Optimising vaccine adjuvant filtration


Oil-in-water and liposome adjuvants that increase the immune system’s response to the antigen in vaccines have become more common in vaccine formulations in the last decade. They modulate the immune system in different ways than the classic aluminium salt-based immunoenhancers, making them useful in a variety of indications for which alum is ineffective. However, during sterile filtration of such oily streams, viscosity can reduce filter capacity, flux and the removal of bacteria. Finding the optimal filter is dependent on a multitude of factors. EuroBiotechNews spoke with Dr. Christina Carbrello from leading filtration specialist Millipore Corp. (Billerica) about the challenges inherent in the process, and finding the right balance between capacity and retention.

How have adjuvants in vaccine formulations changed since they were first rolled out in the 1930s?

Within the past 15 years, we have seen more adjuvants coming out that are not aluminium-based and that have novel formulations, such as oil-in-water emulsions and liposomes, which present new filtration challenges.

What challenges did you encounter

with oil-in-water or liposome formulations of adjuvants in the filtration pro­cess?

We see that these types of streams have a high concentration of particles and are therefore very challenging for capa­city, and due to the oily component, they do not behave like an aqueous stream. Often capacity and bacterial retention are balanced. So if you try to optimise the capacity, you need to be very careful to make sure that you are still main­taining robust retention across the expected range of processing conditions.

You have carried out some studies examining which factors determine capacity vs. bacterial retention…

We found a number of factors that impact filtration of these streams, including membrane structure such as pore size or asymmetry, stream properties such as viscosity, particle size and load, or filter train resistance, as well as considerations like temperature, pressure and particle features. As a result, we recommend that careful screening studies be done to understand the factors that interact for a given process stream.

Which kinds of membrane structures offer the best performance against fouling while ensuring robust retention of bacteria?

The optimal structure is highly dependent on these interacting conditions, and is very dependent on the characteristics of the process stream. Millipore helps its customers on filter evaluation case-by-case and focuses on optimising capacity with robust bacterial retention.
What kind of further research is needed to optimise filters for oil-in-water or liposome-based adjuvants?

I think these systems are very complex and further research will certainly provide new insights. Filtration can be optimised by understanding very early in the individual process which variables are likely to impact capacity and retention.B



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