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Lipid Nanoparticle (LNP) Encapsulation

Microfluidic LNP formulation for siRNA, ASO, and mRNA. We tune FRR/TFR, composition, and buffer exchange to deliver high EE%, controlled particle size/PDI, and ISO-aligned QC.

Microfluidic Mixing High EE% DLS Size & PDI Sterility • Endotoxin RUO → GMP-like

LNP Encapsulation — Overview & Service at a Glance

Bio-Synthesis, Inc. offers end-to-end lipid nanoparticle (LNP) encapsulation services for siRNA, antisense oligonucleotides (ASO, incl. LNA/cEt), and mRNA payloads. Using precision microfluidic mixing, our scientists optimize FRR/TFR and lipid composition (ionizable lipid, DSPC, cholesterol, PEG-lipid) to achieve reproducible particle size, narrow PDI, and high encapsulation efficiency (EE%).

Each project is executed within our ISO 9001 / 13485-aligned quality framework with full traceability and release testing. Typical QC includes DLS size/PDI, EE% (RiboGreen), zeta potential, pH/osmolality, endotoxin/bioburden, residual solvent, and appearance. Formulations can be exchanged into your preferred buffer via TFF or dialysis and scaled from feasibility to GMP-like production.

Modalities
siRNA • ASO • mRNA
Size Targets
60–120 nm; PDI ≤ 0.20
QC
DLS • EE% • Zeta • LAL
Supply
RUO → GMP-like

Also ask for lipid nanoparticle formulation, siRNA LNP, mRNA encapsulation, microfluidic LNP mixing, TFF buffer exchange, Bio-Synthesis LNP manufacturing.

Key Specifications
  • Modalities: siRNA • ASO • mRNA
  • Size Range: 60–120 nm (typical PDI ≤ 0.20)
  • Encapsulation Efficiency: ≥ 85% (program-dependent)
  • QC Panel: DLS, EE%, zeta, sterility/endotoxin, residual solvent
  • Supply Format: RUO → GMP-like with audit-ready documentation
Service Highlights
  • Microfluidic precision: reproducible FRR/TFR control for uniform LNPs
  • Comprehensive analytics: DLS, EE%, LC-MS (as applicable), stability tracking
  • Flexible formulation: custom lipid ratios, buffers, and nucleic-acid chemistries
  • Scalable manufacturing: feasibility → DoE → pilot → GMP-like lots
  • Full documentation: batch records, COA, QC reports, and chain-of-custody traceability

Process & Parameters

Process Flow
  1. Define payload, dose, target size/PDI, and release tests
  2. Formulate via precision microfluidic mixing (optimize FRR/TFR) into citrate buffer
  3. Purify/Exchange into final buffer (e.g., PBS) using TFF or dialysis
  4. Polish by 0.22 μm sterile filtration and fill-finish
  5. Test & Report EE%, DLS size/PDI, zeta, pH/osmolality, residual solvent, endotoxin/bioburden
Formulation Parameters
  • Flow Ratio: FRR (aqueous : organic) and TFR tuned for size/PDI
  • Composition: Ionizable lipid, DSPC, cholesterol, PEG-lipid
  • Nucleic Acid Ratio: N:P (or N:L) for high EE% with minimal free payload
  • Buffer: Citrate pH ≈ 4 → exchange to PBS or custom formulation
  • Storage: 2–8 °C (siRNA/ASO LNP) • −20 to −80 °C (mRNA LNP)

QC & Example Specs

Attribute Typical Spec Method
Particle Size 80 ± 20 nm DLS (Z-avg)
PDI ≤ 0.20 DLS
Encapsulation Efficiency ≥ 85% (program-dependent) Dye exclusion (e.g., RiboGreen)
Zeta Potential Report Electrophoretic light scattering
pH / Osmolality Report / target range pH meter / osmometer
Residual Solvent Meets limits GC
Endotoxin ≤ 0.5 EU/mL LAL
Bioburden / Sterility Meets acceptance USP tests
Appearance No visible particulates Visual

Specifications are examples; final release criteria set per modality, dose, and regulatory context.

Ordering Checklist (LNP)

  • ✅ Modality & dose — siRNA, ASO, or mRNA; target dose/volume.
  • ✅ Target size/PDI — e.g., 80 nm, PDI ≤ 0.20.
  • ✅ EE% goal — e.g., ≥ 85% with minimal free payload.
  • ✅ Buffer system — formulation buffer and final buffer requirements.
  • ✅ QC & release — DLS, EE%, zeta, sterility/endotoxin, residual solvent.
Speak to a Scientist

FAQ

Which payloads do you support?

siRNA, ASO (incl. LNA/cEt), and mRNA/saRNA. CRISPR (gRNA/mRNA) by program.

How do you control size and PDI?

We optimize FRR/TFR, composition, and buffer conditions during microfluidic mixing, then exchange/polish to the final buffer via TFF/dialysis.

What QC data are provided?

DLS size/PDI, EE% (dye exclusion), zeta, pH/osmolality, endotoxin/bioburden, residual solvent, and appearance; stability support available.

Can you support regulated workflows?

Yes. We offer RUO → GMP-like pathways with ISO-aligned QC and audit-ready documentation.

Request an LNP Formulation Plan

Tell us about your payload, target size/PDI, and intended use — we’ll propose a phased plan with timelines and QC..

Full Name *
Email *
Company / Institution *
Phone *
Target Size (nm)
EE% Goal
Modality
Notes (sequence chemistry, buffer, dose, FRR/TFR constraints, release tests)

By submitting, you agree to be contacted regarding your request.

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References

  1. mRNA LNP design & advances — Nature Rev. Materials (2021)
  2. Ionizable lipid design for siRNA LNPs — Nature Biotech (2010)
  3. Microfluidic mixing controls liposome/LNP size — Jahn et al., 2010
  4. Early microfluidic vesicle assembly — JACS (2004)
  5. DLS sizing & PDI standard — ISO 22412:2017 (PDF)
  6. RiboGreen assay for EE%/free RNA — Thermo Fisher kit page; Protocol (PDF)
  7. Microfluidic hydrodynamic focusing overview — Micromachines (2016)
  8. Historical perspective (Cullis interview) — Nat. Rev. Materials (2021)

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Greetings Researchers,

Please be advised that any information, guidelines, writeups, and oral/video/graphic content on our website are intended solely as general guidelines.
It is the researcher's sole responsibility to conduct thorough research on the designs of the products intended for their experiments before submitting
their designs to Biosynthesis for review of production feasibility.
Thank you for your understanding.

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