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Lipid Nanoparticle
The delivery system and the lipids that make it, in one organization.
Why LNP, and where the risk sits
Lipid nanoparticles are a delivery system for oligonucleotide drugs, and they address the delivery problems the class has: protection against serum nucleases, the immune response, and targeting a specific cell or tissue. For systemically delivered oligonucleotides that are not GalNAc-conjugated, LNP is usually the answer.
Supply of the lipids is the constraint. Ionizable and PEGylated lipids are specialist chemistry with a short supplier list and long lead times, and an LNP program dependent on a single external source carries a supply risk. We synthesize both in-house, at any scale.
An end-to-end platform
The LNP service runs from lipid discovery through formulation and process development, analytical development, and GMP clinical and commercial manufacture, with the functional lipids synthesized in the same organization. CMC development and manufacturing for drug substance, drug product and analytical support sit on one platform.
The platform features a novel multi-channel micro-mixer, which is what gives it scalability and reproducibility. Lipid nanoparticles with a range of assembly structures are achieved through formulation and process control, so a program can be scaled from R&D to GMP clinical and commercial manufacture without changing platform.
What the platform delivers
- Novel lipid design and synthesis at any scale
- Robust scalability and reproducibility, starting from 5 mL
- Small particle size, 80 to 100 nm, with a narrow polydispersity index below 0.10
- Integrated formulation development, analytical work, and in vitro and in vivo evaluation
- Flexible scale, from 10 L to 50 L per sub-batch
Sterile manufacture
The sterile LNP plant sits within the drug product network at Wuxi City, and liposomal and other nanoparticle formulations are supported on the same aseptic lines as every other injectable here — fully enclosed isolation systems, automated filling, and vials, prefilled syringes or cartridges.
The oligonucleotide and the lipid from one source
An LNP program needs the oligonucleotide, the ionizable lipid and the PEGylated lipid. All three are made at WuXi, which removes the supplier with the long lead time from the critical path and keeps one impurity discussion rather than three.
