QbD Success and Challenges: ONDQA Implementation
Dr. Christine Moore shared her perspectives on the current status of QbD. The talk was titled: ONDQA Implementation, QBD: the success and remaining challenges. I am sharing my raw notes from her talk. Again, I will edit the article further after I return from my trip. I encourage you...
QbD Updates from ISPE 2013 (Washington, DC) Conference
I will be attending ISPE 2013 (Nov. 3-6) starting this Sunday. Although I won’t be presenting this time, I will share with the QbDWorks Community, Quality-by-Design related updates from the conference. Some key players of QbD in Biotech are attending: Janet Woodcock (Director of CDER, FDA ) Steven Kozlowski (Director,...
5 Challenges of Implementing QbD in Biologics: Opportunity?
As of October 2013, not one biologic product (large molecules) has succeeded with a full Quality-by-Design (QbD) regulatory filing. Compared to the success of small molecules, what are the specific challenges for Biologics or BioPharmaceuticals? Based on interviews from the industry, below is a summary of the challenges biologics...
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...
Cost of Developing Drugs: Why is it so High?
How much does it cost to develop a new drug? The answer, of course, depends on which product and which company we are dealing with. However, a Forbes journalist, Herper (2013) attempted to answer this question at a high level based on a study done by Dimasi (2003). As with...