How Biopharma Group Can Help Achieve Your mRNA Therapeutics Ambitions
A new era in vaccinology is upon us. mRNA was at the forefront of significant advancements in therapeutics and vaccine development long before the Covid-19 pandemic, but it was the development of Covid-19 vaccines – notably Pfizer and BioNTech’s – that propelled mRNA therapeutics to global renown.
mRNA therapeutics holds exciting possibilities for the development of new vaccines. Despite this potential, mRNA’s low fidelity and stability can pose obstacles for scientists.
This article explores how your mRNA therapeutics ambitions can be achieved with the help of Biopharma Group’s innovative freeze drying solutions.
The potential of mRNA in vaccinology
mRNA therapeutics have revolutionised how vaccines are developed. An attractive source of antigen, mRNA is advantageous in vaccinology for the adaptability it offers – both in the amount and nature of epitopes it encodes.
The full potential of mRNA medicine is yet to be realised. With ongoing advances, it is expected that mRNA will improve outcomes of diseases, viruses and genetic disorders for people across the world. mRNA gives scientists the opportunity to treat and prevent ailments that we currently cannot. Directing protein production from inside cells is something that is not possible with other medicines, so the potential mRNA holds is unfathomable.
Already, mRNA-based therapies are in development for malaria, multiple sclerosis and cancer. The speed and adaptability of mRNA make it an attractive base for vaccines. As shown during the Covid-19 pandemic, mRNA vaccines can be developed and adapted quickly in vitro for antigen targets. This increased development speed allows vaccines to come to market more quickly – a time saving which saves lives.
Challenges of mRNA therapeutics
In addition to the exciting possibilities mRNA offers, it also brings a set of challenges. One of the most significant difficulties with mRNA is its fast degradation time.
Compared to DNA, mRNA lacks stability and degrades much faster. To preserve the APIs, mRNA vaccines must be frozen at -80°C for long-term storage.
The challenges of storing and transporting mRNA vaccines were brought to the fore during the rollout of Pfizer and BioNTech’s Covid vaccine. Due to the nature of mRNA, traditionally the vaccines needed to be stored at -70°C and for a maximum of ten days. This limited transport and storage to 5,000 doses at a time.
There is an intelligent solution to the challenges of storing and transporting mRNA-based vaccines: freeze drying.
Lyophilisation: the freeze drying solution for mRNA vaccines
Freeze drying, or lyophilisation, is the solution you need to achieve your mRNA therapeutics ambitions. Biopharma Group offers comprehensive lyophilisation solutions to help you during the research and development stage of mRNA medicines, including bespoke solutions. Lyophilisation makes it possible to produce high-quality, viable mRNA-based vaccines in a stable format with rapid reconstitution capabilities.
Lyophilisation is a product and liquid formulation drying process that is used to adapt samples into a format that is viable, yet suitable for storage, shipment and reconstitution into a stable, safe product for end users.
So how is this achieved? First, product samples are frozen to manipulate the ice crystal structure, before the pressure is dropped to achieve sublimation in vacuous conditions. This is the primary drying stage where unbound water is removed from the sample. During the secondary drying stage, bound water is sublimated to a chosen residual moisture level. Freeze drying conditions are variable to accommodate the unique properties of different samples.
The freeze drying process ensures that the stability and active ingredients of the sample are maintained. By limiting the degradation of molecules, the sample is still viable post reconstitution. Freeze drying allows samples to be stored for longer periods without relying on cold supply chains, thereby extending product shelf life and making it easier to distribute around the world.
Biopharma Group’s freeze drying solutions
Lyophilisation solutions are becoming increasingly popular in pharmaceutical and diagnostic sectors due to the possibilities they offer for mRNA therapeutics. Biopharma Group provide innovative freeze drying solutions to facilitate the research and development of mRNA-based medicines.
At Biopharma Group, freeze drying is our speciality. From cutting-edge equipment to product and process development, contract manufacturing to analytical instruments and lyo training courses, we have everything you need to achieve your mRNA-based drug ambitions. We even provide consultancy and lyophilisation training courses to help you enhance your capabilities, including collaborative development on new projects.
To find out more about our freeze drying solutions and how they can support mRNA-based vaccine development, contact us today.