Scaling Gene Therapy Production: From Bench to Clinic

In the latest issue of Lab Manager, our Senior GMP Compliance Consultant and Qualified Person, Drew Hope offers strategic and practical insights on one of the most critical transitions in cell and gene therapy: moving from early research into GMP-compliant clinical manufacturing.

Drawing on decades of experience across the CGT development lifecycle, Drew shares expert guidance on how to set therapies up for success from the start. His advice is particularly valuable for teams navigating the complex shift from academic or lab-based R&D to clinical-grade production, where regulatory, operational and technical requirements must be aligned from day one.

“Choose a true partner that you can work with—one who will implement a process that works well for your product,”

Drew Hope

Senior GMP Compliance Consultant and QP

Key takeaways from the article include:

• Design your facility around your process, not the other way around.
• Engage with regulators early to align expectations on quality and study design.
• Source GMP-compatible suppliers and materials from the outset.
• Embed a culture of training across your team – GMP compliance is everyone’s responsibility, not just the QP’s.
• Leverage phased automation and CDMO partnerships to balance cost, flexibility, and speed.

These lessons reflect our integrated approach – combining strategic consultancy with GMP manufacturing expertise to de-risk development and accelerate progress to clinic.

Read the full article on Lab Manager: Scaling Gene Therapy Production from Bench to Clinic