Articles April 8, 2021 Perfusion N-1 – A Way to Improve the Fed-Batch Production Process In this article, we show how the conventional N-1 seed train step was replaced by… 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
Articles March 25, 2021 mRNA Therapeutics and Vaccines – Key Process Considerations Learn more on key considerations and strategies for process development and scaling up in our... 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
ArticlesBioPharmaDownstreamRegulatory December 17, 2020 Virus-like Particles as Therapeutic Moieties of the Future Virus-like particles (VLPs) are viral capsid shells assembled without encapsulated nucleic acid. admin-element
ArticlesDownstream November 19, 2020 Developing a Continuous Large-Scale Perfusion Cell Culture Process Perfusion processes enable continuous operation over extended periods of time by constantly providing... admin-element
ArticlesDownstreamRegulatoryUpstream November 5, 2020 Reimagining Affordable Biosimilars Drug development is undergoing a transformation from multi-billion-dollar blockbusters to personalized... admin-element
Articles October 22, 2020 ISPE Releases Cleaning Validation Guide ISPE has released new guidance on the cleaning validation lifecycle, written by a group of… admin-element