Services
Services Overview
Integrated One-Stop CRO & CDMO Solutions for RNA-LNP Therapeutics
CATUG provides an integrated one-stop service platform covering plasmid DNA, RNA drug substance, LNP and targeted LNP drug product, analytical development, QC testing, GMP manufacturing, and CMC support. From ready-to-use catalog products to fully customized GMP programs, CATUG provides the right execution path based on project complexity, material grade, timeline, and CMC requirements.
Biotech-Friendly
Flexible entry points, fast technical response, and practical support from early feasibility to IND-enabling CMC.
MNC-Reliable
GMP-oriented execution, QA/QC discipline, documentation support, and regulatory-aligned project management.
Conflict-Free & IP-Safe
CATUG does not take equity in client pipelines, claim downstream product rights, or develop competing drug programs.
Ready-to-Use Research Tools
Catalog Products for Early Feasibility Studies
Standardized research tools for reporter assays, delivery screening, platform evaluation, and early feasibility studies, available through a fast quote-and-shipment pathway.
Core CRO
→
CRO Services
For discovery, feasibility, screening, and preclinical development.
Discovery & screening
- Plasmid preparation
- Sequence optimization and screening
- RNA synthesis and construct feasibility
Delivery & preclinical support
- LNP formulation and lipid screening
- In vitro assay
- In vivo assay partner-enabled
- Early CMC risk assessment
Core CDMO
→
CDMO Services
For feasibility, IND-enabling, GMP manufacturing, and clinical supply.
GMP manufacturing
- Feasibility study across key CMC steps
- GMP plasmid DNA and RNA drug substance
- GMP RNA-LNP and targeted LNP drug product
- Nanobody / targeting ligand GMP support
Drug product & CMC support
- Sterile filtration, GMP fill-finish, lyophilization and standalone DP filling support
- Release testing and stability study
- CMC documentation support
Modular Support
→
Modular & Partner-Enabled Services
For standalone needs and ecosystem-supported advanced therapy programs.
Standalone modules
- Standalone analytical testing and CMC modules
- Cell banking support
- Standalone sterile fill-finish & lyophilization
- Peptide / fusion protein and targeting ligand support
Partner-enabled studies
- In vivo assay partner-enabled
- Tox study partner-enabled
- Clinical study partner-enabled
- Technology access support
One-Stop Coverage
Stage-Appropriate CMC Services Across the Full RNA-LNP Lifecycle
CATUG supports nucleic acid therapeutic programs from early research and process development to analytical control, GMP manufacturing, fill-finish, release, stability, regulatory support, and commercial readiness.
Clients can engage CATUG by individual service module or through an integrated DNA–RNA–LNP–GMP CMC package.
From Early R&D to Commercial Manufacturing
CATUG connects platform research, process development, analytical development, and GMP manufacturing standards into one coordinated project framework.
Plasmid DNA
RNA DS
LNP / tLNP DP
GMP Manufacturing
QC Release
CMC Support
CMC Risk Reduction
How One-Stop Execution Reduces CMC Risk
For RNA-LNP programs, CMC risk often comes from fragmented suppliers, immature processes, analytical gaps, timeline pressure, incomplete documentation, and IP concerns. CATUG’s integrated workflow connects process development, analytical development, GMP manufacturing, QC release, CMC support, and conflict-free client partnership.
One-stop execution reduces handoff risk, improves technical consistency, protects client IP, and accelerates decision-making.
01
Reduced Tech-Transfer Risk
Integrated DS, DP, analytics, and GMP planning help reduce repeated handoffs between separate vendors.
02
Better GMP Readiness
Feasibility studies, process development, and engineering batches help identify technical risks before GMP execution.
03
Analytical Consistency
Analytical methods are aligned from development to release testing, supporting consistent CMC decision-making.
04
Faster Issue Resolution
Cross-functional coordination among PD, AD, manufacturing, QC, QA, and PM teams supports faster escalation and resolution.
05
Clearer IND Pathway
Batch records, analytical reports, stability data, and process summaries are built into the project workflow.
06
IP & Conflict-of-Interest Protection
CATUG operates as a service-focused CRDMO without taking ownership in client pipelines, claiming downstream product rights, or developing competing therapeutic assets.
Project Entry Paths
Flexible Ways to Start with CATUG
From ready-to-use catalog products to standard CRO requests and fully customized GMP programs, CATUG provides the right execution pathway based on service type, project complexity, material grade, timeline, and CMC requirements.
Path 01
Catalog Products
For ready-to-use research tools and standardized materials supporting early feasibility studies, reporter assays, delivery screening, and platform evaluation.
1
Browse catalog / submit product request
2
Get quote
3
PO / order confirmation
4
QC check
5
Shipment
Path 02
Standard CRO / Modular Request
For clearly defined custom research-grade services, standalone analytical testing, plasmid preparation, RNA synthesis, or standard formulation requests.
1
Request submission
2
Technical check
3
Quote / service confirmation
4
Execution & QC check
5
Delivery / report
Path 03
Complex CRO / CDMO / GMP Program
For sequence screening, feasibility studies, LNP / tLNP optimization, IND-enabling CMC, GMP manufacturing, fill-finish, lyophilization, and integrated program execution.
1
Requirement assessment
2
Proposal & scope alignment
3
Feasibility / process development
4
Engineering / non-GMP batch
5
GMP manufacturing
6
QC release & CMC support
Biotech-friendly flexibility. MNC-reliable execution. Conflict-free partnership.
Simple requests move fast. Complex programs are structured. GMP programs are controlled. For urgent programs, CATUG can evaluate accelerated execution plans while clearly identifying technical, analytical, GMP, release testing, and compliance risks before project initiation.
