ArticlesRegulatory August 13, 2015 Cleaning of Dedicated Equipment: Why Validation is Needed Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and... admin-element
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
ArticlesDownstreamRegulatoryUpstream June 4, 2015 Host-Cell Protein Measurement and Control Host-cell proteins (HCPs) constitute a major part of process-related impurities during biologics... 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
ArticlesRegulatory April 8, 2015 USP Publishes Monoclonal Antibody Guidelines As FDA gears up towards approving biosimilar drugs in the United States, it is unquestionable... 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
ArticlesRegulatory November 12, 2014 Setting Standards for Biotech Therapeutics in India The past decade has seen considerable growth in the Indian pharmaceutical industry. India has... admin-element