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

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-12-17
- Length: 9m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-17-218-ich-q13-continuous-manufacturing-explained-batch-vs-continuous
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/218---ICH-Q13-Continuous-Manufacturing-EXPLAINED-Batch-vs--Continuous-e3cfmkv

## Summary

Subhi Saadeh, founder of Let's Combinate BioWorks, explains ICH Q13 guidelines for continuous manufacturing in drug-device combination products. He contrasts continuous flow with traditional batch processing, highlighting benefits like reduced time and waste, while noting high upfront investment and technical complexity. Key quality concepts discussed include Residence Time Distribution (RTD), real-time control strategies using Process Analytical Technology (PAT), and managing disturbances. Saadeh also outlines how validation, release, and lifecycle management differ under continuous operations, relying on real-time data rather than fixed batch endpoints.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-17-218-ich-q13-continuous-manufacturing-explained-batch-vs-continuous#t=0) Introduction: Subhi Saadeh and Let's Combinate BioWorks
- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-12-17-218-ich-q13-continuous-manufacturing-explained-batch-vs-continuous#t=0) Batch vs. Continuous Manufacturing Definitions

## Topics

- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)

## Most relevant to

early-stage companies

## Mentioned

- ICH Q13 (other)
- Let's Combinate BioWorks (company)
- PAT (tool)
- RTD (other)
- ICH Q8 (other)
- ICH Q9 (other)
- ICH Q10 (other)
- ICH Q11 (other)
- ICH Q12 (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)
- [Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-21-similarities-differences-between-in-vitro-diagnostic-ivd-devices-medical-devices) (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)
- [Quality Management for IVD Devices vs Medical Devices](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-04-05-quality-management-for-ivd-devices-vs-medical-devices) (Global Medical Device Podcast)
- [What are the Opportunities for Improvement (OFI) for Quality?](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2022-02-23-what-are-the-opportunities-for-improvement-ofi-for-quality) (Global Medical Device Podcast)

## Citing this page

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