for Lipid Nanoparticles (LNP)

They ensure antigens are released to the desired organs in the body and prevent uptake by Mononuclear phagocyte system (MPS).

Two approaches are commonly used when using LNPs to deliver DNA or RNA molecules - the in-situ encapsulation approach or post adsorption approach.

The former tries to incorporate DNAs or RNAs while forming the nanoparticles. A drawback is poor encapsulation efficiency and potentially reduced release rate will offset the rapid-response nature of vaccines. Furthermore, stockpiling of these DNA/RNA vaccines may not be feasible due to stability and scalability limits and hence impact readiness in response to pandemics.

The latter allows manufacturing and storing of the nanoparticle delivery systems separately from the target DNA/RNA, which are then combined prior to vaccine administration. This two-step approach is a good alternative way and ideal in responding a pandemic situation, because the LNPs can be stockpiled and only the DNA/RNA would need to be produced after the pandemic began. 

The most common technique is demonstrated here in this 5 step process:

Step 1: The phospholipid, carrier oil and any hydrophobic actives are dissolved in a solvent. This solvent is then removed via evaporation - either by a rotor-stator at the lab-scale or by spray-drying on the production scale.

Steps 2 and 3: A buffer is added to the resulting precipitate from Step 1 and warmed and vortexed to hydrate the phospholipids.

Step 4: The antigen (or other hydrophilic actives) is added to the solution whereby large multi-layer vesicles (MLVs) are generated.

Step 5: The MLVs are processed through a Microfluidics Processor to reduce their size to small uni-lamellar vesicles.

Ref: University of Strathclyde research

Customers using Microfluidizer^® processor technology for Lipid Nanoparticle applications achieve differentiation from lab on chip technology with:

Microfluidizer technology enabled a pharmaceutical company to successfully create the appropriate nanoparticles, which were in fact liposomes, that were designed to treat carcinomas.

Small and uniform particles
The average particle size was reduced to around 40 nm. The polydisperse index (PdI) was less than 0.1, which indicates high particle size uniformity.

Scalability
The process was scaled up directly from lab scale to the production scale under the same conditions. The results obtained from the production machine was almost identical to the results produced by the lab machine.

If you would like advice on how to scale up your Lipid Nanoparticle formulation, please schedule a demo or lab test where we will be able to help you and prove the success of the Microfluidics technology.

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