Scaling Cell Therapies: Ricardo Baptista on What Goes Wrong First

Scaling Cell Therapies: Where Science Meets Manufacturing Reality 

Drawing on his experience across Cellectis, CGT Catapult, and now SmartCella, Ricardo Baptista highlights that one of the first things to break when scaling a cell therapy is the maintenance of cell identity and genomic integrity, which becomes increasingly difficult as processes move from controlled lab settings to larger-scale manufacturing. He notes that a major misconception among scientists transitioning from preclinical development to clinical and manufacturing readiness is the assumption that their processes are already suitable for pivotal safety, toxicology studies, and GMP production. In reality, many teams underestimate the readiness of starting materials for GMP manufacturing and lack awareness around the need for assay qualification and validation for release testing. 

Baptista emphasizes that companies should begin thinking seriously about CMC and manufacturability as early as possible in R&D, yet many delay this, leading to costly setbacks later. To make cell therapies broadly accessible rather than niche treatments, he argues that organizations must take a more integrated approach: conducting health economics and market analyses early, designing manufacturing processes using technologies that can meet commercial demand, and building realistic cost-of-goods models that include full GMP operational requirements, such as staffing and environmental monitoring. Ultimately, he stresses the importance of defining a clear quality target product profile early on to guide development toward scalable and commercially viable therapies.

Why Ricardo’s Session Matters 

As the cell and gene therapy field moves beyond early clinical successes, the industry is facing a critical inflection point: the transition from promising science to scalable, commercially viable therapies. This session addresses the often-overlooked realities that determine whether a therapy can move from the lab to patients at scale.

Ricardo Baptista brings a rare, cross-functional perspective from organizations at the forefront of CGT development, highlighting where companies most often fail: not in the science itself, but in process readiness, manufacturability, and quality strategy. Attendees will gain practical insights into the hidden challenges of scaling, including maintaining cell integrity, preparing for GMP manufacturing, and avoiding costly delays caused by late-stage CMC considerations.

For anyone working in advanced therapies, this session underscores a crucial shift: success in CGT is no longer just about innovation, but about designing therapies with scalability, regulatory readiness, and market access in mind from day one.