# 228 - ICH Q5 EXPLAINED: Why Regulators Treat Biologics Differently

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2026-03-04
- Length: 6m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-04-228-ich-q5-explained-why-regulators-treat-biologics-differently
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/228---ICH-Q5-EXPLAINED-Why-Regulators-Treat-Biologics-Differently-e3ftimn

## Summary

Subhi Saadeh, Founder of Let's Combinate, explains ICH Q5, the regulatory guideline for biological and biotechnological products derived from living systems. He details how Q5 addresses viral safety (Q5A), cell substrate controls (Q5D), stability (Q5C), and comparability after manufacturing changes (Q5E). Saadeh emphasizes that for combination products, Q5 applies specifically to the biologic drug constituent, focusing on stability and change impact rather than device requirements.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-04-228-ich-q5-explained-why-regulators-treat-biologics-differently#t=0) Introduction to ICH Q5 and Biological Products
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2026-03-04-228-ich-q5-explained-why-regulators-treat-biologics-differently#t=0) Why Biologics Need Q5: Risks and Variability

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q5 (other)
- Let's Combinate (other)
- Combination Products Coalition (other)
- ASTM Committee E55 (other)
- AAMI (other)

## Related episodes from other shows

- [#380: Navigating the Complex World of Combination Products with Subhi Saadeh](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-08-30-380-navigating-the-complex-world-of-combination-products-with-subhi-saadeh) (Global Medical Device Podcast)
- [#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-08-03-467-combination-product-compliance-pmoa-21-cfr-part-4-qms-alignment) (Global Medical Device Podcast)
- [#445: ISO 10993-1:2025: What Risk-Based Biocompatibility Means for MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2026-02-02-445-iso-10993-1-2025-what-risk-based-biocompatibility-means-for-medtech) (Global Medical Device Podcast)
- [#323 The Combination Products Handbook](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-06-16-323-the-combination-products-handbook) (Global Medical Device Podcast)

## Citing this page

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