11.17.20 -- Process Characterization: Ready For The FDA?
Gain Practical Insights From Our Actual Process Run
Watch our connected perfusion project and follow our step-by-step journey from N-1 to final product as we discuss our weekly progress. Hear valuable tips from our upstream and downstream scientists in our digital series Connecting the Dots.
White Paper |
By Monica M. Commerford, Ph.D.,Thermo Fisher Scientific
The curing potential of cell and gene therapies is driving the industry’s passion and motivation to gain a better understanding of the evolving regulatory guidelines for these products, in order to bring them to market faster.
Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.
Application Note |
By Cameron Kadleck, Jimmy Beaty, and Matthew Ferguson, Ph.D.,Lonza - API
Spray drying and jet milling are commercially viable engineering processes for the development of respirable drug products. This article presents a case study that explores the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol. Read our article to learn more.