Cell and gene therapy processes built for early trials may not always be ready for commercial supply, where consistency, capacity, cost, analytics, and quality systems become harder to separate.
In the following interview, Eytan Abraham, Chief Commercial & Technology Officer at Minaris Advanced Therapies, discusses the manufacturing decisions that shape advanced therapy programs from development through commercialization.
What are the biggest manufacturing challenges facing cell and gene therapy developers as the field moves toward commercial scale?
As more cell and gene therapies advance toward commercialization, the central question is whether the manufacturing model can reliably support patients at scale.
The biggest challenges are consistency, capacity, cost of goods, process robustness, analytical readiness, and maintaining quality across increasingly complex clinical and commercial supply chains. These therapies are biologically complex and often individualized, meaning variability is frequently inherent in the starting material, the process, or both. Sponsors must design manufacturing strategies that can manage that variability while still delivering reliable, compliant, and reproducible outcomes.
Timing is another critical challenge. Demand can increase rapidly once a therapy progresses into late-stage trials or reaches the market. If the manufacturing process, supply chain, analytics, and quality systems were not designed with that future state in mind, scaling becomes far more difficult and costly.
Commercial manufacturing requires a higher level of operational discipline, documentation, and predictability. The organizations that succeed are those that treat manufacturing as a strategic pillar of development from the outset.
Is manufacturing success determined earlier than some sponsors realize?
Manufacturing success is shaped long before a product reaches pivotal trials or commercial launch. Early development decisions can either create long-term flexibility or introduce constraints that are difficult and expensive to unwind.
Sponsors need to determine whether a process can be executed consistently, transferred effectively, supported by reliable raw material supply, and scaled within a GMP framework. A process that works scientifically at small scale is not necessarily prepared for clinical progression, commercial readiness, or broader patient access.
Choices related to process design, raw materials, analytical methods, equipment platforms, automation, comparability strategy, and tech transfer documentation all influence scalability. In cell and gene therapy especially, the process is closely tied to the product. That means manufacturing changes can have regulatory and comparability implications.
Bringing a commercial manufacturing mindset into development early, allows sponsors to avoid preventable delays, manage costs more effectively, and support long-term patient access.
How can early decisions around process development, analytical development, and tech transfer affect speed, cost, and regulatory readiness later on?
Early decisions directly influence how efficiently a program progresses.
Robust process development establishes a manufacturing approach that is repeatable, well-characterized, and practical to execute in GMP environments. Early evaluation of manufacturability – whether the process can be consistently performed, transferred, scaled, and analytically supported – reduces variability and creates a clearer path to scale-up or scale-out.
In terms of analytical strategy, without strong methods to characterize and control the product, sponsors may face clinical and regulatory uncertainty or delays later in development.
Tech transfer is often underestimated and should be considered the structured translation of process knowledge into a new GMP setting where execution must be consistent, compliant, and time-sensitive. If process rationale, historical data, critical parameters, and analytical approaches are not well understood and documented, valuable time can be lost resolving avoidable issues.
Well-informed early decisions accelerate development, control downstream costs, and strengthen the link between process understanding, product quality, and regulatory expectations.
What does “manufacturing innovation” really mean in advanced therapies?
In advanced therapies, innovation must serve reliability, scalability, and access – it cannot be innovation for its own sake.
The most impactful innovations are often practical: automation that reduces variability and cost, closed systems that lower contamination risk, improved analytics that deepen process understanding, digital tools that enhance traceability and documentation, and facility designs that improve operational flow.
Innovation must also withstand the realities of regulated manufacturing. A new technology may be compelling, but if it cannot be validated, transferred, maintained, and operated consistently under GMP conditions, it may not ultimately benefit patients.
For sponsors, the guiding question should be: does this innovation make the process more dependable, scalable, and commercially viable? If the answer is yes, and it aligns with regulatory expectations, it can have meaningful benefits.
Where do sponsors most often run into problems when moving from clinical manufacturing to commercial readiness?
Challenges often arise when the clinical manufacturing process was not designed with the commercial end state in mind.
A process suitable for a limited number of clinical batches may not be efficient, economical, or robust enough for sustained commercial supply. Sponsors may encounter issues such as excessive manual intervention, raw material constraints, insufficient analytical depth, long turnaround times, documentation gaps, comparability challenges, or limited process understanding.
Commercial manufacturing also requires disciplined scheduling, capacity planning, quality oversight, deviation management, release coordination, and supply continuity – often at a scale and predictability that differs substantially from early-stage operations.
Another common issue is engaging manufacturing partners too late, or failing to pressure-test the process against future demand scenarios. By the time a program enters late-stage trials, making structural process changes can introduce regulatory complexity and timeline risk.
The transition from clinical to commercial manufacturing is a gradual progression that should be built into development planning from the beginning.
Looking ahead, what needs to change to make advanced therapies more scalable, reliable, and accessible to more patients?
The industry must continue shifting toward earlier manufacturing planning, stronger process and analytical foundations, more efficient tech transfer models, and pragmatic innovation that withstands GMP scrutiny.
Greater standardization, where scientifically appropriate, can help reduce variability and improve reproducibility. Investment in automation, digitalization, and infrastructure will also be critical as more therapies reach commercialization.
Collaboration will play a central role. Therapy developers, CDMOs, regulators, technology providers, and healthcare systems must align earlier and more strategically. Scalability and access cannot be solved by any single stakeholder.
As more advanced therapies reach the market, reliability becomes just as important as scientific breakthroughs. Patients depend not only on innovation, but on dependable supply.
Ultimately, success will come when advanced therapies become less exceptional from a manufacturing standpoint. They will always be complex, but the pathway from development to commercial supply must become more predictable, efficient, and scalable. That is how the field moves from individual success stories to broad patient access.
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