Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharma quality system with less need for oversight prior to implementation.
- Clinical trial sponsors and clinical supply vendors must fully consider all attributes of their supply chains to ensure continuity of supply post-Brexit. This whitepaper outlines many questions that sponsors and vendors alike should ask
Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
Erythrocytes have significant value in specific types of research. If your objective is biobanking these cells in an intact state then it is equally important that hemolysis and the need for a re-draw is avoided. This paper explains how hemolysis can be prevented during specimen collection and handling.