The Significance of LNP Lipid Composition Analysis
Lipid nanoparticles (LNPs), as effective vehicles to deliver small or large RNA molecules, have successfully entered the clinic. LNP typically contains four lipid components: cationic lipid, PEG lipid, helper lipid, and cholesterol.
LNP formulation development is one of the most critical aspects of the mRNA life cycle for ensuring drug quality, efficiency and stability during manufacturing, transport, long-term storage, administration and delivery.
LNP Formulation Solutions of Yaohai Bio-Pharma
- Linear plasmid process development and optimization
- LNP process development by microfluidics device
- mRNA-LNP drug product (DP) formulation development
Methodology
Quality by Design (QbD)
Design of Experience (DoE)
One Factor at a Time (OFAT)
Service Details
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Service Details
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Unit Operations
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Parameters
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LNP Lipid Components Screening
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High-throughput formulation screening
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Lipidtype, molar lipid ratios
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LNP Process Development
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Microfluidics technology
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Molar N/P ratios, ratio of aqueous phase to ethanol phase, feed flow rate
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mRNA-LNP Formulation Development
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Lipid DP formulation screening
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Buffer compositions, pH, Ionic strength, stabilizers, surfactants, excipients,etc.
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Lyophilized DP formulation screening
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Lyoprotectant (e.g., sucrose, trehalose),buffer system, excipients,etc.
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Timeline of mRNA CDMO Solutions
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