With the world facing threats from new and emerging infectious diseases, the ability to rapidly ramp up production of essential raw materials for vaccines and therapeutics has become crucial.
In 2018, the WHO introduced the term ‘Disease X’ to describe an unknown infectious pathogen that could cause an epidemic or pandemic. The term was introduced to facilitate rapid public health response and encourage vaccine research, treatment rollout and diagnostic test development. However, the Covid-19 pandemic response in 2020 faced challenges; the UK’s official Covid-19 Inquiry report[i], for example, stated that government officials had been planning for the ‘wrong pandemic,’ concentrating on building up a national stockpile of flu vaccines but not considering a SARS type virus.
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During the pandemic, vaccine supply chains emerged with a cross-border nature, including trade in specialised inputs. This led to the establishment of multiple supply chains, fearing governments would resort to ‘vaccine nationalism’ and refusing to export doses until populations were fully served. Pharmaceutical companies learned that providing vaccines to other markets meant also manufacturing them from other markets. Some vaccines required additional nodes of production, such as separate mini-supply chains, feeding into the main manufacturing supply chain.
For instance, Pfizer/BioNTech and Moderna required massive volumes of lipid nanoparticles, while Novavax required a specialised adjuvant to boost the body’s immune response. Companies also reported limited availability of critical inputs, such as single-use bioreactor bags, filtration pumps, filters, skilled workers, financial capital and partner companies with idle capacity, which hindered their ability to quickly scale up production processes[ii].
As countries prepare for the ‘next pandemic,’ the prototype pathogen approach[iii] is being used. This approach relies on the fact that viral families often share functional and structural properties, meaning vaccine efficacy will also be similar. The hope is that vaccine developers can quickly pivot to the necessary pathogen in case of a pandemic. The rapid development of vaccines for SARS-CoV-2 during the Covid-19 pandemic was made possible through a combination of leveraging existing research on related viruses, employing proactive vaccine strategies and utilising then-emerging mRNA technology. These strategies not only addressed the immediate health crisis but also set a precedent for future pandemic preparedness.
However, vaccines are just part of the story. Strengthening domestic production capabilities and ensuring a resilient supply chain are key components of this preparedness.
Lessons from recent outbreaks
The recent mpox outbreak has demonstrated that vaccine supply can be critically low during health crises. For instance, vaccines for mpox are currently in extremely short supply in countries experiencing rising cases, underscoring the necessity of a coordinated international response that pressures countries with stockpiles to share resources. Due to a lack of local manufacturing experience, sub-Saharan Africa and low- and middle-income countries rely heavily on imports for vaccine production[iv] . This situation echoes the experience during the Covid-19 pandemic. Vaccine distribution faced significant bottlenecks, illustrating the fragile nature of global supply chains.
Strengthening domestic production capabilities is essential in ensuring health security. The US has recognised this need through the American Pandemic Preparedness Plan (AP3)[v], which sets a goal of developing a vaccine within 100 days of identifying a pandemic threat. This plan emphasises the establishment of necessary infrastructure to support rapid vaccine production and distribution.
mRNA vaccines are excellent candidates because they use synthetic messenger RNA to instruct own cells to produce a specific protein to trigger an immune response to the pathogen. This means they can be designed and manufactured in days once the target’s genetic sequence is known, significantly shortening their production time compared to traditional vaccines, which rely on proteins or viruses. Additionally, mRNA vaccines allow for rapid updates to target emerging strains of viruses, a major advantage over traditional vaccines that may require extensive redesign and testing if a new variant arises.
Ensuring a resilient supply chain
Supply chains are seen as the key factor in all these plans. mRNA vaccines are characterised by their rapid production capabilities and reliance on enzymes and synthetic components like cap analogs, nucleotides, and lipid nanoparticles. Investments in advanced manufacturing facilities that can process these components are pivotal to rapid response strategies, paving the way for a more secure and responsive public health infrastructure — quickly funnelling crucial raw materials to trailblazing biomanufacturers.
