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Vaccine adjuvants are critical in improving the effectiveness of vaccines. Adjuvants are ingredients added to a vaccine to help induce a stronger immune response and improve the efficacy of a vaccine. Adjuvants can also serve to reduce the amount of antigen needed in the production of the vaccine, enabling more treatments to be manufactured.
Find out how we help manufacturers achieve sterile vaccine adjuvants.
All vaccines need to be sterile - this is achieved by sterile filtration of the adjuvant nanoemulsion or the whole process is conducted in a sterile environment. Both of these incur challenges and costs.
Creating a nanoemulsion with a precise distribution curve and droplet size is challenging but will affect the ease with which the emulsion can be sterile filtered.
Microfluidizer® technology produces precisely controlled droplet sizes and distribution curves. This creates nanoemulsions that can be successfully sterile filtered even at high volume throughputs with minimal yield losses.
Adjuvants results are seamlessly and linearly reproduced to production scale levels from benchtop Microfluidics equipment.
Microfluidics equipment has successfully been used for decades in the manufacturing of nanoemulsion adjuvants. With the same energy input, it produces 55% smaller emulsions compared to other techniques.
Vaccine adjuvants are critical in improving the effectiveness of vaccines. 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.
The key to creating a successful vaccine adjuvant is precisely controlling the droplet size and the distribution curve as this determines the stability of the nanoemulsion and affects the ease with which the emulsion can be sterile filtered. As most adjuvanted vaccines are administered through injections, they must be sterile. In the manufacturing process, either the emulsified adjuvant is sterilized or the whole manufacturing process has to take place in a sterile environment.
Microfluidizer® high shear processors have been used for decades to manufacture nanoemulsion adjuvants. Microfluidizer® 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.
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.
It compares favorably to the use of High Pressure Homogenizers (HPH). These devices are commonly used for cell disruption in the lab, however, scale up can cause inconsistencies as the way the cells are ruptured changes at production scale. Multiple valves can be required, which must be cleaned and reinstalled by those with specialist training.
Users of the Microfluidizer® processors find that they are easy to use and clean. Multiple users can be comfortable with this vaccine adjuvant technology as they do not require specialist skills to use the equipment.
Propofol is used as an intravenous anesthetic and has come into wider use with the global coronavirus pandemic, as patients often require prolonged periods of mechanical ventilation and treatment of related complications that require the use of this product. Due to the surge in the use of propofol, it is currently on the FDA’s drug shortage list.
In this Application Note we look at how Microfluidizer® Technology plays a vital role in safely producing this widely used drug.
Microfluidizer® Technology can create emulsions that are 18-55% smaller than the homogenized emulsions with the same energy input. In this document we we compare the Microfluidizer processor to a High Pressure Homogenizer for the professing of a vaccine adjuvant.
Vaccine adjuvants are critical in improving the effectiveness of vaccines. 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.
The key to creating a successful vaccine adjuvant is precisely controlling the droplet size and the distribution curve as this determines the stability of the nanoemulsion and affects the ease with which the emulsion can be sterile filtered. As most adjuvanted vaccines are administered through injections, they must be sterile. In the manufacturing process, either the emulsified adjuvant is sterilized or the whole manufacturing process has to take place in a sterile environment.
MF59 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).
The process for manufacturing MF59 involves high-speed mixing into a coarse emulsion which is then passed repeatedly through a Microfluidizer® processor to produce an oil-in-water emulsion of uniform small droplet sizes (<160nm). The emulsion can then be sterile filtered and filled into vials.
Microfluidics also supply small scale lab equipment for use in research studies which is fully scalable to the production units.
Recommended downloads for manufacturers looking to achieve stable nanoemulsions.
Let our team of experts guide you through your options.