It is not only recently that mRNA vaccines are frequently discussed. They have immensely grown in attention among experts in the past few years, and they have also become subject of conversation in the public.
Firstly, the fields of application for mRNA vaccines widen and secondly, the industry has faced challenges in scalability transitioning from lab to bulk scale production. Both scenarios fuel the need for appropriate cold chain management solutions, considering that these biologics have special requirements especially in terms of temperature during the freezing and storage processes. This poses challenges for the mRNA vaccine supply chain that can only be faced with advanced freezing and storing technologies, as product viability and safety have to consistently be guaranteed.
mRNA – a delicate drug product
It has been a relatively short period of time that mRNA has been used within life sciences, compared to how long it has been an essential component for organisms in order to perform the process of protein synthesis: As the name suggests, messenger RNA – a type of single-stranded RNA – functions as a means for information transfer, transcribing genetic information from the DNA in the cell nucleus and delivering it to the ribosomes, which then can produce proteins accordingly.
Considering its high sensitivity and ex vivo instability, measures must be taken in order for mRNA to be used as a component of biopharmaceutical products like mRNA vaccines. This also applies to its safe and quality-maintaining storage, where ultra-low temperatures are required to preserve product viability.
Contributing to revolutionizing medicine with mRNA
Although the supply chain of mRNA vaccines brings considerable challenges with it, their relevance in today’s life sciences is unquestionable and goes far beyond the fight against COVID-19. Nevertheless, one of the most frequent examples of the immense potential of mRNA for life sciences is the result of an international feat in an attempt to develop an effective COVID-19 vaccine: Along with national initiatives like Operation Warp Speed, huge effort was put into research worldwide, allowing first mRNA vaccine candidates to be approved at an unprecedented speed.
However, the fight against COVID-19 is not the only field where mRNA has offered promising approaches – for instance, research has been going on for several years in order to create mRNA-based vaccines against cancer types, including melanoma and gastrointestinal cancer. Additionally, research has been working on mRNA-based therapeutics for various other medical conditions, such as cystic fibrosis.
These and other forms of application for mRNA give hope to millions of people worldwide and stress the necessity for process optimization in order to do justice to a presumably further increasing demand for mRNA-based biopharmaceuticals.
Single Use Support has developed an elaborate product line-up to face the challenges coming with ultra-cold supply chains
A demanding path to go – the mRNA vaccine supply chain
The supply of mRNA vaccines is a complex endeavor, since it calls for an ultra-cold chain and additionally has to meet several regulatory requirements. As long-term storage conditions have to mimic clinical conditions, recommended storage temperatures lie within the ultra-cold range, usually at approximately -80°C. Consequently, ultra-cold freezing at the manufacturer’s site is a necessary step before shipping within ultra-cold storage freezers. Designed to deliver maximum temperature stability, they provide the ideal storage conditions for the mRNA vaccines until they arrive at fill and finish sites, where they are thawed, drained and filled into vials for their application.
Temperature is key
As already mentioned, the proper storage and transport of mRNA vaccines calls for maximum accuracy in the ultra-cold chain, which begins at the manufacturing site: It commences with the product to be filled into suitable containers to then undergo a fast freezing process. At this point, plate freezing has proven to be most advantageous, as it allows fast freezing rates due to direct contact of the container with the cooled plates and thus reduces the risk of cryoconcentration.
“Manufacturers consider two factors: Achieving the best product viability and ensuring it at different scales efficiently throughout the freezing process and cold storage.” – Daniel Tischler, Head of Product Line Management
Therefore, suitable storage solutions need to be implemented in the cold chain in order to perpetuate the required storage conditions of mRNA vaccines also during their transport. This, on the other hand, requires ultra-cold storage freezers to deliver high performance as well as temperature stability: Variations in temperature can mean loss of quality and safety of the transported product, which ultimately renders it unusable. Therefore, such inconsistencies must be strictly avoided before the vaccines are due to be thawed – yet again in a controlled manner – and filled into vials.
Specialist technological solutions for even more progress
Undoubtedly, mRNA vaccines have been on the rise in recent years; scientists worldwide have proven them to be a potential key player in the treatment and prevention of various medical conditions. Along with their increasing application comes the growing need for dedicated freezing and storing solutions, given the special requirements considering their preservation. Single Use Support addresses these very needs, providing specialized freeze/thaw and storage solutions. In this regard, an entire line-up of high-end devices for efficient and consistent cold chains has been established. Amongst those are scalable freeze/thaw systems within the RoSS.pFTU platform, including single-use containers IRIS as well as the RoSS.FRDG freezer for cold storage or dedicated shipping containers. Additionally, the line-up is completed by RoSS.LN2F – a cryogenic controlled rate freezer for even lower temperatures, necessary in the process of cryopreservation. All these devices are designed to allow great flexibility, paving the way for secure and efficient supply chains.
With thanks to Single Use Support for providing the graphics for this article.
