Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

211: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo - Part 1

Dec 2, 2025
In this engaging conversation, Jesús Zurdo, a biotech scientist with nearly 30 years of experience and a leukemia survivor, shares unique insights on merging innovation with patient access. He emphasizes the need for patient-centered product design right from the start and discusses the balance between urgency and safety in manufacturing. Jesús challenges the biotech industry’s focus on costs over access and advocates for quality that is fit-for-purpose. He also explores alternative pricing models and the importance of real-world patient outcomes in therapy development.
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INSIGHT

Scale Up Is About Patients, Not Volume

  • Scaling up means increasing the number of patients reached, not just liters or cell counts.
  • Consider patient access, location, and affordability when designing manufacturing strategies.
ADVICE

Prioritize Safety While Acting With Urgency

  • Do not equate patient urgency with cutting corners; maintain safety and manufacturing confidence.
  • Balance speed with robust processes so effective products can be scaled and safely delivered.
ANECDOTE

Rapid Point‑Of‑Care Cell Delivery

  • Jesús Zurdo received living donor cells at his bedside within 48 hours after an apheresis in the U.S.
  • Point-of-care stem cell logistics worked reliably across countries with limited infrastructure.
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