Micropore is a technology provider with global experience in manufacturing all different types of vaccine modalities can further ensure a cost-effective, high-quality process. Partnering with Micropore will enable a stronger benchmark with in-depth expertise and the ability to leverage novel technologies will also help reduce risk and shorten timelines.

With mRNA vaccine production requiring relatively less space than other approaches, new facilities may be more feasible and affordable. Micropore technology can enable localised production of vaccines and thus accelerate access to a much larger population. In locations with limited or no infrastructure, the Micropore approach can be the shortest route to production and can reflect the exact needs of the organisation at minimal cost.

Micropore offers a minimal cost model achieved through the AXF advanced cross flow technology platform. The flexibility of mRNA-based vaccines when manufactured using this single piece of stainless steel equipment with no consumables means it requires the least capital investment. The scalability of production (from 200 μL to 1500 L/hr) reduces the facility design complexity and means that more doses can be manufactured in a continuous process which eliminates variability, compared to a batch-to-batch approach. As such, this vaccine modality combined with the Micropore mixing platform can be a robust starting point for production with low risk.

Micropore cross flow technology demonstrates predicable scalability which is favourable especially for GMP manufacturing which means process controls can be introduced that are automated – process analytical technologies (PAT). Automated analysis of properties such as online particle size enables the option to automatically control any deviations in size and feed that back to control the pumps and optimise control to give the correct size again. This increases confidence in quality of production meaning throughput can be increased further.

The determinants of stability of mRNA in LNP formulations – what parts are predicated on the payload of mRNA and what portions are predicated on the lipid nanoparticles themselves or what portions are predicated on the development technology that’s used – can be related to its size and its secondary structure. Messenger RNA poses a unique manufacturing challenge because of its large size. Other RNA entities such as siRNA and guide RNA for clustered regularly interspaced short palindromic repeats (CRISPR) technology typically are produced using chemical synthesis, which can be performed in a relatively controlled environment. But mRNAs are larger, with complex three dimensional structures that aren’t yet fully understood.

Malvern Zetasizer (DLS) enables particle size and stability measurements while the RedShiftBio Aurora (MMS) system enables secondary structure (HOS) determination.