David Estapé, PhD

Senior Fellow - Biopharmaceutical Process

Basel, Switzerland

David is a recognized biotechnology thought leader. Throughout his career, he has led or supported design and provided GMP consulting services for clients within the biotech, vaccine and blood plasma pharmaceutical industries. With a strong interest in new technologies and regulatory trends, he participates heavily in organizations like BioPhorum and the International Society for Pharmaceutical Engineering.  

David’s primary area of focus as a technology manager for biotechnology clients is to provide all regions of the world with value-add insights and experience for front-end engineering process technologies, regulatory/Good Manufacturing Practice, advanced facility design and strategic planning.  

Insights By David

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GMP guidelines for ATMP manufacturing: A practical guide to risk-based compliance

What are the most relevant GMP guidelines and regulations for ATMPs? A practical guide to risk-based compliance.

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Operational Improvement

Operational improvement as the gateway to efficient ATMP production

Even a minor operational improvement can generate major benefits for ATMP manufacturers, particularly when personalized therapies are involved. Unlock these benefits in your own facility by using the tools of operational improvement to answer six mission-critical questions.

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How the automation pyramid enables commercial-scale ATMP manufacturing

Use the automation pyramid as a roadmap to navigate the transition from lab-scale ATMP manufacturing to a cGMP facility that’s compliant, optimized, and future-ready.

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Commercial Scale ATMP Manufacturing

6 questions to ask before transitioning to commercial-scale ATMP manufacturing

To move advanced therapy medicinal products (ATMPs) from the lab to the commercial-scale manufacturing facility, you need a future-proof plan. These 6 questions will help you create one.

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