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Analytical

Integrated Analytical Insight for RNA and LNP Development

Comprehensive analytical platforms enabling confident decisions across nucleic acid and nanoparticle research
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analytical service
Crystal NAX provides comprehensive analytical and characterization services to support nucleic acid and lipid nanoparticle research and development. Our services span routine analytical testing, extended and specialized characterization, custom method development and validation, and stability studies across diverse RNA and LNP systems.

Supported by a broad analytical infrastructure and experienced analytical development scientists, we apply fit-for-purpose and orthogonal analytical approaches to interrogate critical quality attributes at every stage of development. Our platform is designed to deliver high-quality, reproducible data that enables informed decision-making throughout research and preclinical programs.

Platform Advantages

  • Broad analytical coverage for nucleic acids and lipid nanoparticles
  • Routine, advanced, and specialized characterization capabilities
  • Orthogonal methods applied to each critical quality attribute
  • Custom method development and validation tailored to project needs
  • Stability study support under diverse experimental conditions
  • Data quality, reproducibility, and scientific rigor at the core
  • Experienced analytical development and characterization scientists
Bio-inert HPLC platform for reproducible analysis of sensitive protein and peptide samples
Agilent 1260 1290 infinity II bio inert
High-resolution LC-MS QTOF system for intact mass analysis and impurity profiling of biologics
Agilent LCMS QTOF
Automated fragment analysis system for nucleic acid sizing and quality assessment
Agilent FA 5300
Capillary electrophoresis SDS platform for protein purity and size variant analysis
Sciex CE SDS
FTIR spectrometer with ATR for structural and compositional analysis of biomolecules
Shimadzu FTIR spectrometer
Real-time PCR platform for quantitative detection and analysis of nucleic acids
Real Time PCR
Flow cytometry system for multiparametric analysis of cells and complex biological samples
Flow Cytometer
Ultra-high-performance liquid chromatography system for high-resolution characterization of biologics and complex biomolecules
Thermo Vanquish UPLC
Automated plate washing system for high-throughput immunoassays and bioanalytical workflows
Plate washer
Multimode microplate reader for absorbance, fluorescence, and luminescence assays
Varioskan Plate Reader
Circular dichroism spectrometer for secondary structure and conformational analysis of biomolecules
Chirascan v100
Differential scanning calorimeter for thermal stability and unfolding analysis of proteins
TA Nano Differential Scanning Calorimeter (DSC)
Sedimentation velocity analytical ultracentrifugation system for protein size and heterogeneity analysis
Beckman sedimentation velocity analytical ultracentrifugation
Dynamic light scattering system for hydrodynamic size and aggregation measurements of biomolecules
Dynamic Light Scattering
Flow imaging microscopy system for particle size, morphology, and aggregation analysis in biologics
Flowcam 8100
Biolayer interferometry system for label-free binding kinetics and affinity characterization
Octet Red 96e Biolayer interferometry
Optical microscope for morphological inspection and qualitative analysis of biological samples
Optical Microscope

Current Platform Methods for RNA and LNP Analysis

# Test Method # Test Method
1
Appearance
USP <790>
14
Poly(A) Distribution
LCMS
2
pH
USP <791>
15
Aggregates
SEC-HPLC
3
Identity
AGE
16
dsRNA
ELISA
4
Content
UV
17
Dot Blot
5
HPLC
18
Residual pDNA
qPCR
6
Extinction Coefficient
NaOH Digestion
19
Residual NTP
HPLC
7
A260/A280
UV
20
Residual Protein
Fluorescent
8
Integrity
AGE
21
Residual T7 Polymerase
ELISA
9
CE
22
Residual DNase I
ELISA
10
Purity
RPIP-HPLC
23
Endotoxin
Gel-clot
11
Capping Efficiency
HPLC
24
Photometric
12
LCMS
25
Potency
CFT
13
Poly(A) Tailed %
HPLC
26
Cell-based assay
# Test Method # Test Method
1
Appearance
USP <790>
14
RNA Integrity
Agarose Gel
2
pH
USP <791>
15
CE
3
Osmolality
USP <785>
16
CGE
4
Size & PDI
DLS
17
Lipid ID
HPLC-CAD
5
Surface Charge
Zetasizer
18
LCMS
6
EE
Fluorescence
19
Lipid Content
HPLC-CAD
7
mRNA Identity
RT-PCR
20
Lipid Impurities
HPLC-CAD
8
RNA Content
Fluorescence
21
LCMS
9
qPCR
22
Sucrose Content
HILIC-CAD
10
IEX-HPLC
23
Endotoxin
Gel-clot
11
RPIP-HPLC
24
Photometric
12
RNA Purity
RPIP-HPLC
25
Potency
CFT
13
RNA Aggregates
SEC-HPLC
26
Cell-based assay
P2d routine test Crystal Nucleic Acid X (CNAX) Analytical

Routine testing

P2d method develop Crystal Nucleic Acid X (CNAX) Analytical

Method Development

P2d Characterization Crystal Nucleic Acid X (CNAX) Analytical

Characterization

P2d stability study Crystal Nucleic Acid X (CNAX) Analytical

Stability Study

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