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...

Dr. Janet Woodcock is the director of CDER, FDA and oversees 4000 people and 10000 drugs. At ISPE 2013, Dr. Woodcock began with the statement –“Industry QbD adoption was successful. but QbD submissions were a mixed success. Culture of quality is not there yet.” She also openly talked about...

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,...

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...

A Scientific Method for Experimentation How to Approach Design of Experiments in a Practical Way. [leadplayer_vid id=”52594F7A0148B”] Lots more to come. Subscribe.   SLIDE:  A Scientific Method Model for Experimentation So here is the scientific method model for experimentation.  It’s a little bit messy graph, but I hope you...

A Brief History of Design of Experiments – DOE. [leadplayer_vid id=”52594A4A370DB”] Please Subscribe to receive further Tutorials. There’s lots more to come. SLIDE:  The Scientific Method and the History of Experimentation (Aristotle, OFAT, Fisher, Box and Taguchi)   Let’s talk a little about the history of DOE.  We like...

I’ll begin posting Tutorials on Design of Experiments. This is different from the typical design of experiments training. Intro to Design of Experiments Part 1 Please leave comments on how these tutorials can be of more value to you. [leadplayer_vid id=”5257FE28D911C”]   Lots more to come. Subscribe for more.  ...

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...

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...