Platforms
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RNA Therapeutics IVT Manufacturing Platform
An integrated IVT-based RNA drug substance CMC and GMP manufacturing platform supporting mRNA, saRNA, and circRNA programs from sequence design, IVT process development, capping / circularization, purification, analytical control, and GMP scale-up to LNP-ready RNA drug substance.
mRNA
saRNA
circRNA
LNP-ready RNA DS
Built for RNA CMC
IVT, capping, circularization, purification, analytics, and release testing.
GMP Scale-Up Proven
GMP mRNA and circRNA drug substance manufacturing with LNP-ready handoff.
RNA Platform Proof Points
Platform Scope
mRNA / saRNA / circRNA
Multi-modality IVT RNA DS platform for vaccines, protein replacement, gene editing, and cell therapy applications.
Process Options
Two Capping Routes
Enzymatic capping and co-transcriptional capping options for phase-appropriate process design.
circRNA Process
3 Circularization Strategies
T4 ligase, Group I intron, and Group II intron routes for circRNA process development.
Analytical Control
15+
RNA DS test capabilities covering identity, purity, capping, poly(A), dsRNA, residuals, and potency.
GMP Scale Proof
30g+
GMP mRNA drug substance production experience with low dsRNA control.
GMP Scale Proof
6g+
GMP circRNA drug substance production experience.
Ready-to-Use Research Tools
Ready-to-Use RNA Tools for Early Feasibility Studies
Standardized RNA research tools for reporter assays, delivery screening, platform evaluation, and early feasibility studies, available through a fast quote-and-shipment pathway.
RNA IVT Technical Strengths
CATUG supports both linear RNA and circRNA drug substance development with modality-specific IVT process design, capping or circularization strategies, impurity control, orthogonal analytics, and GMP scale-up know-how.
Upstream Design & IP
Sequence, UTR & Template System Optimization
CATUG supports RNA sequence optimization, proprietary high-expression UTR IP licensing, stable plasmid backbone design, and competent cell system screening to improve IVT template performance, RNA expression potential, process robustness, and downstream manufacturability.
IVT Process & Capping
IVT Process Development & Flexible Capping
Critical raw material screening, IVT parameter optimization, capping optimization, TFF and chromatography development, and scale-up studies support robust linear RNA drug substance processes with phase-appropriate capping route selection.
Long RNA Control
Long RNA / saRNA Integrity Control
Dedicated process strategies for long RNA molecules, including saRNA over 9,000 nt, support RNA integrity, template stability, purification robustness, and manufacturability from development to GMP scale.
Impurity Control
dsRNA Reduction & Impurity Control
Integrated dsRNA control strategies combine sequence optimization, nucleoside modification, IVT condition optimization, and post-IVT purification to reduce immunogenic impurities while balancing yield, integrity, and scalability.
Evidence Snapshot
Upstream IP
UTR IP Licensing
CATUG proprietary high-expression UTR IP available for customer programs.
Enzymatic Capping
97–100%
Theoretical enzymatic capping efficiency.
Co-Transcriptional Capping
95–99%
Typical co-transcriptional capping efficiency.
Long RNA Integrity
63% → 89%
saRNA integrity improvement after IVT and oligo-dT optimization.
GMP Capability
100 mg–100 g
GMP RNA drug substance manufacturing capability.
Linear RNA Route
Sequence / UTR
→
Plasmid Template
→
IVT / Capping
→
Purification
→
UF/DF
→
QC / Release
Circularization & IP
Multiple Circularization Strategies
T4 ligase, Group I intron, and Group II intron circularization routes are supported to match different circRNA sequence designs, process requirements, and development stages, with partner-supported proprietary circularization IP licensing options available for selected programs.
Process Design
One-Pot & Two-Step Process Development
Flexible one-pot and two-step workflows support IVT, circularization, template digestion, chromatography, UF/DF, and filtration based on product characteristics and scale-up needs.
Purification
circRNA Purity & Impurity Clearance
Chromatography-based purification strategies support removal of linear RNA, introns, precursors, residual template, proteins, and other process-related impurities.
Nicked RNA Control
Nicked RNA Detection & Reduction
Dedicated RP-HPLC methods enable nicked RNA detection that may not be resolved by CE, supporting process optimization, purity assessment, and robust circRNA quality control.
Evidence Snapshot
Circularization IP
3 Strategies + IP
Circularization strategies with partner-supported proprietary IP licensing options.
