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Dillico describes All-ScaleFlow as an automated workflow linking mRNA synthesis, purification and lipid nanoparticle (LNP) formulation. Its named operations are semi-continuous in-vitro transcription (IVT), multi-column chromatography, single-pass tangential-flow filtration (TFF) and LNP mixing. The integration is the central proposition; it is not, by itself, proof that every operation runs without interruption or that commercial GMP performance has been validated across the platform’s advertised range.
What does All-ScaleFlow integrate?
All-ScaleFlow is Dillico’s platform for connecting several steps in RNA-LNP manufacturing in one automated workflow. IVT makes the RNA; purification operations remove unwanted process material; and LNP mixing formulates the RNA into lipid nanoparticles. Dillico identifies multi-column chromatography and single-pass TFF as purification operations in the connected process.
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“End-to-end” describes the span of operations the company says it integrates. It should not be read as evidence that every operation is continuously flowing at every moment: Dillico specifically calls IVT semi-continuous. The public description does not establish the detailed transition, hold, or control behavior between every unit operation.
How does Dillico describe the scale strategy?
Dillico says the platform is intended to serve development through commercial production by extending the process run time rather than moving to larger batch volumes. In principle, that is a run-longer approach to increasing output. The company’s conference abstract also says the same equipment can be used from small preclinical quantities through commercial scale, and attributes real-time control, fewer hold times, flexibility and lower raw-material consumption to the approach. Those are vendor statements, not independently established comparative results.
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The equipment page publishes these specifications:
| Published figure | Dillico’s stated specification | Evidence qualification |
|---|---|---|
| Minimum scale | 455 doses | Dillico equipment-page claim, accessed in 2026; not an independently verified measurement in the cited evidence. |
| Annual capacity | 13 million mRNA doses | Dillico equipment-page claim, accessed in 2026; the cited evidence does not independently establish achieved production at this capacity. |
| Equipment footprint | 2 m² | Dillico equipment-page claim, accessed in 2026; not an independently verified measurement in the cited evidence. |
These figures are useful as published vendor specifications, but they do not by themselves show the operating assumptions behind a dose count, demonstrate a sustained production run, or establish performance at every point between the stated minimum and annual capacity.
What role does the Process Simulator play?
Dillico describes a Process Simulator for recipe and workflow management. According to the company, it takes RNA sequence and sequence length, target in-process controls, critical quality attributes, throughput and customer constraints as inputs, then generates feasible operating ranges and master-recipe parameters.
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The public description does not explain the simulator’s algorithms or provide enough detail to independently assess how its recommendations are generated or validated. For a technical evaluation, useful questions include how predictions are checked against experimental runs, how uncertainty is handled, and how changes in sequence or process requirements affect the resulting recipe.
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Peer-reviewed studies show that continuous or scalable RNA-LNP manufacturing is an active technical area. They provide context for the engineering problem, not performance evidence for All-ScaleFlow.
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- A 2022 Scientific Reports paper reports a design-of-experiments-derived continuous LNP process, a target particle-size range of 60–180 nm, and scale-up evaluation. Those results belong to the process studied in that paper; they should not be attributed to Dillico.
- A 2023 PNAS study describes SCALAR, a silicon-and-glass system with 256 mixing units for scalable RNA-LNP manufacture. It is a different formulation architecture, not a direct test or comparison of All-ScaleFlow.
- ARPA-H lists ESCALATOR as a separate funded development program led by Waterfall Scientific as prime awardee. Its stated aim is a benchtop continuous-flow system integrating RNA production, LNP formulation, fill-finish and automated quality control. ARPA-H lists a start date of August 25, 2026, and an award of up to $46.9 million. The award describes a development effort, not a commercially available product.
A trade-publication article has also described Precision NanoSystems, now part of Cytiva, as offering an integrated single-use manufacturing line spanning RNA drug substance to RNA-LNP drug product. That description is an adjacent vendor reference; the cited material does not establish current availability, equivalence to All-ScaleFlow or partner terms.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What should a technical or manufacturing evaluation verify?
The public claims describe an integrated architecture and a scale proposition. The available sources do not independently establish commercial GMP production across the full advertised range, cross-scale product comparability, or a head-to-head advantage over batch alternatives. A prospective evaluator should request evidence specific to the intended process and product rather than treating platform-level descriptions as validation.
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- Unit operations: Which steps are integrated, and which remain separate? For each operation, is it batch, semi-continuous or continuous?
- Scale evidence: What throughput has actually been demonstrated, under what run conditions, and at which scales? What evidence supports claims spanning development to commercial production?
- Product quality: What quality data and comparability evidence are available across scales, sequences and relevant process changes?
- Monitoring and control: Which process parameters and in-process controls are monitored, and how are they connected to quality-system documentation?
- Operational flexibility: What changeover and sequence or modality flexibility has been demonstrated, and what are the associated requirements?
- Deployment and transfer: What facility requirements, footprint assumptions and technology-transfer evidence apply to the proposed installation?
- GMP readiness: What validation package, regulatory and quality documentation, and customer evidence support the intended commercial use?
Answers to these questions would distinguish the platform’s integration concept and published specifications from evidence of validated performance in a particular manufacturing setting.
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