Start a ProjectEcosystem-Enabled Solutions
Beyond Manufacturing: Technology-Enabled CMC Strategy
CATUG works with technology partners and specialized collaborators to help clients evaluate enabling technologies, select fit-for-purpose components, and design integrated CMC strategies for advanced therapy programs.
01
Proprietary Gene Editing Tool Selection
Support clients in evaluating next-generation gene editing tools and matching delivery strategies with program needs.
- Cas12-based tools
- Compact editors
- Writing editors
- Novel nucleases
- Delivery feasibility
02
Lipid & Delivery Technology Access
Help clients evaluate ionizable lipids, proprietary lipid options, and formulation strategies for RNA-LNP applications.
- Lipid selection
- Proprietary lipid access
- Formulation screening
- Targeted delivery strategy
03
circRNA Technology Enablement
Support circRNA programs through RNA design, process feasibility, analytical development, and partner-enabled access.
- circRNA feasibility
- Process development
- Analytical strategy
- Technology collaboration
04
Targeting Ligands & Advanced Components
Support targeted delivery programs with access to peptide, nanobody, fusion protein, and targeting component resources.
- Nanobody ligand
- Peptide ligand
- Fusion protein support
- tLNP conjugation strategy
Partner-enabled, not overpromised.
Ecosystem capabilities are introduced when they fit the client’s program strategy, technical feasibility, development stage, and CMC execution requirements.
Timeline & Client Concerns
Plan Timelines with Clear Technical Assumptions
Project timelines vary depending on molecule complexity, material grade, analytical scope, batch scale, quality requirements, and regulatory objectives. The following ranges are provided for general planning purposes.
Typical Project Timeline
| Project Type | Typical Timeline |
|---|---|
| Catalog RNA research tools | Fast quote / shipment |
| Research-grade mRNA synthesis | 1–3 weeks |
| Research-grade LNP formulation | 1–3 weeks |
| RNA-LNP feasibility study | 3–6 weeks |
| Targeted LNP feasibility study | 6–10 weeks |
| Non-GMP plasmid manufacturing | 3–6 weeks |
| GMP plasmid manufacturing | 8–14 weeks |
| GMP RNA drug substance | 8–12 weeks |
| GMP RNA-LNP drug product | 10–16 weeks |
| IND-enabling CMC package | 4–8 months |
For urgent programs, CATUG can evaluate accelerated execution plans while clearly identifying technical, analytical, GMP, release testing, and compliance risks before project initiation.
Key Client Concerns We Address
Can CATUG support my specific RNA-LNP modality?
CATUG supports a broad range of nucleic acid therapeutic modalities, including mRNA, circRNA, saRNA, gRNA / sgRNA, plasmid DNA, RNA-LNP, and targeted LNP systems.
What if my process is not ready for GMP?
CATUG can support feasibility studies, process development, analytical method development, engineering batches, and GMP readiness assessment before initiating GMP manufacturing.
How fast can CATUG deliver?
Standard catalog products and defined CRO requests move quickly through quote and delivery. Complex or GMP programs require scope alignment and technical risk assessment.
Can CATUG support IND-enabling CMC?
CATUG supports process development, analytical development, GMP manufacturing, release testing, stability study, batch documentation, and CMC documentation support.
How is project communication managed?
Projects are managed through defined milestones, regular technical updates, issue escalation, and coordination among PM, process development, analytical, manufacturing, QC, and QA teams.
Project Experience & Case Studies
Representative Project Experience
CATUG has supported RNA-LNP programs across discovery, preclinical, IND-enabling, and GMP manufacturing stages. Explore selected case studies and platform materials to understand how CATUG supports complex nucleic acid therapeutic programs.
Case Study 01
Integrated RNA-LNP Formulation and Scale-Up Case
Client need
RNA-LNP formulation and scalable encapsulation strategy for development-to-GMP translation.
CATUG solution
MaxMix-enabled process development, formulation optimization, encapsulation scale-up, analytical testing, and GMP readiness support.
Key value
Supported process scalability and reduced RNA-LNP drug product tech-transfer risk.
Case Study 02
circRNA CMC Development Case
Client need
circRNA development support covering process feasibility, analytical strategy, and manufacturing-oriented CMC execution.
CATUG solution
circRNA design support, process development, analytical characterization, quality assessment, and development-stage CMC planning.
Key value
Enabled technical decision-making for circRNA manufacturing and quality control strategy.
Catalog Resource
Ready-to-Use RNA Research Tools Catalog
Client need
Fast access to standardized RNA research tools for reporter assays, delivery screening, and early feasibility evaluation.
CATUG solution
Catalog products covering reporter mRNA, circRNA tools, saRNA tools, fluorescent-labeled RNA, and other early-stage research materials.
Key value
Supports fast quote-and-shipment execution for early feasibility and platform evaluation.
Platform Resource
One-Stop CRDMO Service Platform
Client need
Integrated support across plasmid DNA, RNA drug substance, LNP drug product, analytical development, GMP manufacturing, and CMC documentation.
CATUG solution
One-stop CRDMO execution from feasibility and process development to GMP production, QC release, and CMC support.
Key value
Reduces multi-vendor coordination and supports consistent CMC execution across DS and DP.
Talk to CATUG About Your RNA-LNP Program
Whether you need catalog research tools, a standard CRO request, feasibility studies, GMP manufacturing, or an integrated IND-enabling CMC package, CATUG can help define the right execution pathway.
Contact Us
ICH FDA EMA NMPA
contact us