Welcome to the 22nd episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends!
This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin has a depth of experience in pharmaceutical development and implementing methodologies founded in Quality by Design (QbD). He is a Chemical Engineer and got his PhD in Chemical Engineering from Rutgers University. He has been spending the past 12 years in the inhalation part of life sciences and pharmaceutical development. He has gotten involved in the area of QbD in the last 4-5 years to try and understand how they can better their development on their products at Experic, where he serves as Director of Pharmaceutical Development and Manufacturing Services.
Today they are going to be discussing Quality by Design — a really important and hot topic in pharmaceuticals! In the past decade, there has been rapid adoption of QbD on the pharmaceutical side of the life sciences industry. So tune in to learn all about what QbD is, what the overall process looks like, the phases and approach of a formalized QbD process from a pharmaceutical development perspective, the relationship between QbD and experimental design, how QbD can help design an effective product development plan, and much more.
[:14] About today’s episode.
[1:49] About today’s featured guest, Justin Lacombe.
[2:08] Justin introduces himself and gives some background about his career.
[4:05] Justin explains what QbD is and what the overall process looks like. He then goes a bit deeper, explaining the phases and approach of a formalized QbD process from a pharmaceutical development perspective.
[9:01] Justin explains the relationship between QbD and experimental design, and how this all ties into controlled strategy for manufacturing.
[15:18] Justin outlines how critical quality attributes and QbD can help design an effective product development plan.
[20:41] Why is QbD so critical for tech transfer?
[23:23] Mandy highlights the benefits of QbD.
[25:35] Thanks for listening to this week’s episode! If you have any questions for Mandy you can contact her at . If you have any questions for this week’s guest, Justin Lacombe, you can contact him on his LinkedIn page, linked below.
Mentioned in this Episode:
Justin Lacombe (LinkedIn)
Quality by Design (QbD)