ArticlesDownstreamRegulatoryUpstream July 15, 2021 Assessing Manufacturing Process Robustness The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream June 17, 2021 Innovative Chromatography Resins Can Improve Purity and Quality With ongoing efforts to increase monoclonal antibody (mAb) productivity in large-scale biomanufacturing... admin-element
ArticlesDownstreamRegulatoryUpstream March 25, 2021 Basics in Process Development for Biotherapeutics Definitions, activities, and things to consider when developing an upstream or downstream bioprocess. admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream February 25, 2021 Remote Monitoring and Big Data Advance Upstream Automation As upstream processing drives toward higher efficiencies in meeting demand, it requires optimizing... admin-element
ArticlesUpstream January 28, 2021 Developing a Closed, Connected Single-Use mAb Purification Process Learn more on this case study to set up a closed and connected single-use monoclonal… admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream January 14, 2021 Updating Viral Clearance for New Biologic Modalities Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities. admin-element
ArticlesDownstreamRegulatoryUpstream November 5, 2020 Reimagining Affordable Biosimilars Drug development is undergoing a transformation from multi-billion-dollar blockbusters to personalized... admin-element
ArticlesDownstreamUpstream July 30, 2020 Lentiviral Vector Upstream Process in Single-use Bioreactors Lentiviruses exhibit many desirable properties as gene transfer vehicles, such as high transduction... admin-element
ArticlesDownstreamRegulatoryUpstream July 16, 2020 Eliminating Residual Impurities Starts with a Strategic Plan Residual impurity testing is essential to ensure the quality and safety of pharmaceutical products... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream June 4, 2020 Biomanufacturing: Demand for Continuous Bioprocessing Increasing In nearly all other manufacturing technologies, cost considerations dictate that... admin-element