Hardware Podcasts

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

Let's Combinate · 17 Dec 2025 · 9m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Let's Combinate BioWorks
Tools
PAT
Also
ICH Q13, RTD, ICH Q8, ICH Q9, ICH Q10, ICH Q11, ICH Q12

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