Richard Moseley, Chief Technologist at Microsaic talks to Biopharma International about process analytical technology (PAT) for monitoring and controlling biopharma production processes.
When FDA’s process analytical technology (PAT) initiative was first unveiled, the aim was to have the industry move away from a mindset of “testing quality” at the end of production to instead develop methods that monitor, assess, predict, and control quality from the start of the manufacturing process. PAT tools have facilitated ongoing monitoring and adjustment of bioprocesses to ensure that biologic drug products are produced with high quality, meeting the required specifications all the time.
Founded in 2001, Microsaic Systems plc (LON:MSYS) is a high technology company which develops point-of-need mass spectrometers, designed to improve the efficiency of chemical and biological workflows.