The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations

The cell therapy sector is entering a defining moment.
As therapies move faster toward commercialization and regulatory agencies continue refining expectations for advanced therapies, companies are facing a new reality. Strong clinical data alone are no longer enough. Sponsors must build regulatory and CMC strategies that evolve in parallel with clinical development from the very beginning.
That was the central theme of RoslinCT’s recent webinar with GEN, The 2026 Cell Therapy Regulatory Landscape: Aligning CMC Strategy with FDA and EMA Expectations. The discussion brought together leaders from across the industry to explore how sponsors can navigate evolving FDA and EMA expectations while avoiding the common pitfalls that continue to delay promising therapies.

The panel featured:

• Catherine Tomaro-Duchesneau, PhD, Senior Director of Manufacturing and MS&T, RoslinCT
• Jonelle Chapman, PharmD, Head of Regulatory Affairs, Cell Medicines, Regeneron
• Kathy Burri, Head of Quality, RoslinCT, who moderated the discussion
• Tiffany Lucas, PhD, Regulatory Affairs Practice, U.S., Eliquent Life Sciences

Throughout the webinar, one message came through clearly: flexibility from regulators does not mean lower expectations.

Flexibility Does Not Mean “Less”

Recent FDA messaging around CMC flexibility has generated significant discussion across the cell and gene therapy industry. However, as Tiffany Lucas explained during the webinar, the agency’s position is often misunderstood.

“The flexibility has always existed because these products are unique,” Lucas noted. “But sponsors still need to come forward with a well-thought-out strategy supported by strong scientific rationale and data.”

For cell therapies, there is no universal development playbook. Every product comes with unique manufacturing challenges, analytical considerations, and quality risks. Regulatory flexibility allows sponsors to apply science-based approaches that are appropriate for their product, but the burden remains on the sponsor to justify those decisions.

This is particularly important when it comes to potency assays, analytical methods, and process understanding. While regulators may accept phase-appropriate approaches early in development, sponsors still need a roadmap that demonstrates how those systems will mature over time.

The panel emphasized that flexibility without process understanding can create major commercial risks later.

A manufacturing process that lacks robustness in early development can become extremely difficult to scale, validate, or compare once programs move toward pivotal studies or commercialization.

The Growing Gap Between Clinical Speed and CMC Readiness

One of the most important discussions during the webinar centred on the growing disconnect between rapid clinical advancement and slower CMC maturity.

Jonelle Chapman highlighted a pattern many sponsors know well. Early clinical success often accelerates programs into registrational studies before manufacturing systems are fully ready.

“Clinical development can move very quickly in cell therapy,” Chapman explained. “But bringing a complex manual process to commercial scale takes time.”

This challenge is especially pronounced in autologous cell therapy programs, where early manufacturing may rely on highly manual workflows developed in academic settings.

As programs advance, sponsors suddenly face difficult questions:

• Can the process scale reliably?
• Are analytical methods sufficiently developed?
• Is the potency strategy robust enough for commercialization?
• Can manufacturing changes be supported with comparability data?

According to the panel, many companies underestimate how difficult it becomes to address these questions late in development.

Strong clinical outcomes cannot compensate for missing CMC data. If critical analytical methods were not developed early or if stability and potency data were not collected appropriately, sponsors may find themselves unable to support licensure even with compelling efficacy data.

Potency Remains One of the Industry’s Biggest Challenges

Again and again, panellists pointed to delayed potency development as one of the most common and costly mistakes in cell therapy programs.

Catherine Tomaro-Duchesneau stressed that many organizations focus heavily on manufacturing process development while underinvesting in analytical development.

“We often see the analytics lagging behind the manufacturing process,” she explained.

That disconnect creates major downstream risks.

Without meaningful potency assays in place, sponsors cannot confidently evaluate process changes, assess comparability, or fully understand product quality impacts. Even seemingly straightforward improvements, such as moving from manual to automated systems, may introduce unexpected changes to cell behavior or therapeutic function.

The panel strongly encouraged companies to begin potency development early, even if methods are initially imperfect.

