Microfluidics, high shear fluid processors consistently achieve unparalleled results across a range of applications. Our team are dedicated to serving each of these applications and are regularly answering a range of questions.
In this blog, we wanted to share some of some of the common questions we are asked related to vaccine development and give you the answers that we provide.
There are three main vaccine applications that are well established using Microfluidizer processors, vaccine adjuvants, lipid nanoparticles (LNPs) and cell disruption for the production of protein antigens.
What are vaccine adjuvants?Adjuvants are ingredients added to vaccines to induce a greater immune response, increasing the effectiveness of the vaccine. Adjuvants can come in many forms including dispersions and emulsions. Some of the most effective and well proven vaccine adjuvants utilize oil-in-water nanoemulsions. An example of such are squalene based nanoemulsions, such as MF59 which is currently used for high dose flu vaccine (Fluad) and AS03 for pandemic H1N1 vaccine (Pandemrix). This nanoemulsion can be produced at production-scale using a Microfluidizer® processor.
What are lipid nanoparticles?
Lipid nanoparticles (LNPs) are one of the most advanced pharmaceutical delivery systems. Used in recombinant protein and nucleic acid-based vaccines, they deliver the antigen safely and effectively, making them a key component of modern vaccine research. They increase the circulation time in the body and can help deliver the antigen to the target site. With an average diameter of between 10 and 1000 nanometers, lipid nanoparticles are vesicles that include a lipid-based surfactant. For vaccine manufacturers, lipid nanoparticles allow a greater ability to customize the delivery system to determine the vaccine’s behavior in the body.
How does Microfluidizer® technology recover recombinant proteins for use as antigens?
Recombinant proteins may be grown in a variety of cell types, which Microfluidizer® processors can effectively rupture. Different cell types require different levels of shear, including bacterial, mammalian, plant, insect, fungi, algae and yeast cells. Microfluidics has vast experience with different cell types and can apply the correct level of shear for effective cell disruption while ensuring high protein recovery. Microfluidizer® processors are tough on cell walls/membranes, but gentle on the intracellular contents.
How can Microfluidizer® processors be used to deliver nucleic acid based vaccines (such as RNA)
There are multiple ways to deliver nucleic acid based vaccines. Two of the more promising methods are to use both viral vectors, and non-viral vectors (lipid based nanoparticles - LNPs).
Adeno associated viral vectors are one of the more commonly seen viral vectors. These vectors are often harvested from mammalian or insect cells, which can be lysed using a Microfluidizer® processor.
LNPs have several benefits in nucleic based vaccines including:
- Both hydrophilic and hydrophobic agents can be encapsulated together with high efficiency.
- The lipid nanoparticles can be coated with inert and biocompatible polymers, prolonging the liposome’s circulation half-life in the body.
- They can also be functionalized with specific ligands to change the way the vaccine behaves, and which specific cells, tissues and organs it will target.
How do you produce a sterile product for delivery by injection?
Two common methods to obtain a sterile product are to either process it in a completely sterile (aseptic) environment, or to pass the product through a sterile filter after production. Microfluidics offers both aseptic Microfluidizer® processors and technology capable of creating easily sterile filterable products.
Microfluidizer® technology has been proven to produce pharmaceutical products with virtually all particles smaller than 200 nm. This significantly reduces the size and therefore the cost of the filter.