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...
New Course: Lean & Agile DOE for QbD
I’d like to begin sharing my lessons learned with the community–a “practical” approach that I have been developing while working in the trenches of the Biotechnology industry. For now, I call it “Lean & Agile DOE for QbD.” As a researcher-for-life, I observed what worked and what did not....
Course Overview
I’d like to begin sharing my lessons learned with the community–a “practical” approach that I have been developing while working in the trenches of the Biotechnology industry. As a researcher-for-life, I observed what worked and what did not. After extracting the best practices that actually worked and taking out...
Training
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How To Apply QbD to Drug Device Combination Products
Today, we invite Dr. Manfred Maeder of Novartis to share how Quality-by-Design is applied in the development of medical devices and drug device combination products. Previously, Dr. Lana Shiu of FDA shared the ongoing regulatory changes in drug device combination products. I recommend you listen to her presentation as...
QbD for Dry Powder Inhalation Formulation (Combination Product)
Dr. Edina Pallagi is the QbD pioneer of Hungary. The University of Szeged team recently published, “New aspects of developing a dry powder inhalation formulation applying the quality-by-design approach” For a complimentary PDF access, download the QbD case study by Sept. 5 The one-sentence takeaway is: By...
What Experts Do: RPN for QbD Risk Assessment
Previously, we learned: To use a RPN scale commensurate at the level of information available. If you are in development stage, High-Med-Low is recommended. When discussing Control Strategy, separate the rankings of Severity and Occurrence. At the development stage, the main goal of Risk Assessment in Quality by Design...
FDA Regulations on Mobile Medical Apps
Are you aware of the FDA Regulations on Mobile Medical Apps? FDA recently issued the Mobile Medical Applications (MMA) Guidance for Industry and Food and Drug Administration staff on Sept 25, 2013. The document outlines the agency’s regulation of mobile medical apps as devices and their intent to focus only...