Drug substance
RNA identity, integrity, capping, Poly(A), impurities, oligo identity/purity and vector architecture.
RNAOS Workflows
Connect analytical workflows across RNA, nanoparticles and advanced therapies.
RNAOS brings assay execution, scientific context, provenance, review and reporting into one environment. Start with the workflow that matters today and expand across your program over time.
Core workflows
Focused workflows available for customer pilots.
Use representative data to evaluate calculations, traceability, review and reporting in the context of your current analytical process.
Particle size / Taylor dispersion
Smoothing, peak regioning, multi-component fitting, hydrodynamic diameter, uncertainty, setup metadata, workflow history, governed records and report artifacts.
Available for pilotEncapsulation efficiency
Paired total/free RNA inputs, Gaussian fitting, AUC, RMSE, fitted traces, encapsulation percentage, persistence and reporting.
Available for pilotRNA integrity by CE
Persistent raw files, peaks, sample metrics, algorithm version, governed record, review and reporting path.
Available for pilotRNA integrity by HPLC
Raw files, chromatographic peaks, integrity metrics, evidence assessment, persistence and governed-record baseline.
Available for scoping
Drug product
Encapsulation, particle size, zeta/pKa, integrity, residual solvents, potency and packaged species.
QC, release and stability
Method planning, stability intelligence, reports, audit trails, connectors and governed review.
Additional assay coverage
Extend RNAOS to the analytical methods used across your program.
Talk to us about the workflows, data formats and review requirements relevant to your methods.
Available for scoping
5′ capping
HPLC processing with LC-MS and enzymatic response normalization, source manifest, canonical snapshot and review/signature.
Available for scoping
DLS / MALS
Raw data and metadata ingestion, parameters, results, QC flags, governed snapshot and review.
Available for scoping
Poly(A) by CE or LC
Calibration, peak and distribution workflows with source evidence, calculations and governed outputs.
Available for scoping
Oligo purity and identity
Chromatography, LC-MS and CE/CGE workspaces with assignments, evidence digests and review.
Available for scoping
RiboGreen
Plate assignment, outlier handling, linear/4PL regression, extrapolation flags and well-level provenance.
Available for scoping
NGS and viral-vector CQA
Versioned sequencing and vector workspaces for identity, architecture, packaged species and safety/purity framing.
Planning & development
Connect analytical evidence with the decisions around it.
RNAOS also brings planning, formulation, stability, technology transfer and development context into the same program environment.
Planning workspace
LNP formulation predictor
Forward prediction, inverse design, scope gating and iterative DOE studies.
Planning workspace
CMC & CQ Strategy Mapper
Modality-, stage-, DS/DP- and authority-aware control-strategy blueprints.
Planning workspace
Stability Intelligence
Study design, scheduling, trends, uncertainty and out-of-trend support.
Planning workspace
Scale-up & tech transfer
Comparability, analytical bridge, critical parameters and site-handoff planning.
Planning workspace
Submission planning
Connect evidence gaps, dossier readiness, owners and dependencies around the development plan.
Planning workspace
Nonclinical and clinical planning
Species rationale, safety-package design, dose strategy, biomarkers and study linkage.