A trusted partner of research institutions and biotech companies for more than 25 years, TriLink BioTechnologies is a leading supplier in mRNA manufacturing. Leveraging their decades of expertise in nucleic acid chemistry, TriLink offers critical mRNA components such as CleanCap® cap analogs, modified and unmodified nucleotides, and in vitro transcription (IVT) enzymes for the development of mRNA therapeutics and vaccines. Its CleanCap analogs and nucleotides are available as GMP for a seamless transition from discovery to clinical and commercialisation. It is worth noting that TriLink’s GMP CleanCap analogs have already been used in three commercially approved RNA vaccines.
TriLink manufactures its GMP-grade mRNA raw materials in two facilities in San Diego, California: one intended for early-phase clinical materials and the other designed for small-scale and scale-up materials for late phases and commercialisation. The latter facility is 32,000 ft2 (2,973 m2), completed in May 2023 with $39M investment from the US Bureau of Biotechnology and Development (BARDA) to manufacture nucleic acid reagents for medical countermeasures. The facility is designed to address modern health security threats like pandemics and is partially funded by the US Department of Defense and Health and Human Services.
The new facility is equipped with five ISO class 7 suites for manufacturing and fill/finish of GMP-grade nucleic acid products. At full capacity, it can manufacture >600 kgs of materials per year — more than seven times TriLink’s capacity during the pandemic response. TriLink’s goal is to continue enabling mRNA drug and vaccine manufacturers with outstanding-quality raw materials at a faster pace and a larger capacity to push the boundaries of configurable medicines.
TriLink’s facilities are ISO 9001:2015 certified, with adherence to GMP principles where applicable, providing assurance that their GMP mRNA raw materials meet stringent requirements for identity, purity, and safety. Additionally, its dedicated team of experts is available worldwide to discuss customer needs, provide technical support, and accommodate quality audits.
Investments in innovative manufacturing facilities like TriLink’s San Diego facilities are crucial for establishing a secure public health infrastructure and enabling the rapid production of vaccine raw materials for infectious illnesses. With such adaptable, experienced partners on hand, biomanufacturers can stand at the forefront of developing and commercialising mRNA medicines more efficiently than ever, allowing life-saving new therapies to reach the market faster.
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[i] https://covid19.public-inquiry.uk/reports/module-1-report-the-resilience-and-preparedness-of-the-united-kingdom/
[ii] Bown CP, Bollyky TJ. How COVID-19 vaccine supply chains emerged in the midst of a pandemic. World Econ. 2022 Feb;45(2):468-522. doi: 10.1111/twec.13183. Epub 2021 Oct 28. PMID: 34548749; PMCID: PMC8447169. https://pmc.ncbi.nlm.nih.gov/articles/PMC8447169/#twec13183-sec-0003
[iii] Cassetti MC, Pierson TC, Patterson LJ, Bok K, DeRocco AJ, Deschamps AM, Graham BS, Erbelding EJ, Fauci AS. Prototype Pathogen Approach for Vaccine and Monoclonal Antibody Development: A Critical Component of the NIAID Plan for Pandemic Preparedness. J Infect Dis. 2023 Jun 15;227(12):1433-1441. doi: 10.1093/infdis/jiac296. PMID: 35876700; PMCID: PMC9384504.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9384504/#:~:text=The%20goal%20of%20the%20prototype,of%20the%20same%20viral%20family.
[iv] Bown CP, Bollyky TJ. How COVID-19 vaccine supply chains emerged in the midst of a pandemic. World Econ. 2022 Feb;45(2):468-522. doi: 10.1111/twec.13183. Epub 2021 Oct 28. PMID: 34548749; PMCID: PMC8447169. https://pmc.ncbi.nlm.nih.gov/articles/PMC8447169/#twec13183-sec-0003
[v] https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf?page=29
