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Dillico describes All-ScaleFlow as an automated platform connecting mRNA synthesis, purification and lipid nanoparticle (LNP) formulation. Its named operations include semi-continuous in-vitro transcription (IVT), multi-column chromatography, single-pass tangential-flow filtration (TFF) and LNP mixing. That is an integrated process architecture; it is not, by itself, independent proof of validated commercial GMP performance across the platform’s advertised range.
What is All-ScaleFlow?
All-ScaleFlow is Dillico’s manufacturing platform for RNA-LNP products. The company says it brings synthesis, purification and formulation into one automated workflow. Dillico calls it “the world’s first end-to-end continuous mRNA manufacturing platform”; that is the company’s description, not an independently established industry-wide finding.
The distinction between an integrated workflow and an uninterrupted continuous process matters. Dillico specifically describes its IVT step as semi-continuous. Connecting several unit operations does not establish that every operation runs continuously, without pauses, or under the same operating mode.
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Dillico’s public materials describe a process that moves from RNA production through purification to LNP formulation. The named operations fit into this sequence:
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- mRNA synthesis: Semi-continuous IVT produces the RNA.
- Purification: Multi-column chromatography and single-pass TFF are the named purification operations.
- LNP formulation: The RNA is combined with lipids through LNP mixing.
The company presents these steps as connected within an automated workflow. Public descriptions do not provide enough detail to determine the exact operating conditions, transfers, hold points, or control strategy for each step.
How does Dillico say the platform scales?
Dillico’s scale-up proposition is to keep the same process and increase output by running it longer, rather than by enlarging batch volumes. The company frames All-ScaleFlow as suitable from early development through commercial production. A conference abstract by Dillico authors also describes using the same equipment from small preclinical quantities through commercial scale.
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The abstract lists real-time control, fewer hold times, flexibility and lower raw-material consumption as benefits. These are vendor-presented claims, not independent comparative results in the available evidence. The sources reviewed do not independently demonstrate the platform’s full development-to-commercial range or establish cross-scale product comparability.
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Dillico’s current All-ScaleFlow equipment page, accessed in 2026, publishes these specifications. They are vendor claims, not independently verified measurements in the cited material.
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| Published specification | Dillico’s stated value | Evidence qualification |
|---|---|---|
| Minimum scale | 455 doses | Published by Dillico; independent verification is not established in the cited evidence. |
| Annual capacity | 13 million mRNA doses | Published by Dillico; operating assumptions and independent verification are not established in the cited evidence. |
| Equipment footprint | 2 m² | Published by Dillico; independent verification is not established in the cited evidence. |
These figures do not, on their own, specify the product, dose definition, operating schedule, facility requirements or quality controls behind the capacity estimate. Those details matter when translating a published specification into a manufacturing plan.
What does the Process Simulator do?
Dillico describes a Process Simulator for recipe and workflow management. According to the company, it uses RNA sequence and sequence length, target in-process controls, critical quality attributes, throughput and customer constraints to generate feasible operating ranges and master-recipe parameters.
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The public description does not explain the simulator’s algorithms or provide enough information to independently assess its predictions. It should therefore be understood as a described platform capability, not evidence that generated recipes have been validated for a particular product or manufacturing setting.
What independent evidence exists for continuous RNA-LNP manufacturing?
Peer-reviewed work shows that continuous or scalable LNP manufacturing is an active technical area, but these studies concern different processes and do not validate All-ScaleFlow.
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- A 2022 Scientific Reports paper reports a design-of-experiments-derived continuous LNP process, with a target particle-size range of 60–180 nm and a scale-up evaluation. Those results apply to the process described in that paper, not to Dillico’s platform.
- A 2023 PNAS study describes SCALAR, a silicon-and-glass system with 256 mixing units for scalable RNA-LNP manufacture. It is an example of a different formulation architecture, not a head-to-head assessment of All-ScaleFlow.
ARPA-H separately lists ESCALATOR, a funded development program for a benchtop continuous-flow system intended to integrate RNA production, LNP formulation, fill-finish and automated quality control. ARPA-H identifies Waterfall Scientific as prime awardee, gives a start date of August 25, 2026, and lists an award of up to $46.9 million. This is a development effort, not evidence of a commercially available platform or of All-ScaleFlow performance.
What should a buyer verify before relying on the claims?
The available public descriptions establish what Dillico says the platform integrates and how it proposes to scale. They do not independently establish commercial GMP production across the full advertised range, validated performance for a specific product, or a head-to-head advantage over batch manufacturing.
For a technical or procurement assessment, ask for evidence that connects the advertised architecture to the intended product and operating scale:
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- Which steps run batch, semi-continuously or continuously, and where are hold points or transfers?
- What throughput and dose assumptions underlie the capacity figures, and what operating conditions are required?
- What quality-system and process-monitoring documentation supports the control strategy?
- What product-quality data and comparability evidence support operation at different scales?
- What validation and customer evidence supports GMP use and the claimed scale range?
- What changeover, sequence-flexibility, facility and technology-transfer requirements apply?
Those questions distinguish a compelling integrated process concept from demonstrated performance for a particular manufacturing use.
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