218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)

In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means.

He compares batch vs. continuous, explains how a batch still exists in continuous manufacturing, and covers the essentials quality teams care about: RTD/traceability, control strategy, and disturbances/diversion plus a quick high-level note on validation, release, and lifecycle.

Timestamps

00:00 Intro

01:00 Batch vs. continuous (and batch definition)

03:00 Modes of continuous manufacturing (ICH Q13 examples)

04:30 RTD & traceability

06:00 Control strategy

07:30 Disturbances & diversion

09:00 Validation / release / lifecycle (high level)

10:00 Wrap-up

Subhi Saadeh is the Founder and Principal of Let’s Combinate BioWorks and host of the Let’s Combinate: Drugs + Devices podcast/Youtube Channel. With experience across Quality, Manufacturing Commercialization, Sustaining and R&D, Subhi has helped industrialize and launch drug delivery systems for biologics, vaccines, and generics at leading organizations such as Pfizer, Gilead, and Baxter. Subhi focuses on bridging the disconnect between drug and device development and specializes in harmonizing internal systems, aligning internal and external partners, and helping combination product teams move from siloed execution to scalable, compliant, and patient-ready solutions. He currently chairs the Rx-360 Combination Product Working Group and was the International WG Chair at the Combination Product Coalition. He has contributed to global harmonization efforts through BIO, ASTM, and AAMI. He is a certified ISO13485 Lead Auditor, CQA and CQE.

For questions, inquiries, or suggestions, please reach out at letscombinate.com or on the show’s LinkedIn Page.