Building the Digital Backbone for Scalable Cell Therapies: Key Insights from Cell and Gene on the Mesa 2025

by Marcia Blackmoore | posted on December 04, 2025

At this year’s Cell and Gene on the Mesa conference, I moderated a panel discussion on what it takes to build the digital infrastructure needed to accelerate delivery of cell therapies to patients. The conversation brought together three distinct perspectives from across the cell therapy ecosystem: Carolyn Lutzko, PhD, Scientific Director of the Cell Manipulation Core Facility at Dana-Farber Cancer Institute; Jason Bock, PhD, Co-Founder and CEO of CTMC; and Daniel Ramirez, VP of Operations and Site Head at Cellipont Bioservices.

Collectively, the panel represented the full spectrum of cell therapy manufacturing. Dana-Farber’s facility supports both academic research and GMP manufacturing across the Harvard hospital system. CTMC operates as a hybrid organization, pairing process development, manufacturing, analytics, regulatory support, and clinical execution under one roof. Cellipont Bioservices brings a CDMO perspective, supporting clients from early-phase programs through commercial readiness.

The Realization: Why Cell Therapy Manufacturing Requires New Thinking

When I asked the panel about the moment they realized transformation was necessary, Dr. Bock shared a story that resonated across the room. Coming from antibody development, where a typical BLA might require just six to nine batches across an entire clinical development program, he attended his first cell therapy conference after joining MD Anderson. 

“The very first talk was from Kite when they had just gotten their product approved,” Jason recalled. “It was actually a relatively small number of patients that they treated to get commercial approval, seventy-five or so. Well, that’s really interesting, but that meant seventy-five batches.”

The distinction goes beyond volume. “When he was talking about the short vein-to-vein time, he was literally [saying] the patients don’t have time and every day matters,” Jason explained. This urgency, combined with the need to manufacture individual batches rapidly and at scale, requires fundamentally different approaches than those used in traditional biologics manufacturing.

The Digital Infrastructure Challenge: Connecting What Already Exists

A consistent theme across the panel was that digital transformation is not only about installing new systems. It is about connecting the existing systems.

As Dr. Lutzko put it, “The challenge is connecting the dots between the disparate systems that are already in place.” In a high-throughput transplant center that also handles early phase manufacturing, fragmentation creates a significant operational and logistical burden. Managing chain of identity, chain of custody, sample routing, release testing, and inter-site communication becomes increasingly complex without digital support.

This fragmentation creates real operational problems. Adding the CDMO perspective, Mr. Ramirez described a scenario familiar to everyone in the room: “I’ve got calls on Thursday afternoon that you’re receiving a tissue tomorrow. And you have to move the world to make sure that you have the proper capacity, the proper resources allocated, the material solutions, etc,” he said.

Dr. Bock added context to why these last-minute scrambles happen: “Probably there were four calls before you got the call, this person, and this person. And each one of those layers adds a little bit of inefficiency, and you lose maybe three hours, maybe four hours.” The solution, he suggested, lies in making information flow more efficiently and instantaneously through digital connectivity, so everyone has access to real-time information.

The Vision: What Best in Class May Look Like in Three Years

Looking ahead, each panelist offered a distinct but complementary vision of what best-in-class cell therapy manufacturing will look like.

Dr. Lutzko emphasized integration: “The connecting of the dots between the disparate systems that are already in place, from chain of identity, chain of custody, inventory controls, set up into your manufacturing process, release process, and logistics. Sealing the junctions between each of these disparate activities.”

Dr. Bock focused on how people spend their time: “People focused on the value-adding activities and systems handling the important but non-value-adding activities. We’re coming up with new processes, we’re finding ways of improving things, and systems are taking care of a lot of the backend and making sure that we don’t make mistakes.”

Mr. Ramirez brought the conversation back to the ultimate goal: “I would love to see more companies adopting Pharma 4.0 concepts, being fully digitalized and automated. And more importantly, affordability for the patients. If we’re not able to deliver these drugs to patients, we are failing as an industry.” 

The Path Forward

The panel discussion reinforced that digital transformation in cell therapy manufacturing is no longer optional. It’s essential for scaling these life-saving therapies and making them accessible to more patients. The challenges are real, from implementation hurdles to the need for better system integration. But the vision is clear: an industry where digital infrastructure enables manufacturers to operate more efficiently, reduce errors, respond more quickly to patient needs, and ultimately lower costs.

For organizations embarking on or continuing their digitalization journey, the message from these three industry leaders converges on a simple message: focus on connecting systems, reduce implementation friction where possible, keep people focused on value-adding work, and never lose sight of the end goal: getting these transformative therapies to the patients who need them.

A full recording of the panel discussion is available below for anyone interested in a deeper dive into the conversation.