Understanding the obstaclesThere are a number of obstacles that hinder the speedy development of effective vaccines:
The nature of the pathogenThe ease or complexity of vaccine development is partly related to the inherent properties of the organism responsible for the disease. These properties include tissue and cell tropism, immune defense mechanisms, and inherent molecular biology, to name but a few. Pathogens that show high rates of antigenic shift, such as influenza or SARS-CoV-2 and other RNA viruses, pose one such challenge. Such viruses evolve new variants very quickly, which can quickly render a vaccine ineffective. Constant surveillance is required to identify the most concerning new variants in order to recompose the vaccine often with a seasonal cyclicality.
Developing viable formulationsThe discovery of vaccine candidates that are effective against serious illness is not the only challenge. Developing these promising innovations into viable products with the stability, storage and administration compatibility fit for widespread distribution and use is another obstacle that needs to be overcome. This is especially pressing when the disease in question is causing a health crisis in developing nations. Emerging countries often lack appropriate facilities for vaccine storage at sustained sub-zero temperatures at or near the point of treatment, which can pose issues in launching vaccination programs that require cold-chain storage. With this in mind, developers must devise vaccine formulations capable of being stored and transported at temperatures that don’t restrict their widespread use –at +2-8°C, say, compared to -80°C. Formulations must also allow for in-use stability, in the brief window between removal from storage and administration. They must be able to remain stable in tropical environments, where temperatures might exceed 30°C.
Developing new vaccines quicklyAs the COVID-19 outbreak has demonstrated, time is often at a premium when developing new vaccines, in order to save lives and relieve the burden on health services. However, discovering a viable vaccine candidate, bringing it to clinical trial, then successfully commercializing it, can take a long time, and there is no guarantee of success. All too often, candidates fail at some point along the development process, requiring companies to start again from the beginning. While this is happening, people continue to contract the disease, sometimes becoming seriously ill.
Overcoming challengesThere are a number of ways these obstacles can be tackled to successfully develop new vaccines and effective formulations. To shorten formulation development timelines and maximize the chance of success, accelerated temperature predictive modeling is key. However, this requires robust and well-designed analytical assays to assess a formulation’s performance. Large pharma companies often have such capabilities in-house, although start-up or developing companies generally have limited resources, equipment, or experience to perform particular analytical characterization. In this instance, companies often elect to outsource these studies to contract testing organizations with the appropriate scientific expertise, as well as advanced high-throughput technologies. These contract service providers will also have Design of Experiment (DoE) expertise to further accelerate the process of method development, assessment and acceleration of reliable data generation. With regards to ensuring stability during transit and storage, formulation approaches, such as lyophilization, spray-drying or vacuum-drying can enable long-term stability and storage at +2-8°C or even ambient temperature. These solutions have the potential to overcome formulation issues at the commercial stage, streamlining time to market for new vaccines.
The value of vaccine platformsOne exciting development that came into its own during the COVID-19 pandemic as a way of significantly accelerating vaccine development for serious diseases is the creation of vaccine platform technologies. Such platforms form the basis for the development of a wide array of COVID-19 vaccines. The Oxford/AstraZeneca vaccine, for instance, is based on a chimpanzee adenoviral vector (ChAdOx1), while the Pfizer and Moderna COVID-19 vaccines use another technology platform based on messenger RNA (mRNA). The advantage of this kind of platform approach is that the different vaccine products are, with the exception of the disease-specific transgene, the same. This shortens the production timeline, as the producer cell bank and expression technology is already in place and the vaccine design tools and manufacturing infrastructure are already established. Moreover, formulation and stability data are available from products previously developed with the same platform technology. As a result, harnessing the power of platforms can potentially transform the fight against hard-to-prevent diseases, allowing us to significantly speed up development of new vaccines to keep one step ahead of the pathogen.
Benefiting from expert supportVaccine development is a rewarding, but highly challenging field to work in. Whether using exciting new platform technologies or not, for promising vaccine candidates to achieve their full potential, pharma companies need expert support. With the right contract development and manufacturing organization (CDMO) to help them, they can develop their discoveries to the clinical trial stage and beyond to full commercialization, with minimal delay. CDMO partners like Vibalogics can offer dedicated expertise in the latest approaches, such as platform technologies, to support biopharma companies in developing their innovations successfully and in the shortest possible timeframe. With such a partnership, drug developers can be confident that they have the support they need to ensure the success of their new vaccine. To find out more about how we can speed up your vaccine development, contact our team today.