The promise of advanced cell therapies is undeniable, but as demand skyrockets, the challenges of taking a living drug from bench to bedside have never been greater. Each batch brings variability, each jurisdiction adds regulatory hurdles, and every strategic decision can determine whether a lifesaving therapy reaches patients or fizzles out behind clinical barriers.

Lindsay Davies is a leading figure in the cell and gene therapy field, serving as Vice President-Elect for Europe at the International Society of Cell and Gene Therapy (ISCT). She is Chief Scientific Officer at NextCell Pharma, co-founder of QVance, and founder of the consultancy CellTherEx. With over 20 years of experience across academia and industry, she brings deep expertise in MSC manufacturing, process development, and commercialization of advanced therapies. Here are three reasons this episode is a must-listen:

• Manufacturing at Scale, Without Compromise: Lindsay shares why NextCell Pharma has stuck with large-scale 2D manufacturing for MSCs, leveraging cell morphology and a patented donor selection algorithm to reduce batch-to-batch variability while maximizing reproducibility and safety, even when treating hundreds from a single batch.
• Smart Scaling: Up, Out, or Both? The debate isn’t just academic. Lindsay explores when it makes sense to scale up processes versus scaling out to multiple manufacturing sites. She highlights how harmonizing global regulatory expectations and moving to closed 2D systems can lower costs, de-risk production, and bring life-changing therapies to more patients worldwide.
• Network or Nowhere: Lindsay calls out the myth of the lone innovator, championing the crucial role of strategic networking, partnership models, including “sweat equity”, and early regulatory engagement as keys to avoiding the common commercialization pitfalls that stall so many promising ATMPs.

Wondering how to navigate the twin challenges of process control and commercial viability in ATMP development? This episode offers a rare, candid roadmap from the front lines.

Connect with Lindsay Davis:

LinkedIn: www.linkedin.com/in/lindsay-c-davies

Website: www.nextcellpharma.com

If you're interested in breakthroughs in cell therapy, here's what some of our previous guests have shared from the front lines of innovation:

• Episodes 105-106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer
• Episodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay
• Episodes 125-126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei

Next step:

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