FDA CDER’s Christine Moore, PhD, acting deputy director of the Office of New Drug Quality Assessment, explains how her office is leading the Agency in moving from conceptual QbD to actual implementation. Gary Ritchie interviews (with a cameo from Emil Ciurcak).
Methods of science-based calibration have come a long way in a few years. Gary Ritchie sits down with VTT Chief Science Officer Ralf Marbach to find out how.
Scale is a function of patient requirements and manufacturing productivity, says Amgen scientific executive director Duncan Lowe. Where QbD’s impact will be felt more is in facilitating equipment and knowledge transfer across sites. Gary Ritchie gets the Lowe-down in this IFPAC 2009 interview.
Process HPLC has come a long way, and Rick Cooley, formerly of Lilly and currently of Dionex, gives Emil Ciurczak a cook’s tour of the new Integral, whose modular functionalities make it suitable for the lab or process plant.