ArticlesDownstreamRegulatoryUpstream November 1, 2014 Viral Clearance Challenges in Bioprocessing Removal and inactivation of adventitious and endogenous viruses have traditionally been achieved... 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
ArticlesBioPharmaDownstreamUpstream September 1, 2014 Challenges of Protein Aggregation During Purification Removal of protein aggregates from biologic APIs is crucial due to their potential to increase... admin-element
ArticlesDownstream July 17, 2014 Analyzing Proteins Using SEC, MALS, and UHPLC Light scattering analysis combined with more rapid size exclusion chromatography improves protein... admin-element
ArticlesDownstream January 27, 2014 Determining Criticality, Part Two: DoE and Data-Driven Criticality A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental... admin-element
ArticlesDownstreamRegulatoryUpstream January 13, 2014 PDA’s Technical Report for Biotech Cleaning Validation Cleaning validation plays an important role in reducing the possibility of product contamination... admin-element
ArticlesDownstream November 22, 2013 Evolution of the Monoclonal Antibody Purification Platform BioPharm InternationalBy: Anurag S. Rathore, Ranga Godavarti, Vijesh Kumar, Nihal Tugcu for BioPharm International The… Derek Author Smith
ArticlesBioPharmaDownstreamUpstream August 5, 2013 QbD and PAT in Upstream and Downstream Processing To gain perspective on the implementation of quality by design (QbD) and process analytical... admin-element
ArticlesBioPharmaDownstreamRegulatoryUpstream July 5, 2013 Addressing the Challenges in Downstream Processing Today and Tomorrow In recent years, most pharmaceutical companies have focused on the development of... admin-element
BioPharmaBioPharmaBioPharmaBioPharmaDownstreamDownstreamDownstreamDownstreamRegulatoryRegulatoryRegulatoryRegulatoryUpstreamUpstreamUpstreamUpstream June 24, 2000 Placeholder admin-element