The development of vaccines is accelerating rapidly, and vaccine CDMOs and other contract pharmaceutical manufacturers are supporting this. The contributions these CDMOs make at various points along the vaccine development and supply chain cannot be overstated.
Vaccine CDMOs are plugging the gaps left by rapid increases in demand. They are helping pharma producers to meet the needs of communities across the world by increasing capacity and streamlining the development process. What’s more, they are freeing up in-house resources that pharma developers need to bring new vaccines to market.
At the heart of this are cold chain processes, as well as the vaccine fill/finish procedures manufacturers use to ensure their vaccines are ready for distribution. CDMOs are helping to shape best practices in both of these areas. Read on to discover more.
Cold Chain Processes
A cold chain process is an important procedure in logistics management. This procedure focuses on maintaining the same levels of temperature and the same climatic conditions throughout the entire manufacturing and distribution process, essentially guaranteeing safety and full quality control on an end-to-end basis.
In the past, this might not have been considered possible. Instead of implementing complete control over the conditions across the entire logistics chain, the focus was instead on minimizing exposure — i.e., to reduce the opportunities for perishable materials and products to be exposed to hazardous levels of temperature. In a mass vaccine roll-out context, this is simply not acceptable — manufacturers and distributors need to be able to guarantee that materials remain safe and secure every step of the way.
How Are Cold Chain Processes Shaping Vaccine Best Practice?
Refrigerated units have always been a big part of vaccine production, storage and logistics. However, cold chain processes have expanded this, creating a more unified and comprehensive process that guarantees end-to-end temperature control.
This means deploying refrigerated vehicles to transport vaccines and vaccine ingredients between locations. It also means utilizing insulated containers to achieve consistent temperatures even when vaccine materials are being transferred between facilities or between production phases. All of this needs to be underpinned by monitoring and assessment at all times so that temperatures remain consistent and no batches of the vaccine are wasted or damaged.
The cold chain process requires full engagement from all stakeholders. As the cold chain is an end-to-end concept, vaccine CDMOs also need to be on board with the initiative and equipped with all the necessary technological solutions to make cold chain procedures happen. This is becoming an important best practice in vaccine production — contract pharmaceutical manufacturers working alongside more established partners to fulfill the highest levels of vaccine demand.
The fill/finish process might seem relatively small compared to other phases of production, but it is a critical step in the development and distribution of the vaccine. Once the vaccine itself is developed and ready to go, it must be loaded into vials and sealed. These vials — as well as the seals themselves — need to be checked and assessed to ensure an excellent standard of quality control. Only after these checks are made can the vaccine doses be signed off for distribution.
This is a very vulnerable stage in the vaccine development procedure. The slightest error could lead to contamination or damage, which could in turn lead to vaccine doses or even whole batches being lost to wastage.
Automated machinery can extend the capabilities of vaccine producers when they complete fill/finish tasks, but this may not be enough to meet the high demands required during Covid-19 vaccine development and deployment. This is because the job still needs to be overseen by human teams who can ensure high standards of quality control. In other words, vaccine producers still need to devote their human resources to the fill/finish phase of production.
How Are Fill/Finish Processes Shaping Vaccine Best Practice?
The dual need to achieve high levels of volume during vaccine production and impeccable standards of quality control is shaping the vaccine workflow. The fill/finish phase is seeing some of the most rapid rates of evolution and development, but this is putting a strain upon vaccine manufacturers.
So what does this mean for vaccine best practices? It means that developers and manufacturers need to find ways to increase the capacity of their fill/finish operations and are shifting their resource allocation to accommodate this.
As the development of the vaccine is the most technically demanding phase of manufacturing — requiring high levels of scientific excellence to get it right — this phase is handled by in-house teams. The manufacturer can then outsource the fill/finish phase of development to a third-party vaccine CDMO. This more fluid and communicative approach to the vaccine supply chain — with different contract pharmaceutical manufacturers and service providers working together to complete the task — is changing the structure of vaccine development and roll-out.
The Next Stages of Vaccine Development
These evolving best practices are helping to support the next stages of vaccine development — which will be crucial to the ongoing efficacy of vaccine programs across the world. One of these next stages is likely to involve messenger RNA — or mRNA — vaccines.
This concept is not new to science. In fact, mRNA vaccines have been studied and developed by scientists for decades. However, it is only in the face of the global crisis brought about by Covid-19 that these vaccines have been made available to the general public. With an mRNA vaccine, the dose delivers information to the cells of the recipient. The recipient’s cells then use this information to recognize proteins within the virus cell on contact, triggering an immune response.
The fact that this is not a new concept but has been accelerated in its route to market is crucial here. While pharma producers are stepping up their research into vaccines and inoculations, they need to be supported by vaccine CDMOs that can meet cold chain and fill/finish standards. In most cases, vaccine CDMOs do not provide research or development services themselves, but the services they do provide are critical to the mass production and distribution of these new vaccines.