Platforms
DNA & PlasmidPlatformsRNA Therapeutics PlatformLNP / tLNP Delivery SystemsPolymer & Other Novel Delivery SystemsProtein & Peptide Manufacturing PlatformsGMP Manufacturing & CMC Platforms
RNA-LNP & Targeted LNP Delivery Platform
An integrated LNP and targeted LNP delivery platform supporting formulation development, payload encapsulation, lipid process adaptation, tLNP conjugation, analytical characterization, and GMP scale-up for next-generation RNA and nucleic acid therapeutics.
Payload-Flexible Delivery
Formulation strategies for RNA, DNA, and RNA-combination payloads, including co-encapsulation needs such as mRNA + sgRNA.
Application-Specific Engineering
Particle size, lipid system, mixing route, stability strategy, and targeting design tailored to each therapeutic use case.
LNP Platform Proof Points
Particle Engineering
Size / PDI / EE Control
Size-smart LNP engineering with low PDI and high encapsulation efficiency for application-specific delivery.
Novel Lipid Ecosystem
Lipid Innovation & IP Access
10–20 novel lipid process experience, CATUG's 1,000+ compound lipid library, and multiple independent IP lipid platform collaborations.
Scalable Mixing Platform
MaxMix™ + PNI
CATUG proprietary MaxMix™ scalable mixing platform, combined with microfluidic systems (PNI), supports development-to-GMP translation.
Formulation Stability
-20°C / Lyophilization
Frozen storage, cryoprotectant, freeze-thaw, lyophilization, reconstitution, and size / PDI / EE stability development.
GMP-Verified Encapsulation Scale
20+g / g-level
Verified encapsulated RNA amount: 20+g for LNP and g-level for targeted LNP production.
Targeted LNP Translation
tLNP for in vivo CAR
Antibody, peptide, aptamer, and small-molecule targeting strategies for in vivo CAR and targeted RNA delivery.
LNP Technical Strengths
CATUG integrates lipid-specific process adaptation, particle-size control, high encapsulation efficiency, formulation stability development, route-specific scale-up, and tLNP conjugation control to support application-specific LNP and targeted LNP programs.
Representative LNP Process Performance
Particle Size, PDI and Encapsulation Optimization
CATUG applies formulation and process optimization to tune particle size, maintain narrow particle distribution, and achieve high encapsulation efficiency across different lipid systems, payload types, and scale-up requirements.
Representative Optimization Cases
Lipid S
mRNA · 400–500 mg
Size
72.2 → 61.2 nm
PDI
0.09 → 0.05
EE
97.1 → 98.4%
Lipid A
mRNA + sgRNA · 150–200 mg
Size
77.5 → 56.8 nm
PDI
0.05 → 0.07
EE
92.9 → 95.7%
Lipid L
mRNA + sgRNA · 150–200 mg
Size
71.9 → 56.5 nm
PDI
0.07 → 0.08
EE
97.9 → 94.9%
High EE
High encapsulation efficiency across representative lipid and payload systems.
Low PDI
Uniform particle distribution enabled by formulation and process control.
Size-smart
Particle size can be tuned for application-specific delivery and payload needs.
Lipid identities are anonymized for public presentation; exact formulation and project data remain program-specific.
LNP Process Development Workflow
From Payload Input to Analytics and Scale-Up
CATUG connects payload input assessment, lipid and formulation selection, route selection, particle engineering, downstream UF/DF, and analytical scale-up into a route-flexible LNP development workflow.
Payload
Input
Input
→
Lipid &
Formulation
Formulation
→
Route
Selection
Selection
→
Size / PDI / EE
Optimization
Optimization
→
UF/DF &
Buffer Exchange
Buffer Exchange
→
Analytics &
Scale-Up
Scale-Up
Lipid-Specific Process Development
Adaptation Across Novel Lipids
Process development for novel lipid structures, impurity profiles, adduct risks, encapsulation behavior, and application-specific delivery requirements.
Route-Specific Scale-Up
PNI or MaxMix™ Route Selection
LNP route is selected early and scaled consistently through GMP. CATUG supports microfluidic systems such as PNI and proprietary MaxMix™, with MaxMix™ offering scale-up and cost advantages for selected programs.
Multivalent Encapsulation
Co-Encapsulation for Complex Payloads
Supports single and multivalent LNP payload systems, including RNA combinations for gene editing and multi-antigen payload strategies for vaccine programs.
Formulation & Stability Development
-20°C and Lyophilized LNP
Development covers buffer, cryoprotectant, freeze-thaw, reconstitution, visible particle control, and size / PDI / EE stability.
tLNP Conjugation Control
Ligand Density and Residual Control
Supports conjugation strategy, free ligand clearance, residual mAb control, ligand density, mAb-positive percentage, and potency assays.
Process Parameter Development
From Lipid Ratio to UF/DF and Fill-Finish
Development can cover lipid composition, N/P ratio, buffer, flow ratio, hold time, dilution, TFF / UFDF, membrane loading, filtration, and fill-finish parameters.
Targeted LNP Platform for Cell-Specific RNA Delivery
Targeted LNP is a key application direction of CATUG’s LNP platform, supporting in vivo CAR, immune-cell targeting, gene editing, and ligand-enabled RNA delivery through conjugation process development, purification, scale-up, and tLNP-specific analytical control.
Strategy 1:
Direct Encapsulation
Direct Encapsulation
Suitable for small molecules and payload co-formulation strategies where direct encapsulation contributes to targeted delivery performance.
