Ask Questions: Upcoming Interview with Anurag Rathore
Submit your burning QbD or PAT questions! This week, I am thrilled to interview Dr. Anurag Rathore, the co-author of Quality by Design for Biopharmaceuticals: Principles and Case Studies. We’ll talk about Anurag’s personal journey and his book in QbD.
Dr. Anurag S. Rathore is currently a professor at Department of Chemical Engineering, IIT Delhi. Anurag obtained his Ph.D. from Yale University and then worked in the Process Development groups at Pharmacia (now Pfizer) and Amgen before joining the Department of Chemical Engineering, IIT Delhi in 2009. He is an active member of the Parenteral Drug Association (PDA) and American Chemical Society (ACS) and have authored more than 200 publications and presentations in these areas. He serves as the Editor-in-Chief of Preparative Biochemistry and Biotechnology and participate in the Editorial Advisory Boards for several international journals including PDA Journal of Pharmaceutical Science and Technology,Biotechnology Progress, BioPharm International, Pharmaceutical Technology Europe and Separation and Purification Reviews. He also serves as a member of the Biotechnology Advisory Board of PDA and the Scientific and Education Advisory Council of the National Institute for Pharmaceutical Technology and Education (NIPTE).
Ask Questions!
in the comments section below or email me (through the contact form) by Thursday (May 1st, 5 AM. California Time) and we’ll be able to address some of your questions during our interview. I am very excited about this interview!
QbD is being projected as a panecea for all things. if so, why its absorption remained a virtual challenge?
Great question! I’ll let Anurag take this one first.
From Mehtap Saydam of Sanovel
I am looking into A-MAB case study. There is a screening design in Filling step (page 210). I couldnt define what kind of optimal design it is. One more point that confused me, on the following page (page 211), a Design space graphic is presented. I think it is only a representative graphic for factors, without any response optimisation datas, not related with statistical DoE. Because in the end of the study, they are giving the design space with a Processing parameters table (Table 5.26, page 215), which looks more suitable for this graphical representation. Have you ever examined this document before? I wonder your opinions about the Design Space terminology for this part of the study, and also DoE type. And I have a little more detailed question, what kind of software can be used to visualise just kind of graphics other than MATLAB?
-From Mehtap Saydam of Sanovel
I can take this one since it’s technical. It’s a mixed level DOE design. The A-Mab case study has 2 factors with 2 levels (Temperature, Nozzle ID size) and 2 factors with 3 levels (Nozzle position, pump speed). It used L18 Chakravarty screening design (18 runs). Given that it’s a screening, I would personally not recommend this DOE design.
Regarding software for DOE’s, I use JMP due to better visual graphs.
UPDATE: We’ve been talking but been cut off by Skype. We’ll finish the interview on Monday morning. Anurag, Thank you for your time and willingness to share with our community.