Scaling Bottlenecks in Biomanufacturing: The Structural Challenges We Need to Solve
Lessons from the Advanced Biotech for Sustainability (AB4S) Report on why bio-based innovation stalls – and what it will take to unlock scale
Biotech innovation has accelerated. Engineering tools are more sophisticated, organism design more precise, and datasets more abundant. Yet despite this progress, the biomanufacturing industry remains stuck – unable to move beyond lab-scale success into widespread industrial deployment.
The Advanced Biotech for Sustainability (AB4S) report diagnoses this challenge with uncommon clarity. In Chapter 3, the report identifies a systemic failure to scale – not due to technical feasibility, but due to structural bottlenecks embedded in how biotech is built, financed, and operated.
At Arsenale, we see these same bottlenecks from the inside. And we agree: scaling isn’t a phase. It’s a design problem.
Three Core Bottlenecks Blocking Biomanufacturing Scale
The barriers to scale are not one-off exceptions. They are patterned, predictable failures – systemic friction points that stall even the most promising technologies.
1. Infrastructure Bottlenecks
Biomanufacturing scale-up is constrained by a lack of access to production-relevant facilities. Most existing infrastructure is proprietary, siloed, or tailored to one process. The report notes: “Limited availability of modular, flexible facilities is delaying scale-up and increasing costs across the board.”
2. Translation Bottlenecks
Processes that work in controlled lab conditions often fail under industrial constraints. Variability, scale effects, and context-specific parameters are poorly modeled. AB4S highlights the consequence: “High failure rates during scale-up due to insufficient translation from R&D to industrial environments.”
3. Capital Bottlenecks
The capital required to build and operate at scale does not match the risk profile or timeline of current biotech ventures. Venture capital isn’t designed for process infrastructure. And project finance is hesitant without proven repeatability. The result: a dead zone between innovation and impact.
These Bottlenecks Are Not Inevitable – They’re Designed
What makes these challenges difficult is not their complexity – it’s that they’re deeply structural. They stem from how the industry has been organized: around one-off pilots, disconnected tools, and hardware that doesn’t scale.
As AB4S frames it, scale-up has too often been treated as a linear extension of R&D, rather than a systems-level constraint requiring its own infrastructure, economics, and governance.
The question is not how to optimize within this model. The question is how to replace it.
Arsenale’s Approach: Designing Out the Bottlenecks
At Arsenale, we’re building the industrial infrastructure the bioeconomy has been missing.
Integrated infrastructure: Our bioyards are built to simulate and sustain production conditions – at multiple scales and with high instrumentation. We treat infrastructure not as a cost center, but as a generator of actionable industrial data.
Process design for scale: Our platform supports Design@Scale, minimizing the translation gap between lab insights and real-world execution. Scale effects are built into early-stage design decisions.
Infrastructure-as-a-platform: We develop replicable systems that enable modular expansion, reducing the need for bespoke builds and derisking investment across geographies and applications.
Each of these is aimed at the same outcome: removing friction from scale by addressing it as a first-order design principle.
From Bottlenecks to Enablers
The AB4S report doesn’t just outline what’s broken – it points to what’s possible. It reframes scale-up as an infrastructure and coordination challenge, not just a technical one. Solving this is the central task of the bioeconomy’s next chapter. Not more prototypes. Not more parallel pilots. But a new operating model – one designed to scale.