Is EMA Opening the Door to Industrial Standards in CGT Manufacturing?
Over the past decade, cell and gene therapy (CGT) manufacturing has evolved under a largely bespoke paradigm. Each asset has tended to drive its own process, its own cleanroom configuration, its own raw materials, and often its own exceptions.
That paradigm is now under strain.
In H1 2026, the European Medicines Agency — through its ATMP-focused committees (CAT and CHMP) — is expected to advance discussions on platform manufacturing concepts, manufacturing variability, and the acceptability of modular or semi-standardised approaches across ATMPs.
On the surface, this may look like a technical regulatory discussion. In practice, it represents something more important:
a regulatory signal that manufacturing design itself is becoming a first-order consideration.
Why this conversation is happening now
Pressure has been building from multiple directions:
- Escalating COGS driven by bespoke facilities and labour-intensive processes
- Capacity fragility, particularly in autologous therapies with fragmented demand
- Limited scalability of artisanal manufacturing models
- Increasing recognition that manufacturing variability — not clinical science — is the binding constraint for broader patient access
Regulators are not static to these realities. What is changing is how variability and risk are being framed.
Rather than assuming that bespoke processes inherently reduce risk, there is growing acknowledgement that repeatable, well-controlled platforms may actually offer superior robustness.
Platform manufacturing: what regulators are really talking about
It is important to be precise. From a regulatory perspective, platform manufacturing does not mean “one process fits all”.
Instead, it implies:
- Reuse of qualified unit operations (e.g. cell selection, activation, transduction, fill/finish)
- Consistent automation logic and control strategies across products
- Defined and bounded sources of variability, supported by data
- Standardised raw material classes and supplier qualification frameworks
The product remains specific.
The manufacturing backbone does not.
This distinction is what makes the discussion viable from a regulatory standpoint.
Automation and closed systems: from efficiency tools to risk controls
A critical enabler of this shift is the changing regulatory perception of automation and closed systems.
Historically, automation in CGT has been justified primarily on:
- Cost reduction
- Labour availability
- Throughput
Increasingly, it is being reframed as a risk-reduction mechanism.
From a regulatory lens:
- Manual operations introduce operator-dependent variability
- Open systems increase contamination risk
- Bespoke steps complicate comparability and lifecycle management
By contrast, automated and closed systems offer:
- Deterministic execution
- Reduced operator interaction
- Lower reliance on high-grade cleanrooms
- Digitally traceable process data
In other words, automation is becoming a regulatory stabiliser, not just an operational optimisation.
From regulatory signal to operational design principle
If EMA meaningfully progresses this stance — even through soft guidance or precedent-setting assessments — the operational implications are material.
1. Facility design becomes platform-driven
Rather than cleanrooms optimised around a single asset, facilities can be designed around repeatable, automated unit operations, enabling:
- Smaller footprints
- Lower-grade rooms
- Higher utilisation across portfolios
2. CMC and MSAT shift to portfolio-level thinking
Platform logic encourages portfolio-level CMC and MSAT strategies, rather than asset-by-asset regulatory planning. This is a prerequisite for any form of industrialisation.
3. Capacity planning becomes more demanding — not less
For autologous therapies in particular, fragmented demand means platform manufacturing raises the bar on:
- Demand shaping
- Scheduling discipline
- Committing demand to manufacturing only when operationally viable
Industrialisation does not remove complexity — it forces it to be managed explicitly.
4. Raw material strategies begin to standardise
Acceptance of platforms supports convergence around:
- Raw material classes
- Supplier qualification frameworks
- Reduced proliferation of one-off materials and vendors
5. Late-stage process overhauls become harder to defend
As regulators grow more comfortable with platform logic, large post-approval process changes will become increasingly difficult to justify.
This shifts strategic weight toward choosing the right technology and automation platform earlier.
A small step — but a decisive one
If progressed, this direction would represent a small but highly consequential shift:
From bespoke exception-handling
to controlled industrial variability
This does not mean CGT will suddenly resemble traditional biologics manufacturing. But it does signal the beginning of the end of bespoke/artisanal CGT manufacturing as the default operating model.
Looking ahead
At Radix Partners, we have consistently highlighted that the future of advanced therapy manufacturing will be shaped by new industrial standards, emerging jointly from regulatory evolution and technology maturity.
Automation, closed systems, and platform thinking are no longer optional bets — they are becoming design principles for sustainable CGT manufacturing at scale.
The open question is no longer if this transition happens, but who designs for it early — and who is forced to react later.
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