ArticlesBioPharmaDownstream January 17, 2019 A Look at the Affinity Chromatography Landscape Affinity chromatography offers the high selectivity required for biopharmaceutical manufacturing and analysis. Specific binding... admin-element
ArticlesBioPharmaDownstreamUpstream July 2, 2018 Challenges in Cell Harvesting Prompt Enhancements Cell harvesting is a crucial step that can have significant impact on product quality and… admin-element
ArticlesBioPharmaRegulatory April 12, 2018 Understanding Validation and Technical Transfer, Part I Many new biological entities use unique processing flows and steps that can require non-traditional... admin-element
ArticlesBioPharmaRegulatory November 16, 2017 Evaluating Surface Cleanliness Using a Risk-Based Approach Regulated companies that use automated cleaning applications have always struggled with correlating... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream September 21, 2017 Bioburden Control in the Biopharmaceutical Industry The biopharmaceutical industry has witnessed tremendous breakthroughs during the past few years. However, this advancement... admin-element
ArticlesBioPharmaDownstream September 21, 2017 Impact of Media Components on CQAs of Monoclonal Antibodies Recombinant protein products have made a revolutionary impact on human healthcare by enabling mass... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream September 7, 2017 The Role of Quality Standards for Biomanufacturing Raw Materials Successful pharmaceutical manufacturing strategies depend on raw materials that are of good quality. admin-element
ArticlesBioPharmaDownstreamUpstream August 11, 2017 Process Chromatography: Continuous Optimization Cell-culture and fermentation are high-yielding processes that effectively produce... admin-element
ArticlesBioPharmaRegulatory June 28, 2017 N-Glycan Analysis of Biotherapeutic Proteins This article summarizes the approaches, challenges, and future perspectives for the characterization... 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