ArticlesBioPharmaBioPharmaQ&ARegulatoryRegulatory July 15, 2015 Risk Assessment and Mitigation in Biopharmaceutical Manufacturing BioPharm International spoke with Stephan Krause, director of quality assurance, Laura Jeannel... admin-element
ArticlesBioPharmaRegulatory July 15, 2015 Robust Optimization, Simulation, and Effective Design Space Developing product knowledge and process understanding is at the heart of modern drug... admin-element
ArticlesBioPharmaDownstreamRegulatory May 1, 2015 Modular Manufacturing Platforms for Biologics It should come as no surprise that the good design principles governing pharmaceutical manufacturing… admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream April 8, 2015 Continuous Manufacturing: A Changing Processing Paradigm Although continuous manufacturing is well established for bulk chemicals, complex automation and... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream April 6, 2015 Use of Multivariate Data Analysis in Bioprocessing The ever increasing demand of biotherapeutics, together with the pressure to contain healthcare... admin-element
ArticlesBioPharmaRegulatory March 26, 2015 Detecting Protein Aggregates and Evaluating their Immunogenicity Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. admin-element
ArticlesBioPharmaUpstream February 26, 2015 Quality by Design and Extractable and Leachable Testing Biopharmaceutical packaging performs several vital functions in assuring the drug product safety. admin-element
ArticlesBioPharma January 29, 2015 Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers This article discusses efforts to limit polymer degradation without significantly impeding cell growth. admin-element
ArticlesBioPharmaRegulatory October 29, 2014 Continued Process Verification for Biopharma Manufacturing Continued process verification (CPV) is the activity that provides ongoing verification of the... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream October 29, 2014 Application of Quality by Design to Viral Safety The biotech industry has begun to implement a quality-by-design (QbD) approach to ensure the... admin-element