How to Choose Which Design Space Studies to Work On – Why QbD Risk Assessment is Not Just a Risk Assessment
If you ask an average pharmaceutical scientist, “What is QbD?” she or he will mostly likely answer: DOE (Design of Experiments). As scientists, we are attracted to design space studies (including myself) because it is an extension of our daily work. However the bigger question is – “Which process...
QbD Design Space for Analytical Assay — Screening DOE [Tutorial]
I’m excited to share a Case Study on QbD Design Space for Analytical Assay — Screening DOE. Dr. HS Kim from Green Cross kindly shared his slides titled: “QbD using Design of Experiments Application for Analytical Assay.” The data of the experiment comes from Experimental Design in Biotechnology (Statistics: A Series...
Design Space in QbD — Definitions
If you are new to QbD, here are the basic definitions of “Design Space” in QbD. If you have to explain the terminologies to your colleagues, you can refer them to this page as a resource. I’m building a resource page (Start Here) for QbD newcomers. ICH Q8 (R2)...
1st QbD Approval for Biologics: Gazyva Design Space
“This will be the first OBP BLA* with an approved design space.” (CDER, *OBP: Office of Biotechology Products, BLA: Biologics License Applications). Quality-by-Design in Biologics is challenging. Skepticism prevails. (i.e. Matej Horvat’s excellent discussion). I outlined a few reasons why QbD in Biologics is challenging in an earlier article. Complexity and heterogeneity...
QbD in Biologics: Genentech’s Success and Failure in Design Space Approval
Earlier, I posted why the 1st Biologics failed in full QbD submission. Now Genentech has been redeemed and is pioneering Quality-by-Design in biologics / biotechnology / large molecule / biopharmaceuticals. Dr. Lynne Krummen of Genentech (Roche) kindly shared her experience with 2 products: Perjeta and Gazyva. Both were full-QbD...
Pharmaceutical Quality by Design Book – Practical or Theoretical? [Interview]
A new book on Quality by Design was recently published. When I read such a book on QbD, I ask – “is it merely theoretical or actually practical?” As a scientist who deals with the reality of messy biologics and constraints of time and resources at the office, I...
Why Not Use Design of Experiments for QbD?
Confession Today, I share an embarrassing story… I did not truly appreciate DOE. When I was teaching Six Sigma topics at Stanford University and Keio University, I only scratched the surface level. Main reason was that most project sponsors could not share their proprietary or confidential details (process parameters), hiding real numbers...
No Regulatory Incentives for Quality by Design (QbD)? 10 Recommendations
Are there any regulatory incentives for Quality by Design (QbD)? The Pharma Industry is disappointed about what FDA and ICH hinted as a benefit of QbD (Quality-by-Design) — Regulatory Flexibility. “While QbD concepts described in ICH Q8(R2) and Q11 are… well accepted by FDA and Pharma, recent regulatory experience...
QbD for Drug Device Combination Products – Part 2
This is the part 2 of the interview from Manfred on the drug device combination product. If you haven’t yet, please listen to the first part of QbD for Drug Device Combination Products. Today, we cover: Design Controls versus Quality by Design (QbD) – how is it different? When...
Minimum QbD, Enhanced QbD, and R&D QbD – How Are They Different?
I know what you are thinking. “We have no resources for implementing a full QbD. What is the minimum requirement to call our development process a QbD?” This article addresses that question. But it also provides a roadmap to enhance the “minimum QbD” over a period of time. Ildikó...