As mentioned in our last blog centered around the regulatory challenges manufacturers will face when using mRNA technology, challenges also exist in the form of improving efficiency. However, the strive to optimise efficiency in sterile manufacturing must be balanced with the need for optimum product quality, which is directly impacted by the assurance of aseptic integrity in the manufacturing process. With the COVID-19 pandemic providing the impetus needed for the streamlining of aseptic vaccine production processes, manufacturers are now under pressure to retain this level of efficiency when using mRNA technology in the future.
Here, we look at how the desire to enhance productivity has to take into account the preservation of robust sterility demands and how single-use-technologies could provide this balance.
Achieving vaccine performance whist maximising production speed
The equipment required to attain sterility during manufacturing is very specialised, and qualified cleaning and decontamination of the equipment is mandatory after every use. This means that it can be time-consuming and costly to maintain high standards of aseptic integrity.
In order to meet demands for high-volume vaccine manufacturing, drug developers and their partners must find ways to effectively improve efficiency of aseptic vaccine production processes while maintaining sterility requirements. A new generation of cleanroom technologies has arisen to help with this task – as mentioned in the previous blog, the updated Annex 1 is expected to encourage the exploration of these new solutions to ensure sterility.
Harnessing the latest innovations in sterile processing technology
One particularly effective strategy for reconciling efficiency and sterility, is the use of Single Use Technologies (SUT).
SUTs have become increasingly prevalent in recent years as manufacturers have become aware of the benefits they provide in terms of reducing time, costs and concerns around cleaning and validation. The disposable nature of these technologies mean efficiency is increased as a result of not having to decontaminate after use, as would be required with more conventional, reusable equipment. They also help ensure aseptic integrity is maintained for the duration of manufacturing as well as transportation.
Moreover, SUTs minimise manual intervention, a key requirement of the amendments to Annex 1. This renders them a feasible introduction for the future as they comply with regulatory requirements as well as improve efficiency, as expanded upon in our previous blog.
A SUT component with potential to increase efficiency is the Split Butterfly Valve (SBV) Passive and connected intermediate container. The SBV facilitates the sterile transfer of product from one process step to another, providing separation between the product and the production environment and ensuring aseptic integrity is preserved. Naturally, this component reduces downtime by eliminating the cleaning process as a result of its disposability.
Looking to the Future
In the future as mRNA technology continues to grow in usage, drug manufacturers will have to optimise the efficiency of their manufacturing processes using new and improved approaches. This is particularly pertinent due to the speed at which the COVID-19 vaccines were developed and produced to a vast scale, meaning there is now something of an expectation that this speed can be matched henceforth.
However, this aspiration to maximise efficiency should be balanced with the need to ensure compliance to the new Annex 1 guidelines ahead of their implementation. SUTs are a key solution to help manufacturers reconcile both goals, helping them to meet growing mRNA vaccine demand well into the future.
Find out more about how using our aseptic split butterfly valve can help enhance production efficiency of your manufacturing processes whilst increasing sterility assurance.
