3 Reasons Why QbD projects get Stuck & What to Do about it
I have seen and experienced many QbD projects get stuck. There are 3 main pillars in Quality-by-Design: Risk assessment; Design Space; Process Analytical Technology. FIGURE: 3 Pillars of Quality-by-Design (QbD) Of the three, many companies seem to be focusing and spending much time on the Risk Assessment piece but not...
Why the 1st Biologics QbD submission Failed – Genentech (Roche) Perjeta
I recently read the EMA (European Medicines Agency) report on Genentech’s (Roche) attempt to file Perjeta (Pertuzumab) as a Quality–by–Design (QbD) submission. I was excited to see a Biologics product (monoclonal antibody) going through QbD for the first time. I tout their effort. Sadly, FDA rejected it as a...