We review studies that involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step, and measuring the remaining virus.
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).
Analyze the cost distribution over time for autologous CAR T therapy manufacturing using process economics and insights from scientists and R&D. Discover how cell therapy manufacturers can combat these costs.
We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.