ArticlesBioPharmaRegulatory October 1, 2014 Challenges and Trends in Biopharma Facility Design Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers... admin-element
ArticlesRegulatory September 18, 2014 Evaluating Design Margin, Edge of Failure and Process A product’s or process’ design space is generally considered to be the area where process... admin-element
ArticlesBioPharmaRegulatory July 18, 2014 Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products A critical quality attribute (CQA) has been defined as “a physical, chemical, biological... admin-element
ArticlesBioPharmaRegulatory June 13, 2014 Challenges in Analytical Method Development and Validation The manufacture of biopharmaceuticals presents some unique challenges when ensuring... 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
ArticlesBioPharmaRegulatory December 29, 2013 Quality by design for biotechnology products—part 1 Quality by Design (QbD) is a concept applied to the design and development... 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