ArticlesBioPharmaDownstreamUpstream February 28, 2019 Bispecific Antibody Purification: Insights and Case Studies New modalities, like bispecific antibodies, present unique challenges compared to mAb production. admin-element
BioPharmaBioPharmaQ&ARegulatoryRegulatory February 14, 2019 Supply Chain Challenges for Single-Use Systems The implementation of single-use systems (SUS) for biopharmaceutical manufacturing as an alternative... admin-element
ArticlesBioPharmaDownstreamUpstream January 31, 2019 Modeling the Degradation of mAb Therapeutics Ensuring the stability of biotherapeutic products, which has an impact on their safety and... admin-element
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
ArticlesBioPharmaDownstreamRegulatory December 20, 2018 Achieving Process Balance with Perfusion Bioreactors Perfusion cell-culture processes have been used for more than two decades for the production of... admin-element
ArticlesBioPharmaDownstreamRegulatory September 27, 2018 Ensuring Viral Safety of Viral Vaccines and Vectors Vaccines, including viral vaccines, are a crucial invention in human history and continue to... 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
ArticlesBioPharmaDownstreamRegulatory June 7, 2018 Putting Viral Clearance Capabilities to the Test Drug products based on live cells have an inherent risk for viral contamination that could… 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 March 1, 2018 Efficient Cleaning-In-Place Methods for Protein-Based Antibody Affinity Chromatography Resins This whitepaper discusses cleaning of affinity resins for purifying monoclonal antibodies and Fab fragments… admin-element