressure flow measurements Scale-up of a chromatography process might appear as simply increasing the column diameter to accommodate… admin-element
ArticlesRegulatory October 10, 2016 Establishing Acceptance Criteria for Analytical Methods To control the consistency and quality of pharmaceutical products, analytical methods must be... admin-element
Articles September 29, 2016 Modeling Bioreactor Performance Bioreactor design, including the geometry of the tank and impeller and the locations of inlets... admin-element
ArticlesDownstreamUpstream September 14, 2016 Process Chromatography Selection for Downstream Processing Applications Industry experts discuss best practices for selecting a separation technology. Process chromatography... 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
ArticlesDownstreamRegulatoryUpstream May 25, 2016 An Integrated Approach to Ensure the Viral Safety of Biotherapeutics Use of continuous cell lines in the manufacture of biological therapeutic products, such as... admin-element