Technology — RNAnalytics

From wet‑lab execution to filing‑ready outputs

RNAnalytics combines validated physical toolkits (RNABOX) with a cloud‑native software hub (RNAOS) to standardize how RNA/LNP assays are executed, interpreted, trended, and reported across R&D, CMC, and QC.

Core system design

✓Workflow engine: standardized analysis blocks (import → QC → evaluation) mapped to batch-centric execution.
✓Device‑agnostic ingestion: heterogeneous file formats processed into one structured environment.
✓Audit transparency: audit trails, user management, and preserved instrument metadata.
✓API‑ready: architecture designed for ELN/LIMS integrations.

Implementation stack: Python/Django backend and React frontend.

CTD-native data model

✓Data model aligned to CTD Module 3 with separation of scientific content and regulatory operations layers.
✓Traceable linkage from raw data to final submission document; minimizes manual transcription risk.
✓Roadmap: automated generation of regulatory-ready reports and CTD-structured content export; later eCTD-ready outputs.

RNABOX toolkits

Consumable kits on existing lab infrastructure (initial focus: size; encapsulation efficiency next) enabling standardized wet‑lab execution.

RNAOS analytics

Interpretation layer built for high resolution in the RNA‑relevant nanoparticle window and workflow‑ready outputs.

Regulatory automation

Comparability and stability trending → CTD Module 3 generator (data-backed tables and plots) → later publishing compatibility.

18–24 month milestones (high level)

Scale RNABOX production; harden RNAOS for multi‑tenant SaaS (permissions, audit exports, dataset versioning, multi‑site workspaces); ship comparability + stability trending; deliver CTD Module 3 generator; prepare for later publishing compatibility.

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