Leveraging prefabricated factories to geographically diversify health product manufacturing
Pandemics like the one we experienced a few years ago are a once-in-a-lifetime occurrence. Or so we’d like to hope.
As scientists track the development and circulation of viruses in different animals, it is becoming increasingly clear that concerns about another pandemic are not unfounded. Specifically, avian influenza viruses pose a significant risk to public health due to their widespread circulation in birds and mammals and the possibility of spillovers into human beings. In other words, there are influenza viruses with human pandemic potential.
If we want to prevent another pandemic, we have to get ahead of viruses which have human pandemic potential. We have to study their evolution, develop and produce appropriate vaccines, and most importantly, ensure that all countries and communities have access to them. After all, we are only as strong as our weakest link. Leaving any country behind would be not only a failure of global health equity but also a looming threat of the disease spreading to other parts of the world.
Leveraging the mRNA technology transfer programme to build capacity in LMICs
As devastating as the Covid-19 pandemic was, it left the global health community with important lessons in preventing future disease outbreaks of this scale. The mRNA technology transfer programme, jointly developed by the World Health Organisation (WHO) and the Medicines Patent Pool (MPP), was a tangible consequence of these lessons.
Launched in July 2021, the mRNA tech transfer programme was developed to build sustainable, locally owned capacity to develop and manufacture mRNA-based vaccines in low- and middle-income countries (LMICs). The Afrigen, South Africa-based hub developed and implemented a platform that was used to establish the efficacy and safety of a Covid-19 vaccine candidate. But its work extends beyond Covid-19 to develop mRNA vaccines for other disease targets.
Three years later, in July 2024, the WHO announced the launch of a new project under the tech transfer initiative. This project aims to accelerate the development and accessibility of mRNA vaccine candidates for the human avian influenza H5N1 virus aka a bird flu subtype.
The Argentinian manufacturer Sinergium Biotech, who is leading this project, has developed H5N1 vaccine candidates and is working to establish proofs-of-concept for them in preclinical models. Once this preclinical data package is ready, Sinergium will share its technology, materials and expertise with manufacturing partners in other LMICs. This collaborative approach will speed up the development of H5N1 vaccines and equip us with the tools we need to prevent a future avian influenza pandemic.
This initiative is an important step towards fortifying global pandemic preparedness efforts. It highlights the importance of early planning for equitable vaccine access. But most importantly, it is a testament to a truly global approach to addressing health threats that affect us all.
When Covid-19 vaccines and mpox vaccines were developed, wealthy nations were at the front of the vaccine access line, buying and stockpiling them while LMICs struggled to get their hands on these essential interventions. By enabling more research, development and manufacturing in LMICs, the hope is that we will avoid such scenarios from repeating themselves. The hope is that when the next pandemic comes, the whole world – and not only affluent nations – will be prepared to implement an effective response that benefits people across countries, regardless of economic, social or political status.
“When we created the mRNA Technology Transfer Programme with WHO, our goal was to enable low- and middle-income countries to lead development efforts, foster collaboration, share resources, and disseminate knowledge. This project embodies our vision and demonstrates a strong commitment to future pandemic preparedness and response.”
— Charles Gore, Executive Director, MPP
Deploying prefabricated pharma factory systems to democratize vaccine manufacturing
This latest project under the mRNA tech transfer programme will enable manufacturers in multiple LMICs to access the technology and expertise required to make H5N1 mRNA vaccines. Nonetheless, these manufacturers need physical cleanroom infrastructure to put the acquired know-how to good use. Think laboratories, vaccine manufacturing for clinical trials, diagnostics production, and more.
Setting up the required cleanroom systems is no piece of cake. The entire process involves not only designing, engineering and equipping the factory but also automation, factory acceptance testing (FAT), site transfer, commissioning, and qualification documentation. Not to mention diverse local permissions and approvals before the facility can be up and running.
On the whole, establishing a fully equipped, high-quality cleanroom to develop and manufacture candidate vaccines for H5N1 can be an expensive and time-consuming affair. But it doesn’t have to be. That’s where prefab pharma factories, like the ones PodTech™ can engineer for you, come into the picture.
The flexibility, scalability and speed of setup of PodTech™’s podules™ make them ideal to help realise the vision for truly global and equitable pandemic preparedness.
In its strategy for 2022 to 2026, the Coalition for Epidemic Preparedness Innovations (CEPI) aims to respond to the next Disease X threat with a new vaccine in only 100 days or about three months from the recognition of the threat to a vaccine being ready for initial authorisation and large-scale manufacturing. The strategy aims to prepare the world for known epidemic and pandemic threats, transform the response to pathogenic threats by harnessing technological innovations, and connect relevant stakeholders to ensure effective and equitable vaccine access.
CEPI recognises that greater speed in developing and manufacturing vaccines manifests as greater equity. Greater speed protects those at the greatest risk from viral threats. The greater the speed of vaccine development, manufacturing and distribution, the smaller the outbreak is likely to be.
The mRNA tech transfer programme’s new project, combined with PodTech™’s podules™, can check important boxes for pandemic preparedness, especially for LMICs that have traditionally been left out of tech sharing and R&D in the pharma space. Think speed, collaboration, innovation, and agility. Think PodTech™ to realise the vision of a truly equitable response to emerging pandemic threats.