ArticlesRegulatory September 6, 2017 Avoiding Investigational Failures and Discrepancies Investigations-focused regulatory standards that apply to life-sciences organizations, such as... admin-element
ArticlesBioPharmaRegulatory June 28, 2017 N-Glycan Analysis of Biotherapeutic Proteins This article summarizes the approaches, challenges, and future perspectives for the characterization... admin-element
ArticlesDownstreamRegulatoryUpstream June 14, 2017 Managing Residual Impurities During Downstream Processing Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures. admin-element
ArticlesBioPharmaDownstreamRegulatory May 4, 2017 Being Thorough When Transferring Technology Tech transfer and scale up of biologics can be as complicated as biologic therapies themselves. admin-element
ArticlesDownstreamRegulatoryUpstream April 19, 2017 Downstream Processing for Cell-Based Therapies With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream April 5, 2017 Single-use Bioreactors Have Reached the Big Time Single-use bioreactors available from various vendors today are robust and provide the high-performance... admin-element
ArticlesDownstreamRegulatoryUpstream November 10, 2016 Improving Process-Scale Chromatography Chromatography is a crucial step in the purification of biopharmaceuticals and accounts for a... admin-element
ArticlesRegulatory October 10, 2016 Establishing Acceptance Criteria for Analytical Methods To control the consistency and quality of pharmaceutical products, analytical methods must be... admin-element
ArticlesBioPharmaRegulatory August 31, 2016 Perfusion in the 21st Century Cell-culture technology for biopharmaceutical manufacturing has steadily advanced over the past three... admin-element
ArticlesBioPharmaRegulatory August 16, 2016 Design and Qualification of Single-Use Systems Single-use technologies (SUT) have made significant inroads in biopharmaceutical and vaccine... admin-element