mRNA Production
&
Lipid Nanoparticle (LNP) Encapsulation Platform
mRNA Production & Lipid Nanoparticle (LNP) Encapsulation Platform
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Start Bioservices is a trusted CDMO partner with the expertise and capacity to support in the process development, manufacturing and commercialization of mRNA therapies. Our services range from plasmid and in vitro transcription (IVT) to lipid nanoparticle (LNP) encapsulation and fill-finish, ensuring high quality, cost-effective and timely production.

Why Choose Us

  • High Yield
  • High Purity
  • High Capping Efficiency
  • Flexible Production Scales

Our facilities include over 4,000 m² of laboratory, manufacturing, and office spaces.

Our 3 production lines are designed for plasmid & mRNA production at flexible scales. Each suite is equipped with independent airflow to meet the cleanliness needs of customers.

We have sufficient capabilities to develop lyophilization process and to scale up to GMP manufacturing with QMS complying with US FDA CFR Title 21 & EU GMP Annex 1.

State-of-the-Art Equipment

mRNA Manufacturing Process

  • 1
    IVT Reaction
  • 2
    Ultrafiltration & Diafiltration (optional)
  • 3
    Affinity Chromatography
  • 4
    Polishing Chromatography (optional)
  • 5
    Ultrafiltration & Diafiltration
  • 6
    Lipid Nanoparticle (LNP) Encapsulation

mRNA Analysis Methods and Specifications

mRNA Analysis
Methods and
Specifications

No.AssayMethodSpecification
01AppearanceVisual InspectionClear and Colorless
02pHUSP<791>7.0-8.0 or as Requested
03Bacterial EndotoxinUSP<85>< 5 EU/mg
04SterilityUSP<71>No Growth
05mRNA Sequence IdentitySanger SequencingIdentical to Theoretical Sequence
06mRNA IntactnessCapillary Electrophoresis (CE)≥ 85% or as Requested
07mRNA ConcentrationUltraviolet Spectroscopy (UV)Target Concentration±20%
08Residual DNA TemplateqPCR≤ 1ng DNA/mg RNA
09Residual Cap AnalogueRP-HPLC≤ 10μg/mg RNA
10dsRNAELISA≤0.1%
115’ Capping EfficiencyLC-MS/RP-HPLC> 90%
123’ Poly(A) Tail LengthLC-MS/RP-HPLCTheoretical Length±20%
13Aggregate QuantitationSEC-HPLC≤10%
14Percentage of Fragment mRNARP-HPLC≤20%
15Residual T7 RNA Polymerase ContentELISA≤10ng/mg

mRNA-LNP Encapsulation Process

Aqueous
Phase mRNA

Ethanolic Phase
Lipids

Microfluidic
Mixing

mRNA-LNPs
Formulation

Dilution

Formulation Buffer

mRNA-LNP Ultrafiltration
& Diafiltration

mRNA-LNPs
Drug Product

mRNA-LNP Analysis Methods and Specifications

mRNA-LNP Analysis
Methods and
Specifications

No.AssayMethodSpecification
01AppearanceVisual InspectionWhite to off-white Suspension
02pHUSP<791>7.0-8.0 or as Requested
03Subvisible ParticlesUSP<787>

≤6000 per container (≥10 µm)；
≤600 per container (≥25 µm)

04SterilityUSP<71>No Growth
05Identity of LipidsRP-UPLC-ELSDRetention Times Consistent with References
06Lipid ContentRP-UPLC-ELSDAs Requested
07LNP SizeDynamic Light Scattering (DLS)60-150nm
08PolydispersityDynamic Light Scattering (DLS)< 0.2
09Zeta PotentialElectrophoretic Light Scattering (ELS)Target Potential±10mV or as Requested
10OsmolalityUSP<785>270~330 mOsm/kg or as Requested
11Bacterial EndotoxinUSP<85>< 10 EU/mg
12mRNA Sequence IdentitySanger SequencingIdentical to Theoretical Sequence
13Residual SolventsUSP <467>< 0.5%
14IntegrityCapillary Electrophoresis (CE)> 85% or as Requested
15RNA SizeCapillary Electrophoresis (CE)Identical to Theoretical Size
16RNA ConcentrationFluorescence-based AssayTarget Concentration±20% or as Requested
17RNA Encapsulation EfficiencyFluorescence-based Assay> 85%
18Aggregate QuantitationSEC-HPLC≤10%
19Percentage of Fragment mRNARP-HPLC≤20%
20Extractable VolumeUSP<697>NLT the Nominal Volume
21Container Closure IntegrityUSP<1207>Reported Value