Strategy 2:
Surface Decoration
Surface Decoration
Suitable for antibodies, antibody fragments, nanobodies and peptides for immune-cell or disease-relevant cell targeting.
Strategy 3:
Post Insertion
Post Insertion
Suitable for aptamers and ligand-enabled tLNP optimization where flexible post-formulation insertion is preferred.
tLNP Conjugation Workflow
From Targeting Moiety to Potency and Analytical Control
tLNP development extends the standard LNP formulation workflow with targeting moiety selection, linker and PEG-lipid design, conjugation strategy development, free ligand clearance, ligand density control, and potency-related characterization.
Targeting
Moiety
Moiety
→
Linker /
PEG-Lipid
PEG-Lipid
→
Conjugation
Strategy
Strategy
→
Free Ligand
Clearance
Clearance
→
Ligand Density
Control
Control
→
Potency &
Analytics
Analytics
tLNP Platform Evidence
From Conjugation Feasibility to Scale-Up Readiness
CATUG supports targeted LNP development from strategy selection and conjugation chemistry to purification, residual control, targeting-moiety characterization, potency evaluation and scale-up.
Project Experience
70+
LNP conjugation and targeted LNP projects supporting cell-specific delivery development.
IIT / IND Translation
10+
IIT or IND-enabling targeted LNP projects currently ongoing.
Scale-Up Experience
g-level
Targeted LNP scale-up experience supporting engineering and GMP-oriented development.
Conjugation Chemistry
Azide-DBCO + Thiol-Maleimide
Supports widely used LNP-mAb conjugation routes for antibody, fragment and ligand-enabled tLNP development.
Purification Control
Free Ligand & Residual mAb Removal
Purification strategies support removal of free mAb, free ligand and process-related residuals to improve tLNP consistency.
tLNP Characterization
Density, Positive % and Potency
Characterization can include mAb density, mAb-positive particle percentage, binding activity and selected potency assays.
Stage-Appropriate LNP/tLNP CMC Services
From early formulation feasibility to targeted LNP conjugation, process development, characterization, scale-up and GMP-ready transfer, CATUG provides phase-appropriate CMC service modules for RNA-LNP and targeted LNP programs.
01
Payload & Application Assessment
Evaluation of RNA modality, payload length, co-encapsulation needs, delivery route, target tissue, dose level and application-specific LNP design requirements.
02
Lipid & Formulation Screening
Screening of established or novel lipid systems, lipid ratios, N/P ratio, buffer conditions and formulation composition to identify developable LNP candidates.
03
Size-Smart Process Optimization
Process optimization for particle size, PDI, encapsulation efficiency, payload integrity and formulation robustness based on delivery application and scale-up strategy.
04
Mixing Route Selection & Scale-Up
Route selection across microfluidic systems, impinging-jet / collision mixing and CATUG’s MaxMix™ platform, with scale-up strategy from screening to larger batch preparation.
05
tLNP Conjugation Development
Development of direct encapsulation, surface decoration or post-insertion strategies, including targeting-moiety selection, linker design and conjugation chemistry optimization.
06
LNP/tLNP Analytical Development
Analytical methods covering particle size, PDI, EE, zeta potential, RNA and lipid content, residual ethanol, residual mAb, mAb binding, ligand density, potency and release-related characterization.
07
GMP LNP/tLNP Manufacturing — Clinical to Commercial
GMP LNP and targeted LNP manufacturing support from engineering and toxicology batches to clinical supply, larger-scale preparation, formulation stability execution and sterile drug product readiness.
08
CMC Documentation, IND & Lifecycle Support
Process descriptions, batch records, release reports, analytical summaries, formulation development reports, comparability support, IND-enabling CMC documentation and later-stage process characterization support.
Customized LNP/tLNP CMC Packages for Different Development Stages
Service modules can be combined into customized LNP/tLNP CMC packages based on payload type, lipid system, targeting strategy, formulation stability requirement, analytical package, batch scale, GMP readiness, regulatory pathway and clinical-to-commercial development needs.
GMP LNP/tLNP Manufacturing & Tech Transfer Readiness
CATUG supports GMP-oriented LNP and targeted LNP manufacturing through multi-platform mixing capacity, route-adaptive scale-up, structured process transfer, analytical readiness and client-specific manufacturing execution.
Explore CATUG GMP Facilities
Take a closer look at CATUG’s GMP suites, LNP manufacturing setup, quality systems, scale-up infrastructure and technology transfer readiness.
Multi-Platform GMP LNP Manufacturing Configuration
CATUG configures LNP manufacturing across MaxMix-S, PNI GMP, MaxMix-M and MaxMix-L platforms, supporting 0.1–1 L PCV / IIT preparation, 0.5–20 L PNI GMP production, 2–30 L MaxMix-M GMP scale-up and 20–2000 L larger-scale LNP preparation needs.
Route-Adaptive Scale-Up Strategy
Microfluidic, PNI and MaxMix™ routes can be selected according to formulation characteristics, payload requirements, lipid system, target batch scale and development stage, supporting consistent progression from formulation development to GMP-oriented scale-up.
Client-Aligned Technology Transfer for Preferred Encapsulation Systems
For clients with preferred or existing encapsulation systems, CATUG can support technical evaluation, process transfer, comparability assessment and potential equipment introduction for customized LNP/tLNP manufacturing execution.
Structured Tech Transfer & GMP Readiness
CATUG supports process transfer, batch records, release testing, analytical method transfer, comparability evaluation, formulation stability execution and GMP documentation to advance LNP/tLNP programs toward clinical and later-stage manufacturing.
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