One of the objectives of the upcoming ICH 12: Pharmaceutical Lifecycle Management guidance is to manage product development and manufacturing process information in order to establish and maintain appropriate change control over the entire product lifecycle. The 2014 ICH Q12 Concept Paper also stresses ICH Q12’s role in connecting ICH Q8 through ICH Q11 into a complete lifecycle approach to assure product quality and continuous improvement of manufacturing operations. However, neither the Concept Paper or subsequent public discussion and presentations appear to identify the ICH Q8 design space as a central mechanism for collecting and maintaining product and process information…
JUST PUBLISHED: "Standardized and GMP-Ready, Closed-System Processing of Expanded Adipose-Derived Stem Cells Using the Gibco CTS
Rotea System Across 2D and 3D Bioreactor Expansions." Click on the OPEN ACCESS ARTICLES tab below.