The delivery of genetic material for therapeutic and immunological applications has undergone a global revolution over the last years, particularly due to the BioNTech and Moderna COVID19 vaccines.
LNPs are comprised of ionisable lipids, structural lipids, cholesterol, and PEG-grafted lipids, which each serve a purpose in the particle structure. The key component is the ionisable lipid, which can hold a positive charge at lowered pH, binding to the negatively charged phosphate backbone of nucleic acid cargo to form an active rich core protected by a lipid exterior. These can be tailored for different therapeutic targets and are essential to the function and efficacy of the LNP.
The correct size, structure and loading of these nanoparticles is essential to deliver the active material. Furthermore, the formation of these LNPs is hugely affected by the mixing process – the more thorough and rapid the better. Micropore’s sterilizable stainless steel equipment, featuring 100,000+ micron scale pores, provides reproducible and thorough mixing to produce high quality LNPs with unprecedented scalability, from 1mL samples to total flow rates (TFRs) of >1L/min per membrane module.
Liposomes – spherical lipid bilayers around an aqueous cavity – are another fast-growing lipid based nanomedicine. Lipids and liposome properties can be selected to affect the rate of drug release, circulation time, target organ and more. Hydrophobic actives can be trapped in the fatty chains of the lipid bilayer, grafted onto elements on the surface or contained within the aqueous core.
Micropore’s equipment provides the same benefits to the production of liposomes – seamless scalability on an unprecedented scale, ease of use and robust GMP ready stainless-steel construction.
The customisability of the equipment in terms of pore sizes and internal geometries allow retaining pressure drops and shear conditions within the device whilst adjusting flow rates, allowing for seamless transitions to large scale production.
Micropore has significant experience with a large range of micro- and nanoparticle technologies and has worked with dozens of companies in the injectable formulation space.
Micropore offers laboratory trials ranging from brief proof of concept trials through to full development projects running from initial formulation concept to manufacturing process design.
Micropore works in close collaboration with customers to provide the ideal custom set-ups for R&D and manufacturing to fit specific quality and regulatory compliance requirements.
Presentation by Dai Hayward
(T&T Scientific University LNP conference, 6 August 2021)
At Micropore we enjoy working in partnership with our clients to solve formulation challenges and deliver the highest performing, most sustainable, most cost-effective formulated delivery systems.
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