Purity Improvement
74% → 96%
Purity improvement after chromatography-based purification.
Nicked RNA Detection
2 RP-HPLC Methods
Dedicated methods developed for nicked RNA detection.
GMP Capability
10mg-30g
GMP circRNA drug substance manufacturing capability.
circRNA Route
Sequence / Template
→
IVT / Circularization
→
Template Digestion
→
Purification
→
Nicked RNA Control
→
QC / Release
Modality-Specific RNA DS Analytical Control
CATUG applies orthogonal analytical strategies tailored to each RNA modality, covering capping, poly(A), dsRNA and residual impurity control for linear RNA, and circularization confirmation, junction verification, linear RNA clearance, and nicked RNA detection for circRNA.
Stage-Appropriate RNA CMC Services
From early construct design and IVT process development to GMP RNA drug substance manufacturing and clinical-to-commercial CMC support, CATUG provides phase-appropriate service modules for linear RNA and circRNA programs.
01
Sequence & Construct Optimization
RNA sequence optimization, proprietary UTR selection, ORF / construct design support, and circRNA construct design to improve expression potential, IVT performance, and manufacturability.
02
Template & Upstream System Preparation
Plasmid template preparation, stable backbone selection, competent cell system screening, linearization strategy, and template QC for robust IVT input control.
03
IVT Process Development & dsRNA Control
Critical raw material screening, IVT DOE optimization, reaction condition development, yield / integrity optimization, and upstream dsRNA reduction strategies.
04
Capping / Circularization Development
Enzymatic or co-transcriptional capping for linear RNA; T4 ligase, Group I intron, and Group II intron circularization routes for circRNA programs.
05
Purification, UF/DF & Impurity Clearance
Chromatography, TFF / UFDF, impurity clearance, concentration, buffer exchange, formulation optimization, and post-IVT dsRNA / residual impurity reduction.
06
RNA DS Analytical Development
Identity, purity, capping efficiency, poly(A), dsRNA, residual DNA / NTP / protein, endotoxin, bioburden, potency, and circRNA-specific analytics including circularization and nicked RNA control.
07
GMP RNA DS Manufacturing — Clinical to Commercial
GMP mRNA, saRNA, and circRNA drug substance manufacturing from 100 mg to 100 g scale, supporting early clinical, IND-enabling, later-stage, and commercial-readiness needs with LNP-ready handoff.
08
CMC Documentation, IND & Lifecycle Support
Batch records, release reports, method summaries, process descriptions, comparability support, IND-enabling CMC documentation, and later-stage lifecycle / process characterization support.
Customized RNA CMC Packages for Different Development Stages
Service modules can be combined into a customized RNA CMC package based on modality, development stage, dsRNA / impurity control strategy, batch scale, regulatory pathway, and clinical-to-commercial manufacturing needs.
GMP RNA DS Manufacturing & Tech Transfer Readiness
1 × PCV / IIT IVT Line: 100 mg–1 g 1 × 2 L IVT Line: 100 mg–10 g 1 × 20 L IVT Line: 1 g–100 g RNA DS Ready for LNP Formulation
Explore CATUG GMP Facilities
Take a closer look at CATUG’s GMP suites, RNA drug substance manufacturing setup, quality systems, and technology transfer readiness.
Flexible GMP Manufacturing Configuration
CATUG configures GMP RNA DS manufacturing across one PCV / IIT IVT line, one 2 L IVT line, and one 20 L IVT line, supporting 100 mg small-batch supply through 100 g scale-up based on modality, dose, clinical stage, and supply strategy.
Application-Driven Scale-Up Strategy
Small, fast-turnaround GMP batches support personalized cancer vaccine and IIT programs, while larger-scale IVT strategies support protein replacement, gene editing, infectious disease vaccines, RNA DS ready for LNP formulation, and later-stage clinical-to-commercial supply needs.
Differentiated circRNA GMP Capability
CATUG supports circRNA GMP drug substance manufacturing with multiple circularization strategies, circRNA-specific purification, nicked RNA control, and release analytics to advance circRNA programs from process development to GMP manufacturing.
BLA
Tech Transfer & Commercial Readiness
CATUG supports release testing, dsRNA / impurity control, batch records, analytical method transfer, process handover, comparability, IND-enabling CMC packages, and later-stage lifecycle support.
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