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APPLICATIONS

Vaccine Adjuvant Production

High Shear Processors for Vaccine Adjuvant Development and Production

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.

EXPLORE:

Find out how we help manufacturers achieve sterile vaccine adjuvants.

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YOUR CHALLENGES

Creating 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.

Vaccine-Adjuvants
HOW WE CAN HELP

Technology for Vaccine Production

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.

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OUR APPROACH

High Shear Technology

Our high shear processing technology means virtually the entire batch is passed through the Microfluidizer® processor at the specific shear rate, resulting in small particle sizes with a narrow size distribution.

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OUR EXPERIENCE

Scalable 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.

BACKGROUND

Development of Vaccine Adjuvants

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.

TECHNIQUES

Technology for Vaccine Adjuvants

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.

How Our Microfluidizer Processors Work
RESOURCE

Technology for Propofol Emulsion

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.

Download the Application Note
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ADVANTAGES

Benefits of Microfluidizer® Technology for Vaccines

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

  • Results are reliably scaled from lab to production
  • Large batch sizes can be manufactured in the thousands of litres on the production-scale equipment
  • High shear processing efficiently size reduces particles with tight PSDs
  • Consistent particle size distributions are created from the ability to scale up the Interaction ChambersTM
  • The technology is cGMP approved
  • Easy to operate with low maintenance costs
APPLICATION NOTE

Producing Nanoemulsion Adjuvants

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.

Download the Brochure
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RESULTS

Proven Solutions

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.

Read the Blog for More Information
EMULSIFICATION

MF59 Emulsion

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.

BLOG ARTICLES

Expert Advice and Information

Recommended downloads for manufacturers looking to achieve stable nanoemulsions.

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Next-Generation RNA Technology & Delivery with Dr. Darrick Carter

Sep 8, 2022 2:57:43 PM

Microfluidics International was pleased to host a joint webinar with HDT Bio.,..

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Microfluidics Role in the Production of Pneumococcal Vaccines

Jan 29, 2021 4:35:13 PM

According to the World Health Organization (WHO), pneumonia is the leading..

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