Boosting vaccine manufacturing

The manufacturing innovations needed to accelerate vaccine development

Compressing vaccine development timelines to 100 days will require a step-change in how we manufacture vaccines.

If the world is serious about preventing pandemics, we will need a gigantic step-change in how we manufacture vaccines, especially if we are to develop vaccines against novel pathogens in 100 days. We have to make vaccines better, faster, cheaper, easier to manufacture and closer to where they will be administered, especially in resource-poor settings. 

At its core, this is an engineering challenge, and one that will be solved through innovation. Consider the huge innovations that have transformed other manufacturing processes – from the automation of car manufacturing to 3D printing of food and even organs. Why shouldn’t we see the same in vaccines? 

Need for manufacturing innovations

Getting there will require a whole series of innovations – a continuous chain rather than one single breakthrough. Some will focus on the manufacturing facilities themselves, making them smaller and portable – akin to a factory in a cargo-sized container that could be moved around the world whilst adhering to good manufacturing practice so that consistency and quality of products are maintained. This last point is critical because safety is paramount. 

Other innovations will involve automation and robotics, enabling us to manage processes remotely – from quality checks to repairs – so that manufacturing isn’t constrained by the availability of highly skilled personnel. We should also look to innovation to help remove obstacles that can lead to bottlenecks and shortages. One such obstacle is that factories differ, and machine parts differ, which limits the ability to use them interchangeably, so we need more ‘inter-operability’ of components. 

And we need to improve the efficiency at each step in the manufacturing process. One example of a specific innovation, which CEPI is supporting, is a 200-dose ‘bag’ that could replace the 200 glass vials that would be needed to deliver the same number of vaccines. The bag, roughly the size of a spectacle case, could greatly simplify the logistics of mass vaccination, taking up less space in shipments and allowing vaccinators to speed up the administration of individual shots. The end-result aims to cut out complexity, but getting there is complicated, for good reason. The plastic material that makes up the bags need to be rigorously assessed for how it interacts with vaccine product, and checked for sterility.

Incremental gains

The benefits of improving each individual step in the manufacturing process quickly add up. Consider a 5000L stainless-steel fermenter, which is used to grow the bacteria that make the antigens used in some vaccines. It requires a week to prepare, grow the bacteria, and purify the antigen. By applying innovations in fermentation technology, or in genetics to improve the efficiency with which a microbe produces an antigen, timelines can be cut, causing a ripple effect right the way through the manufacturing chain. It means that more batches, potentially up to twice as many, could be produced with much shorter turnaround times. 

However, these steel fermentation vessels still need to be drained, cleaned, sterilised and prepared, before being used again. To compress this turnaround time, single-use, disposable, “bioreactor bags” can be switched out immediately. That is time saved, which compresses the manufacturing schedule – by weeks or even months – and gets the vaccine product out of the door faster and ultimately into the arms of people at risk of disease. 

In our search for solutions, we need to cast our net wide for inspiration and be prepared to learn from technologies and expertise developed elsewhere. This might be beyond life-sciences: filters used in other industrial processes for instance, or fermentation processes that have been optimized to make beer. 

We could be looking at how to adapt the continuous manufacturing process deployed in small molecules, where, unlike manufacturing in batches, there is a continuous flow of inputs into the system. 

COVID-19 showed us what was possible, not just in vaccinology, but also in innovative ways of working. Manufacturing at financial risk was one example, with commercial-scale production starting before clinical trials had concluded to speed up the deployment of the vaccines that the entire world was waiting for. 

This is the sort of bold and creative thinking that we need to help us deliver on our 100-day mission and protect the world against future pandemics. Consider the huge leap from egg-based vaccine manufacturing to mRNA technology. We want to go that distance again. We can’t wait for innovation to come to us. We need to set out a vision for what could be done differently to change the mould of vaccine manufacturing.

Find out more about the 100 days mission here.