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Lipid Nanoparticle
A delivery system for oligonucleotide and nucleic acid payloads, with the lipids made in-house.
What the platform solves
Lipid nanoparticles are a delivery system for oligonucleotide drugs, addressing protection against serum nucleases, immune response, and targeting of a specific cell or tissue.
The platform features a novel multi-channel micro-mixer, which is what gives it scalability and reproducibility. Lipid nanoparticles with various assembly structures are built by developing the formulation and controlling the process.
End to end, including the lipids
The platform is end-to-end: CMC development and manufacturing for drug substance, drug product, and analytical support in one place.
Synthesis and manufacture of oligonucleotides and of specific functional lipids, including ionizable and PEGylated lipids, are provided in-house. That removes the usual dependency on an external lipid supplier.
R&D laboratory
The LNP R&D laboratory is at Shanghai Waigaoqiao, equipped with a multi-channel micro-mixing system, tangential flow filtration at several scales, sterile filtration, and analytical equipment. Other mixing technologies are available: MIVM, microfluidics, Precision Nano System, and LNP extrusion.
Feasibility studies, formulation development, and process development run here.
GMP manufacturing
The modular LNP manufacturing plant at Wuxi City integrates a multi-channel chip, micro-mixer system and complex preparation system into a multi-channel micro-mixer core platform, with advantages in drug loading, particle size control, and encapsulation efficiency. The modular design serves scales from 10 to 50 L per batch.
Analytical QC and QA teams supporting the process are also at Wuxi City. A project moves from R&D to GMP clinical and commercial manufacture on the same platform.
Analytical support
Analytical method development and validation, in-process control and release, raw material, excipient and packaging release, extractable and leachable compatibility studies, and ICH-compliant stability studies.