Cell and gene therapies take two steps forward, one step back

While cell and gene therapies are among the most promising medicines, they are complex to develop and manufacture. It’s a sobering reality that continues to challenge the sector with developers and contract development and manufacturing organizations (CDMOs) shuttering doors and downsizing workforces.

Charles River Laboratories said this week that it is closing a cell therapy CDMO site in Hanover, Maryland. In 2021, Charles River purchased the Hanover facility as part of its $875 million acquisition of Cognate BioServices, along with gene therapy CDMO providers Cobra Biologics and Vigene Biosciences. What changed in the ensuing five years?

Despite the potential of the “high growth” cell and gene therapy sector, Charles River has learned some harsh lessons about the business environment. Last month at the 2026 J.P. Morgan Healthcare Conference, CEO James Foster said the company has conducted a strategic review of its portfolio with the decision to divest some businesses that are underperforming to focus on more profitable growth opportunities.

Charles River joins other CDMOs such as Catalent, which is slated to close its cell therapy center in Belgium, who have recently decided to scale back cell and gene therapy facilities or completely exit the market due to overcapacity and weak demand.

At the same time, integrated development and manufacturing organization Cellares announced last week a $257 million Series D financing round — bringing its total capital raised to $612 million — with proceeds to be used for the buildout of automated “smart” factories in San Francisco, New Jersey, the Netherlands, and Japan.

“The barrier to curing more patients is no longer scientific — it is industrial,” according to Cellares CEO Fabian Gerlinghaus, who said his company’s goal is to industrialize global cell therapy manufacturing with automation. While conventional CDMOs need to build 10 facilities to achieve commercial-scale capacity, Cellares contends that it needs to build just one facility. 

Automation holds great promise for cell therapy manufacturing and other companies are leveraging the technology. Last week, AstraZeneca and Multiply Labs announced a collaboration to evaluate GMP-ready robotic systems for scalable, high-throughput cell therapy production.

Multiply Labs claims robotic arms operating in parallel can run a broad range of cell therapy manufacturing instruments already in use by the industry, minimizing the need for process modifications while maximizing output.

Although the cell and gene therapy sector is advancing, innovative manufacturing solutions are needed to improve scalability and commercial viability, according to the Alliance for Regenerative Medicine (ARM).

“With current autologous therapies, manufacturing at scale is generally limited by a reliance on highly skilled experts for in-process decision making, manual operations, and the use of open processing in separate cleanrooms or isolators for each patient,” ARM pointed out in a November 2025 whitepaper based on takeaways from a scientific workshop.

The bottom line: automated, closed, and digitized manufacturing processes are necessary to reduce product variability, decrease cost of goods sold (COGS), and achieve scalability.

“When digitization, AI, automation, and robotics converge, one can imagine a ‘cell therapy factory of the future’ where COGS are substantially reduced and overall scalability is increased,” ARM concludes.