Targeted LNP Services

Supports efficient conjugation of antibodies against diverse targets and of various types

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Built on extensive experience in LNP delivery, Enorna's tLNP platform delivers research- and GLP-grade encapsulation services for targeted delivery of nucleic acid drugs to specific cells or tissues, empowering in vivo CAR and targeted gene editing therapies with a robust delivery tool.

Why Us
1Robust Conjugation Process

Robust conjugation processes ensure product homogeneity and process consistency

High conjugation efficiency ensures effective targeted delivery of nucleic acid therapeutics

Platform drug products have been validated for in vivo delivery in non-human primates (NHPs)

2Flexible Manufacturing Services

Supports conjugation of full-length IgG, VHH nanobodies, scFvs, and other antibody formats

Supports commercial lipids (e.g., SM102), Enorna proprietary, and customer-supplied novel lipids

From 2 mL research-grade to 1000 mL GLP-grade manufacturing, with CDMO services capable of reaching gram-scale production

3In-house NanoFCM Analytical Platform

Antibody Conjugation Efficiency

Antibody Copy Number

Empty LNP

tLNP Preparation

Enorna offers research grade & GLP-grade tLNP preparation for in vitro and in vivo assays (mouse/NHP).

 
Research Grade
GLP Grade
Antibody Options
IgG, VHH, scFv, Fab, and others
IgG, VHH, scFv, Fab, and others
Lipid Options

1)Commercial lipids

2)Enorna-recommended novel lipids

3)Customer-supplied novel lipids

1)Commercial lipids

2)Enorna-recommended novel lipids

3)Customer-supplied novel lipids

Scale
2-100 mL
100-1000 mL
Turnaround Time
5 business days
5–8 business days
Deliverables

a) RNA-tLNP

b) Report of Analysis (RoA)

a) RNA-tLNP

b) Report of Analysis (RoA)

For other custom requirements, please contact us for inquiries.

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tLNP QC Testing Items
Item
Method
Specification
Research Grade
GLP Grade
Appearance
Visual inspection
Clear, free of visible particulates
Final Concentration
RiboGreen fluorescence assay
0.05 – 0.4 mg/mL
Encapsulation Efficiency
RiboGreen fluorescence assay
> 85%
Encapsulated RNA Integrity
Bioanalyzer

<4k nt: ≥75%

>4k nt: Report value

Particle Size
Dynamic Light Scattering (DLS)

MC3-LNP 80-110 nm

SM102-LNP 65-125 nm

LP01-LNP 65-125 nm

ALC0315-LNP 50-100 nm

Polydispersity Index (PDI)
Dynamic Light Scattering (DLS)
< 0.2
Zeta Potential
Zeta sizer by DLS
± 20.0 mV
pH
pH meter
7.4 ± 0.5
Endotoxin
Semi-quantitative gel-clot method
<10 EU/ml
Microbial Limit
Direct Inoculation
No growth after 72 hours
Antibody Conjugation Efficiency
Nano-flow cytometry
Report value
Empty LNP
Nano-flow cytometry
Report value

Y

N

Optional

NanoFCM Testing & Analytical Development Services

Enorna's NanoFCM platform offers comprehensive services, including sample analysis, analytical method development, and validation.

  • Single-Particle Size and Concentration Analysis

    Particle Size

    Size Distribution Profile

    Size Standard Deviation

    Absolute Concentration (Particles/mL)

  • Nucleic Acid Localization Analysis

    Empty LNP

    Free Nucleic Acid Ratio

    Surface-Adsorbed Nucleic Acid Ratio

    Nucleic Acid Copy Number

    Encapsulation Efficiency

  • Antibody Conjugation Analysis

    Antibody Conjugation Efficiency

    Antibody Conjugation Copy Number

Compliance-Driven Complete NanoFCM Solutions

Compliance-Driven Complete NanoFCM Solutions

Development and Validation Capabilities

Full capabilities in analytical method development, validation, and transfer

Data Integrity and Reliability

User access control, electronic signatures, and audit trail functionality

Strictly Controlled Processes

Instruments undergo rigorous calibration and quality control to ensure all analyses are performed under controlled conditions

Case Studies
  • Antibody Conjugation Density

    CD8 VHH nanobody-conjugated LNP analyzed using fluorescent antigen and fluorescence-quantified microspheres, demonstrating a conjugation density of ~42.1

  • Antibody Conjugation Efficiency

    CD8 VHH nanobody-conjugated LNP assessed with fluorescent antigen, achieving a conjugation efficiency of ~94%

  • Empty LNP Rate

    Transmembrane nucleic acid dye was used to quantify empty LNPs/tLNPs, showing an empty rate of ~3.6%

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