ArticlesDownstreamRegulatoryUpstream July 15, 2021 Assessing Manufacturing Process Robustness The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by... admin-element
ArticlesDownstreamUpstream January 30, 2020 Mapping a Route for Cell and Gene Therapy Process Development The regenerative medicine field is still quite young, and companies developing commercial processes... admin-element
ArticlesDownstream April 11, 2019 New HiScale™ 10/40 for Scale-Down Studies Cytiva is pleased to announced the new HiScale™ 10/40. HiScale 10/40 column is especially suitable... admin-element
ArticlesBioPharmaRegulatory April 12, 2018 Understanding Validation and Technical Transfer, Part I Many new biological entities use unique processing flows and steps that can require non-traditional... admin-element
Articles March 15, 2014 Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle With the most recent FDA (1) and Inter-national Conference on Har-monization (ICH) guidances... admin-element