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Vaccines have been vital in the fight against the global pandemic of Covid-19. The search for a solution and the need to vaccinate millions of people means that a robust large-scale production solution needed to be found.
Vaccines have existed for over 100 years, they began as injections of similar viruses – these days native viruses are either ‘inactivated’, which are grown in chicken eggs and then killed with radiation, or ‘attenuated’ meaning that their activity has been reduced as to not infect the recipient, but the body will still recognize the intrusion and create antibodies.
The second generation uses recombinant protein-based solutions. Rather than introduce the entire virus to the patient, a protein – most commonly the spike protein - is isolated and used. Here a vaccine adjuvant is vital to enhance not only the efficacy of the vaccine but also to improve the number of dose treatments that can be manufactured from each batch.
The more recent, third generation of vaccines utilize nucleic acid-based vectors such as DNA or RNA. It codes the protein – the body generates the protein itself. The scale and infrastructure needed for this type of vaccine are not yet well developed. This has accelerated the need for suitable drug delivery systems. Various lipid-based nanoparticle platforms including Liposomes are being investigated as the most promising approach.
Microfluidizer® high shear processing technology combines a fixed geometry Interaction ChamberTM and a constant pressure intensifier pump which means that virtually the entire batch is passed through the Microfluidizer® processor at the required shear rate. This results in small particle sizes with a narrow size distribution.
Microfluidics offers Benchtop, Pilot Scale and full production scale equipment that is suitable for vaccine development and production. The results obtained in the lab are guaranteed on scale up as the same size and shape of microchannel Interaction ChambersTM are used on the production units to match that of the lab - they are added in parallel to deliver scale-up.
Research has proved that the particle size distribution (PSD) achieved in the lab in batch sizes of 300mL/minute can be replicated at a production scale with volumes of 5 L/minute.
Tests have shown the technology creates best-in-class stable nanoemulsions that can be sterile filtered to avoid the need for costly aseptic processing. The technology produces oil droplet sizes of d90 < 200 nm which are effective for sterile filtration. If the particles are too large they will cause a loss of product and require more expensive filtration equipment downstream.
Microfluidics is proud to have collaborated over the years with leading research institutes around the world.
Watch the webinar we co-hosted with IDRI (Infectious Disease Research Institute) where Dr. Chris Fox talks about their vaccine and adjuvant development and explains how their R&D technology was transferred to production scale processes and used in pandemic flu responses.
Microfluidics has worked with Dr. Yvonne Perrie from the University of Strathclyde to develop liposomal formulations for RNA vaccines as well as various other lipid-based nanoparticles such as solid lipid nanoparticles (ASNs) and lipid nanoparticles (LNPs).
Read the paper to find out more.
For an introduction to how Microfluidizer® Technology is used for creating RNA vaccine delivery systems, please download our application note by clicking the button below.