The rapid development and roll-out of effective vaccines to tackle the 2 (SARS-Cov-2) virus that causes COVID-19 was made possible thanks in part to the use of cutting-edge new messenger RNA (mRNA) genetic vaccine technology.
While still in their infancy, mRNA genetic vaccines offer considerable benefits compared to other approaches that make them a highly attractive alternative for vaccine development:
- Adaptability: mRNA vaccines are uniquely adaptable, meaning they can be used to develop vaccines for a wide array of pathogens, and updated rapidly to tackle new variants or new pandemic viruses
- Resource efficiency: due to the adaptability of the platform, mRNA vaccines are quicker to develop and manufacture than traditional vaccines
These benefits make mRNA genetic vaccines an exciting new frontier in medical technology. However, they do pose challenges, not just during the development stage, but during the manufacturing and filling process that need to be overcome to ensure their successful delivery to market.
Exploring development obstacles
There are many development pitfalls that need to be overcome to successfully commercialise a new mRNA vaccine.
These include:
- The technology’s novelty: as of yet, there are few platforms that can provide templates for developing promising and scalable vaccines quickly
- Bringing vaccines to trial: as a cutting-edge technology, mRNA vaccines require considerable development work to ensure their viability and safety
- Navigating regulatory approval: For such a new technology, regulators require considerable evidence from unimpeachably performed trials before they give authorisation
Tackling manufacturing challenges
mRNA vaccines face more than development barriers on their journey to market. There is a number of obstacles at the manufacturing and finishing stage that also need to be overcome to ensure successful commercialisation and delivery. The key challenges to look out for include:
- Sterile manufacturing and aseptic fill-and-finish capacity: as with other vaccine technologies, mRNA vaccines must be manufactured and filled in a sterile environment. Few companies have the established cleanroom infrastructure to provide the needed contained manufacturing or aseptic fill-and-finish. Many will need outside support from the limited number of contract sterile filling and manufacturing partners to deliver finished batches quickly, efficiently and reliably
- Supply chain issues: again, with experience in genetic vaccines at a premium, few companies have access to suppliers with the experience to provide the specialist raw materials in a sustainable and secure supply
- Transport and storage challenges: the nature of mRNA vaccines means that they pose stability issues, requiring cold storage as low as -70° C. This creates challenges when it comes to transporting such vaccines to clinics, particularly in developing countries where the cold-chain logistical infrastructure may not exist. The short shelf life of genetic vaccines also means that pharma companies must be able to manufacture and deliver new batches of vaccines to where they are needed quickly and efficiently
The importance of working with expert partners
While these are significant challenges, they needn’t hinder future mRNA vaccine development success. There are expert contract development and manufacturing organisation (CDMO) partners that specialise in the development and manufacture of such vaccines and can also offer contract sterile filling services to support pharma companies in delivering their vaccine to market.
Recipharm, for instance, has several services that are ideal to support new mRNA vaccine projects. Our facility in Wasserburg, Germany, for example, has expertise in the aseptic fill-and-finish of biologics, such as vaccines.
We can support in manufacturing a host of sterile products, including liquid solutions and lyophilised powders, in both high-volume commercial batches and small-batch sizes for clinical trial. We have expertise in filling a range of containers, from vials and ampoules to cartridges for pre-filled syringes.
In addition, we can offer a full analytical service for release and stability testing for vaccines. Our regulatory intelligence can support pharma companies in regulatory activities, accelerating and streamlining the filing process. We also have Quality Persons (QPs) qualified to certify vaccines for the EU market.
By working with such expert partners, pharma companies can be confident they have the support and guidance needed to harness the potential of mRNA vaccine technology, and bring new vaccines to market quickly, as and when they are needed.
To find out more about how Recipharm can support your vaccine development, read our eBook, How to speed up vaccine development and production, today.
To learn about Recipharm’s specialist sterile manufacturing and aseptic fill-and-finish offering, click here.