Waiting until late phase development to establish analytical strategies can create significant delays, increased costs, and in some cases, regulatory barriers that are difficult to overcome.

Why Early CDMO Engagement Matters

If you’re expecting the answer to be AI, the webinar offered a reality check. 

Another major theme from the webinar was the value of engaging experienced CDMO partners early.

According to the panellists, the difference between programs that involve CDMOs strategically from the start versus those that wait until later stages is often immediately visible.

Early partnerships help sponsors think beyond proof of concept and begin addressing practical manufacturing realities such as:

• GMP readiness
• Process robustness
• Data integrity
• Raw material qualification
• Automation strategy
• Scale out planning
• Technology transfer risks

Tomaro-Duchesneau emphasized the importance of manufacturing science and technology functions in bridging the gap between research processes and commercial manufacturing.

“Scientists may build a process that works in the lab,” she said, “but translating that into a reproducible GMP manufacturing process requires a very different mindset.”

Tiffany Lucas added that regulators can often identify whether a sponsor worked closely with an experienced CDMO simply by reviewing the submission package.

Strong CDMO partnerships tend to produce more cohesive regulatory strategies, better process characterization, and more mature risk assessments.

Importantly, the panel encouraged sponsors to treat CDMOs as true strategic partners rather than transactional service providers.

Keeping CDMOs integrated into regulatory discussions and health authority interactions can help align development strategies earlier and reduce surprises later.

Designing for Global Development From Day One

As cell therapy companies increasingly pursue global development strategies, the panel also explored the importance of planning for regional regulatory differences early.

FDA and EMA expectations continue to evolve independently in several areas, including risk-based approaches, out-of-specification handling, and manufacturing expectations.

The panel warned that treating global strategy as a “phase three problem” can create major lifecycle management challenges later.

Small differences introduced during regional submissions or manufacturing changes can eventually lead to diverging specifications, comparability challenges, or added operational complexity.

Sponsors were encouraged to think proactively about:

• Future manufacturing changes
• Commercial scale requirements
• Regional regulatory expectations
• Lifecycle management planning
• Long-term analytical validation strategies

The earlier those considerations are incorporated into development planning, the easier it becomes to maintain alignment across regions.

Intelligent Risk Management Starts Early

One of the strongest takeaways from the discussion was the importance of thoughtful, science-driven risk assessment.

For regulators, risk assessments are not simply procedural exercises. They are evidence of process understanding.

The panel encouraged sponsors to define clearly:

• Why a change is being made
• What quality attributes could be impacted
• How those risks will be evaluated
• What success criteria will be used
• Which analytical tools support the assessment

Importantly, panellists noted that successful risk management depends on cross-functional collaboration among regulatory, CMC, manufacturing, quality, and supply chain teams.

In complex cell therapy programs, many of the most important risks exist between functions rather than within them.

Advice for Emerging Cell Therapy Companies

Toward the end of the webinar, the panellists shared practical advice for companies building first-generation cell therapy programs.

Their recommendations were remarkably aligned.

Invest early in:

• Strong regulatory CMC leadership
• Potency and analytical development
• MS&T expertise
• Cross-functional integration
• Strategic CDMO partnerships
• Robust gap assessments

Most importantly, sponsors should avoid assuming that CMC can “catch up later.”

In today’s regulatory environment, manufacturing and analytical maturity are becoming just as important as clinical momentum.

The companies that succeed will be the ones that integrate regulatory strategy, manufacturing science, and clinical development from the very beginning.

Looking Ahead

The regulatory landscape for cell therapy continues to evolve rapidly, but one principle remains constant.

Regulators are open to innovation. They are willing to consider flexible and product-specific approaches. But they still expect sponsors to demonstrate deep scientific understanding, robust process control, and a clear path toward commercialization.

For cell therapy developers, that means investing earlier, planning further ahead, and building partnerships that support long-term success.

As the industry moves into 2026 and beyond, the organizations best positioned for success will be those that treat CMC strategy not as a downstream function, but as a central driver of clinical and commercial readiness.