Interest from pharmaceutical companies in mRNA (messenger Ribonucleic Acid) vaccine technology has never been higher. This is being driven by the need for vaccines to tackle the COVID-19 pandemic, as well as the technology’s potential to revolutionise a range of other treatment areas. As a result, the market is expanding rapidly, and is projected to reach US $5 billion by 2026.
mRNA vaccines stimulate the immune response in a patient’s body, much like standard vaccines, helping to prevent potentially serious illness or even death for illnesses such as cancer, HIV, influenza and even genetic disorders. However, instead of the vaccine containing a weakened/inactivated form of the virus, the vaccine contains genetic material coding for a disease-specific-protein to the virus. This genetic material integrates into your cells, which produce the protein and generate an immune response against that protein, so when you are exposed to the actual virus, you have a pre-existing immune response.
Nevertheless, drug manufacturers do face a range of challenges when manufacturing them to bring them successfully to the market. One of the biggest obstacles is ensuring compliance with GMP Annex 1 regulations giving guidance on the manufacturing of sterile medicinal products and, thus, aseptic integrity of the production and filling process.
Here, we dive into the compliance issue and explain how companies who want to use mRNA vaccine technology can address challenges through the use of single-use technologies (SUTs).
Meeting new Annex 1 regulations
The EU GMP Annex 1 is the central document that governs the manufacture, control and release of sterile pharmaceutical products, such as mRNA vaccines. Amendments to Annex 1 of the EU’s Good Manufacturing Practices (GMP) have now been published, which is likely to bring significant changes to how manufacturers ensure sterility in drug development.
Key to compliance with these new regulations will be the implementation of a Contamination Control Strategy (CCS) within drug developers cleanroom zones. This consists of a formally documented plan in place to ensure a high degree of assurance that the final product is not subject to contamination. It should take into account numerous variables that can affect contamination control providing a comprehensive evaluation of the likelihood of contamination, which is frequently reviewed and updated if appropriate. A detailed CCS which maximises the likelihood of sterility assurance includes the use of technology at critical points in the process.
Harnessing the latest innovations in sterile processing technology
An effective strategy for ensuring compliance with Annex 1 by supporting the implementation of an effective CCS, is the use of single-use technologies (SUT).
SUTs are disposable products designed to be discarded after one-time use, and in recent times have been shown to provide a more than capable alternative to the established cycle of re-using equipment. These technologies help to ensure aseptic integrity throughout manufacturing and transportation, as well as reducing the time and costs associated with packaging and decontaminating reusable containers.
Not having to decontaminate after use of course improves efficiency, but importantly it also minimises manual intervention, a key requirement of the amendments to Annex 1, rendering it a practical solution to the regulatory challenges manufacturers will imminently face.
A particular SUT component that can aid in the endeavour to meet new regulatory guidelines is the split butterfly valve (SBV). The SBV allows for closed transfer of powders form one process step to another, providing separation and aseptic integrity between the product and the environment before, during and after the transfer. Importantly, the SBV can simply be disposed of after usage, meaning no need to decontaminate, thus decreasing manual interventions.
Looking to the Future
Regulatory compliance is just one of the challenges manufacturers face when delivering volume production of mRNA vaccines. In our next blog, we will explore the need not just to comply with regulations, but to achieve optimum line productivity too.
Also, find out more about how using our aseptic split butterfly valve can help you meet the revised Annex 1 guidelines whilst increasing sterility assurance.
