Navigating the Challenges of Instrument Development in Cell Therapy Manufacturing : 35

MedTech Speed to Data

Cell therapy research and manufacturing are driving demand for automated high-throughput equipment to improve quality, reduce costs, and shorten the development cycles of innovative treatments that save lives. But what factors shape a startup’s journey from the lab to commercialization?

In Episode #35 of the Speed to Data podcast, Key Tech Business Development Manager Kelly Parker leads a panel of industry experts who discuss high-throughput automation in cell therapy screening and manufacturing.

Daniela Hristova-Neeley, Ph.D., is a partner at the advisory firm Health Advances, where she is a leader in the diagnostics and life sciences tools practice.

Blair Morad is Senior Director of Engineering at Cellino, a startup developing autonomous biomanufacturing technology for personalized cell therapies.

Nova Syed is a founder and angel investor in the deep tech and healthcare sector. Most recently, Syed was the founding VP of Product at Mekonos, a developer of silicon nano-needles for cell therapies.

Need to know

Three factors drive requirements in cell therapy screening:

· Customers are studying a huge variety of biological systems and drug targets.

· Business requirements drive the need for faster and cheaper therapy development.

· Meeting regulatory standards demands high-quality, reproducible data.

In manufacturing, meeting GMP makes design requirements even more complex as the product must:

· Improve flexibility and scalability.

· Improve quality control and traceability.

· Lower manufacturing costs.

· Reduce human interaction to improve efficiency and quality.

The nitty-gritty

Given the many competing business, market, and regulatory requirements, the instrument design process inevitably forces developers to make tradeoffs.

The panelists agreed that quality is table stakes, which means technologists and business leaders must balance time, cost, and scope.

“You have to be ruthless when it comes to prioritizing your differentiator,” Hristova-Neeley said.

In Morad’s experience, understanding the organization’s core competency is essential to focusing on the right problems.

Data that made the difference

The three panelists shared their lessons learned from hard experience in the healthcare technology business.

Get early feedback from the market. “Product-market fit doesn’t just happen,” Syed explains. “Unless you get feedback directly from the users and the customers, you don’t have the data to iterate to the next cycle.”

Hristova-Neeley agreed. “It’s always important to hear what the customers have to say. Automation is certainly important, but it’s not the only thing that is going to solve how we do cell therapy manufacturing or cell therapy development.”

Look for outside expertise. “When you’re working with the right experts,” Morad said, “they know how to ask the right questions that are helpful to move forward.” A good startup employs many intelligent people, but they won’t know everything about everything. Find outside partners who have already built the assays, workflows, automation modules, and other elements outside your core competency so you can focus on your innovations.