228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

Continuing the ICH Q series with ICH Q5. This episode explains why Q5 exists, how to read it, and what it means for combination products. Q5 addresses quality challenges unique to biologics made in living systems where products cannot be fully characterized by physical and chemical testing alone and show inherent variability. It harmonizes expectations for viral safety, cell substrate controls including master and working cell banks, stability, and comparability after manufacturing changes. For combination products, Q5 mainly applies to the biologic drug constituent through stability and change impact rather than device requirements.

00:00 Intro to ICH Q5

00:25 Meet the Host

00:32 Why Biologics Need Q5

00:56 Key Risks Explained

02:11 What Q5 Covers

02:40 Scope and Structure

03:19 Q5 A to E Breakdown

04:19 How to Read Q5

05:05 Q5 for Combination Products

05:59 Wrap Up and Next Episode

Subhi Saadeh is the Founder and Principal at Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.