Yaohai Bio-Pharma’s Analytical Method Development Services
Yaohai Bio-Pharma offers customized mRNA analytical development services, including the identification of plasmid, mRNA and lipid nanoparticle-mRNA (LNP-mRNA), as well as process/product-related impurities.
We provide phase-appropriate analytical method development and validation solutions. Our team has significant expertise in analytics for all stages of the biologics development lifecycle, from early-stage protocols to late-stage quality control method optimization. Tests are designed in consideration of the 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
- Method development and optimization for in-process controls, release and stability studies
- Analytical method qualification/validation
- Quality control (QC) and stability studies of research batches
- Reference standard generation and characterization
- Technology transfer to QC
Method Development and Pre-Validation:
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Quality Attribute
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Analytical Methods
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CircularPlasmid
(circPlasmid)
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Supercoiled Plasmid Percentage
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Capillary Electrophoresis-Laser-Induced Fluorescence (CE-LIF)
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Anion Exchange High-Performance Liquid Chromatography (AEX-HPLC)
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Host Cell Protein (HCP)
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Enzyme-Linked Immunosorbent Assay (ELISA)
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Host Cell DNA (HCD)
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Quantitative Polymerase Chain Reaction (qPCR)
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Residual RNA
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qPCR
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Residual Protein
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Bicinchoninic Acid Assay(BCA)
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Residual Antibiotics
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ELISA
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LinearizedPlasmid
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Linearized Plasmid Purity
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Capillary Electrophoresis (CE)
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mRNA
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mRNA Integrity
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CE, Capillary Gel Electrophoresis with Laser-Induced Fluorescence Detector (CGE-LIF)
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Product Related Impurities - Aggregates
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Size Exclusion Chromatography High Performance Liquid Chromatography (SEC-HPLC)
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Product Related Impurities - Fragment mRNA
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Reverse Phase High Performance Liquid Chromatography (RP-HPLC)
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Product Related Impurities -dsRNA
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ELISA
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mRNA Capping Efficiency
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Liquid Chromatography-Mass Spectrometry (LC-MS) After Digestion
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PolyA Distribution
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LC-MS After Digestion
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Host Cell Protein (HCP)
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ELISA
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Host Cell DNA (HCD)
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qPCR
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Residual DNA
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qPCR
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LNP-mRNA
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Lipid Component
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High Performance Liquid Chromatography with Charged Aerosol Detector (HPLC-CAD)
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Lipid Content
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HPLC-CAD
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Timeline of mRNA CDMO Solutions
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