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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

Explore The Resource

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.

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.

This service framework supports:
Exploratory RNA product characterization
Process development and formulation assessment
Batch and lot comparability studies
Development verification and performance benchmarking
GMP validation planning and execution
Submission-ready analytical and QC documentation

Questions & Answers

What types of RNA products are compatible with RNA Clarity?

RNA Clarity supports purified drug substance and formulated RNA products, including single-transcript products, LNP-formulated therapeutics, and complex multivalent formulations. Project-specific compatibility is assessed based on product composition, concentration, formulation, and analytical goals.

What quality attributes does RNA Clarity measure?

RNA Clarity assesses transcript identity, relative abundance, RNA integrity, coverage uniformity, poly(A) tail length and integrity, component assignment, unexpected RNA species, sequencing quality, and select epitranscriptomic signals.

Can RNA Clarity support multivalent or multi-transcript RNA products?

Yes. RNA Clarity provides transcript-resolved analysis of multivalent and multi-construct formulations containing more than 20 RNA components, enabling component-level assessment of identity, relative abundance, integrity, and poly(A) features.

What information is included in an RNA Clarity report?

Reports include transcript identity and assignment, observed component abundance, intact RNA percentage, coverage uniformity, poly(A) characterization, on-target and off-target reads, contaminant assessment, and sequencing QC metrics. Report content may be tailored to the product and study objectives.

What sample or reference materials are required to run RNA Clarity?

RNA Clarity accepts drug substance or formulated RNA products. Product-specific reference sequences are required for transcript alignment and component assignment. Final input, volume, concentration, and reference requirements are established during project scoping.

Can RNA Clarity support batch comparability or lot release workflows?

Yes. RNA Clarity can compare transcript-level identity, composition, abundance, integrity, poly(A) features, and impurities across batches, lots, and process changes. Release use requires fit-for-purpose assay validation and predefined specifications.

How does Renew support assay verification, validation, or GMP-readiness for RNA Clarity?

Renew supports reference setup, method development, performance characterization, validation planning and execution, QA-reviewed reporting, and submission-ready documentation. Programs can be structured for exploratory characterization, development benchmarking, batch comparability, or GMP-oriented testing.

What additional quality attributes are under development for RNA Clarity?

Renew is expanding RNA Clarity to support additional structural, chemical, and process-related attributes. Specific capabilities and development timelines are evaluated with partners based on product modality and program requirements.

Explore RNA Clarity for Your Therapeutic Program

RNA Clarity