Vaccine Adjuvant Production

Adjuvants are ingredients added to a vaccine to help induce a more potent immune response and improve the efficacy of a vaccine.  They can also serve to reduce the amount of antigen needed in the production of the vaccine, enabling more treatments to be manufactured.

The original adjuvants were insoluble aluminium salts (alum) which were commercially used in many well-known vaccines.  However, alum is not an effective adjuvant in every case - so other options were investigated.

The response was to create the now commonly used adjuvants which are oil-in-water emulsions such as MF59 (Novartis) and adjuvant systems 03 (AS03 from GSK), both have been used in seasonal flu vaccines as well as pandemic influenza vaccines.

Microfluidizer^® high shear processors have been used for decades to manufacture nanoemulsion adjuvants. 

Microfluidizer^® technology combines a fixed geometry Interaction Chamber^TM 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.

Results are repeatable and scalable from lab to production scale. Parallel arrangements of identical microchannels ensure linear scalability.  Large volumes can be produced at tens of liters per minute at the same particle size and PSD as achieved in the lab.

Customers using Microfluidizer^® processor technology for vaccine development find that it is easy to use and produces reliable results.

Microfluidics machines produce stable nanoemulsions which enable post process sterile filtration to be more easily conducted. 

The Microfluidizer^® processor has been shown to produce up to 55% smaller emulsions with the same energy input of alternative methods. In addition, these emulsions were less polydisperse.

In tests, the Microfluidizer^® processor consumed less power than alternative manufacturing methods as fewer passes were needed to achieve the target particle size and at a lower pressure.  

MF 59 was the first squalene-based, oil-in-water emulsion which was licensed and commercialized by Novartis for adding to their influenza vaccines.

It has been licensed around the world and has been shown to have a significant impact on the immunogenicity of pandemic influenza vaccines.

MF59 has been licensed in Europe for pandemic flu vaccines and used for H1N1 pandemic flu vaccine in 2009 (Clark et al., 2009)