According to the WHO, USP, and NMPA Guidelines for mRNA Vaccines, quality control (QC) of DNA templates, mRNA drug substance (DS) and lipid nanoparticle-mRNA (LNP-mRNA) drug product (DP) is recommended.
Yaohai Bio-Pharma can provide in-process control, batch-release solutions for circular and linearized plasmids, mRNA DS and finished LNP-mRNA to meet regulatory needs.
We design QC testing for appearance, identification, activity, purity and impurities, following ICH Quality guidelines, relevant pharmacopeia (EU and US monographs), regulatory guidelines (ICH, FDA and EMA) and GMP/GLP practices.
Abbreviation:
ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
FDA: Food and Drug Administration
EMA: European Medicines Agency
GMP: Good Manufacturing Practice
GLP: Good Laboratory Practice
Service Details
Quality Control of Template Plasmid
|
Category
|
Quality Attributes
|
Analytical Techniques
|
Research Grade
|
Clinical Supply
|
|
Physicochemical Property
|
Appearance, Visible Foreign Material
|
Visual
|
√
|
√
|
|
pH
|
Potential
|
√
|
√
|
|
Biochemical Property
|
DNA Concentration
|
UV/A260
|
√
|
√
|
|
Identity
|
Target Gene Sequencing
|
Sequencing
(Third Party)
|
--
|
√
|
|
Restriction Enzymes Digestion
|
Agarose Gel Electrophoresis (AGE)
|
√
|
√
|
|
Product-related Impurities
|
Superhelix Plasmid Purity or Linear Plasmid Purity
|
AGE
|
√
|
√
|
|
High-performance Liquid Chromatography (HPLC)
|
--
|
√
|
|
Capillary Electrophoresis (CE)
|
--
|
√
|
|
Process-related Impurities
|
Residual Endotoxin
|
Gel Method
|
--
|
√
|
|
Chromogenic Method
|
√
|
--
|
|
Host Cell Protein, HCP
|
Enzyme-Linked Immunosorbent Assay (ELISA)
|
--
|
√
|
|
Host Cell DNA -HCD
|
Quantitative Polymerase Chain Reaction (qPCR)
|
--
|
√
|
|
Host RNA
|
Reverse Transcription-Quantitative Polymerase Chain Reaction(RT-qPCR)
|
--
|
√
|
|
Residual Antibiotic
|
ELISA
|
--
|
√
|
|
Bioburden
|
Bioburden
|
Plate Counting, Membrane Filtration
|
--
|
√
|
|
Sterility
|
Direct Inoculation, Membrane Filtration
|
--
|
√
|
|
"√":Recommended,"--": Optional
|
Quality Control of mRNA
|
Category
|
Quality Attributes
|
Analytical Techniques
|
Research grade
|
Clinical supply
|
|
Biochemical Property
|
mRNA Concentration
|
UV/A260
|
√
|
√
|
|
mRNA Purity
|
A260/A280
|
√
|
√
|
|
Identity
|
mRNA Sequencing
|
Sequencing
(Third Party)
|
--
|
√
|
|
Structure Integrity
|
mRNA Integrity
|
CE
|
--
|
√
|
|
Capillary Gel Electrophoresis with Laser-Induced Fluorescence Detector(CGE-LIF)
|
--
|
√
|
|
AGE
|
√
|
√
|
|
mRNA Capping Efficiency
|
Liquid Chromatography-Mass Spectrometry(LC-MS)After Digestion
|
--
|
√
|
|
mRNA polyA Distribution
|
LC-MS After Digestion
|
--
|
√
|
|
Product-related Impurities
|
Aggregates
|
Size Exclusion Chromatography High Performance Liquid Chromatography(SEC-HPLC)
|
--
|
√
|
|
mRNA Fragments
|
Reverse Phase High Performance Liquid Chromatography(RP-HPLC)
|
--
|
√
|
|
dsRNA
|
ELISA
|
--
|
√
|
|
Process-related Impurities
|
Residual Endotoxin
|
Gel Method
|
√
|
√
|
|
Host Cell Protein, HCP
|
ELISA
|
--
|
√
|
|
Host Cell DNA -HCD
|
qPCR
|
--
|
√
|
|
"√":Recommended,"--": Optional
|
Quality Control of LNP
|
Category
|
Quality Attributes
|
Analytical Techniques
|
Research Grade
|
Clinical Supply
|
|
Biochemical Property
|
Encapsulation Efficiency
|
RiboGreen
|
√
|
√
|
|
Identify
|
Lipid Content
|
High Performance Liquid Chromatography with Charged Aerosol Detector(HPLC-CAD)
|
--
|
√
|
|
Physicochemical Property
|
Appearance, Visible Foreign Material
|
Visual
|
√
|
√
|
|
Insoluble Particles
|
Light Obscuration
|
√
|
√
|
|
Nanoparticle Diameter
|
Dynamic Light Scattering(DLS)
|
√
|
√
|
|
PDI, Polydispersity Index
|
DLS
|
√
|
√
|
|
Zeta Potential
|
DLS
|
√
|
√
|
|
pH
|
Potential
|
√
|
√
|
|
Osmolality
|
Freezing Point Titration
|
√
|
√
|
|
Deliverable Volume
|
Volumetric, Gravimetric
|
--
|
√
|
|
Safety
|
Residual Endotoxin
|
Gel Method
|
√
|
√
|
|
Abnormal Toxicity
|
Guinea Pigs
|
--
|
√
|
|
"√":Recommended,"--": Optional
|
Timeline of mRNA CDMO Solutions
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