Native-Read RNA Sequencing

RNA Clarity

Two researchers in lab coats discussing data on a screen beside a microscope.
RNA Clarity is Renew Biotechnologies’ native-read sequencing platform for direct characterization of RNA therapeutics and complex RNA products.
By combining native RNA sequencing and bioinformatics workflows tailored to RNA therapeutics, RNA Clarity enables integrated analysis of transcript identity, abundance, integrity, structural features, and process-related impurities.
Using Oxford Nanopore direct RNA sequencing, RNA Clarity profiles RNA directly without reverse transcription or PCR amplification, preserving transcript-level context for therapeutic development and QC characterization.

RNA Clarity Supports Multi-Attribute Characterization and QC of Complex RNA Products

Integrated Transcript Characterization

Generate Transcript-Resolved Insights Across RNA Therapeutics
Multivalent RNA Product Analysis
Resolve individual RNA components within multivalent or multi-construct formulations.
Multi-Attribute Characterization
Assess transcript identity, abundance, integrity, poly(A) features, and epitranscriptomic signals.
RNA Product Development
Support formulation optimization and analytical characterization during development.

QC and GMP Release Support

Support Regulated RNA Product Testing and Release Workflows
Identity and Composition
Confirm expected RNA components and relative transcript representations.
Component-Level Comparability
Evaluate transcripts across batches, lots, and process changes.
Impurity and Contaminant Detection
Detect RNA impurities, degradation products, and contaminants impacting quality.

Technical Differentiation

Key Advantages

Analyze complex formulations with 20+ RNA transcripts
Assess key quality attributes in a single sequencing assay
Generate transcript-resolved measurements across formulations

Platform Architecture / Workflow

Drug substance or LNP-formulated product intake
RNA extraction and direct RNA library preparation
Oxford Nanopore direct RNA sequencing
Reference alignment and transcript assignment
Standardized RNA Clarity report delivery
Characterization & QC
Platform Performance
Data Outputs

Multi-Attribute
Characterization & QC

RNA Clarity combines direct RNA sequencing with product-specific bioinformatics to characterize RNA therapeutics across multiple quality, structural, and performance attributes within a single workflow.
  • RNA Attribute
    What It Supports
  • Transcript Identity
    Confirmation of expected RNA components against product-specific references
  • Relative Abundance
    Observed versus expected transcript representation across formulations
  • RNA Integrity
    Component-level intact RNA percentage and coverage uniformity
  • Poly(A) Characterization
    Poly(A) tail length and integrity by transcript
  • Component Assignment
    On-target, off-target, and unclassified read assignment
  • Contaminant Assessment
    Detection of unexpected or non-target RNA species
  • Sequencing Quality
    Total reads, pass rates, quality metrics, and read-length distributions
  • Complex Formulations
    Transcript-resolved analysis of formulations containing 20+ RNA components

Platform Performance

RNA Clarity has been evaluated in blinded studies designed to assess transcript-level quantification, reproducibility, and detection of construct-level variation across complex mixtures.

In representative validation datasets, the platform demonstrated strong agreement between expected and observed transcript abundance, reproducible performance across operators and runs, and detection of transcript-level sequence variation and off-target RNA species.
  • Performance Area
    Representative Result
  • Complex Therapeutic Formulation
    20+ RNA transcripts
  • Relative Abundance Linearity
    R² > 0.99
  • Precision Across Operators
    CV < 5%
  • Mutation and Contaminant Detection
    Detected in Blinded Challenge Samples
Figure 1. Representative blinded performance data from multicomponent RNA formulation study. Summary table of RNA Clarity performance across key assay areas, including relative abundance linearity, precision, and mutation/contaminant detection, with representative results from blinded multicomponent RNA formulation testing.

Bioinformatics & Data Outputs

RNA Clarity delivers standardized, interpretable outputs designed for RNA therapeutic development, comparability studies, and QC workflows.
Two-page mRNA vaccine QC report with client details, data tables, and quality control graphs.
  • Included Data Outputs
    Description
  • RNA Clarity QC Report
    Summary of sequencing performance and RNA product characterization
  • Transcript-Level Summary Tables
    Identity, abundance, integrity, and poly(A) metrics by component
  • Visual QC Outputs
    Quality, coverage, abundance, poly(A), and contamination plots
  • Reference-Based Analysis
    Alignment and assignment against customer-specific reference files
  • Contamination Summary
    Detailed review of non-target and unclassified RNA species
  • Optional Technical Support
    Custom analyses and post-project review with Renew scientists

Development-to-Validation Support

For exploratory, development, and verification projects, Renew provides end-to-end bioinformatics support, including reference setup, transcript assignment, QC review, custom analysis, and interpretation of RNA integrity, abundance, structure, and contaminant outputs.

For GMP-level validations and other regulatory programs, Renew supports assay planning, analytical performance studies, QA-reviewed reporting, and submission-ready validation documentation.
Explore RNA Clarity for Your Therapeutic Program
Contact us to discuss pilot studies, analytical development, and QC support.
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