These vaccines offer a favorable stability profile compared to other modalities and have demonstrated proven efficacy, making them a valuable tool in the immunization arsenal. However, challenges remain in accelerating their development.
To explore new challenges and trends in subunit vaccinology, a working group session titled “The Impact of New Technologies Enabling Rapid Protein Vaccine Development” was convened at the World Vaccine Congress Europe. The discussions highlighted several key areas crucial for the rapid development and deployment of protein-based vaccines:
1. Adoption of Innovative Technologies
The integration of innovative new technologies, such as synthetic approaches, show tremendous potential to significantly expedite vaccine development and production. However, industry-wide adaptation to these technologies is a sizable first hurdle to widespread adoption. A focus is needed on de-risking emerging technologies to foster confidence among stakeholders, including manufacturers, regulators and end users.
2. Addressing DNA Supply Bottlenecks
Ensuring a sufficient DNA supply, particularly for complex sequences, is a critical first step in recombinant vaccine production and was almost unanimously cited as a bottleneck to vaccine protein production by working group attendees. Exploring cell-free DNA production methods, could alleviate these constraints, streamlining the initial stages of vaccine development and facilitating faster progression to clinical trials.
3. Scaling Antigen Production
Efficient antigen production is vital for subunit vaccine advancement, with scaling from discovery to manufacturing titers posing a challenge. Current cell-based methods and the accompanying process development timelines were cited as a challenge that needs to be addressed2. Cell-free systems were suggested to offer a promising alternative for rapid production. Glycosylate antigens e.g. Herpes Simplex Virus are still giving challenges for cell-based production.
4. Advancing AI and Machine Learning Applications
Artificial intelligence and machine learning are emerging as transformative tools in antigen design and immunogenicity prediction. While these technologies offer significant promise, they are still in the early stages. Harmonization and standardization of analytical assays are necessary to improve AI model reliability and predictive accuracy, ultimately enhancing vaccine efficacy.
CONCLUSION
In summary, the workshop underscored the importance of adopting new technologies, addressing DNA supply challenges, scaling antigen production, and advancing AI applications to accelerate vaccine development. Collaborative efforts and continued innovation in these areas are essential to meet the global demand for effective vaccines.
A scalable protein production technology to accelerate
Our ALiCE® protein production platform is strategically designed to tackle a number of the challenges identified during the workshop. In collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), we are actively de-risking our platform to ensure its reliability and effectiveness in vaccine development.
Simultaneously, we are establishing a robust ecosystem of DNA providers and Contract Development and Manufacturing Organizations (CDMOs) to alleviate bottlenecks related to starting materials and scale-up processes. By integrating these efforts, we aim to accelerate the development and deployment of protein-based vaccines, contributing to global health preparedness and response.
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References
- Chavda, P., et. al. (2024) Protein subunit vacccines: Promising frontiers against COVID-19. J. of Controlled Release, 366, 761-782. doi: https://doi.org/10.1016/j.jconrel.2024.01.017
- Excler, J. L. et al. (2023) Factors, enablers and challenges for COVID-19 vaccine development. BMJ Global Health, 8(6). doi: 1136/bmjgh-2023-011879