With 7 different Covid-19 vaccines now publicly available and ~1 billion doses having been administered, now is a good time for an interim review of how Malvern Panalytical has been able to support these developments. We are proud to share that our analytical instruments and expertise have supported SARS-CoV-2 vaccine labs across the globe, advancing the development of all 3 major vaccine types currently on the market.
Effective drug delivery systems
Winter 2020/21 marked the first entry onto the market of ribonucleic acid (RNA) based vaccines. Delivery to the recipient’s immune system of messenger RNA (mRNA) coding for the SARS-CoV-2 ‘spike protein’ causes production of this protein, stimulating an immune response without risk of infection. The mRNA is generally delivered using lipid-based nanoparticles), with their physicochemical nature being key to the high efficacy of these vaccines.
The past year has seen the Zetasizer Advance and NanoSight NS300 used extensively by vaccine developers, and their supply chains, allowing them to optimize the delivery of mRNA and hence the efficacy of the vaccine. Through concentration calculation, these technologies also monitor the yield/dosage at different steps of the nanoparticle development process. The importance of timely and predictable manufacture of vaccines at a time like this cannot be overstated, and this data has helped developers design, scale up and control their manufacturing processes with the required rapidity.
Enabling efficient scale-up and manufacture on limited timescales
Adenovirus-vectored vaccines (estimated to account for around 1/3 of the total doses given so far), consist of a relatively harmless ‘cold’ virus that delivers DNA encoding the ‘spike protein’ to the recipients immune system. The advantages of this platform include ease of manufacturing and an accordingly low cost. The Zetasizer Advance is used to measure both the particle size and yield of adenovirus particles, helping developers optimize their adenovirus production platforms to produce a quality product with minimal time constraints.
Another advantage of the adenovirus platform is that there is potential for such vaccines to be administered through the respiratory tract. This may well be an advantage for protection against a respiratory disease such as COVID-19, in addition to the convenience of spray administration. Malvern Panalytical’s Spraytec laser diffraction particle and droplet sizing technology is advancing research of such vaccines through the characterization of spray-droplet size (critical to the effectiveness of such vaccines).
Finally, with adenovirus-vectored vaccines relying on the integrity of proteinaceous material for both their safety and efficacy, stability analysis is key to optimizing shelf-life. Our MicroCal differential scanning calorimetry (DSC) systems are used by formulators across the world to produce protein therapeutics that are stable enough to be stored for long intervals at low temperatures, another key benefit of adenovirus-vectored vaccines.
A more traditional vaccine component, including those using inactivated whole-cell technology (which constitutes a significant minority of the COVID-19 vaccine doses administered so far), are adjuvants. Adjuvants act to enhance antigen-specific immune responses, with the adjuvant particle size having a major impact on the level of enhancement. Malvern Panalytical’s Mastersizer 3000 is used to characterize adjuvants to optimize their safety and effectiveness, both key for any new vaccine entering the market.
Though vaccination is key to reducing the impact of the pandemic it is likely that COVID-19 will still be with us for some time, and those infected will continue to require treatment. Accordingly, Malvern Panalytical is working with numerous labs around the world to develop treatments for those affected. McGill University in Canada, for instance, is using MicroCal isothermal titration calorimetry (ITC) to identify drugs that will inhibit viral replication. The unique abilities of this technology to directly (without sample modification) and comprehensively measure the processes involved in such inhibition processes “facilitate the work of developing them into drugs that are both highly effective and safe”.
Collaborating with our customers in the vaccine industry over this past year in order to help prepare the world to deal with the current pandemic has been both humbling and inspirational. We have enjoyed broadening our insights into the value our technologies add to pharmaceutical development, and we look forward to continuing our support over the coming years.