SFF
mRNA therapeutics hold immense promise for treating previously untreatable diseases, but their development and manufacturing are not without challenges. A key hurdle lies in the inherent instability of mRNA molecules. These molecules are susceptible to both physical and chemical degradation, potentially leading to short shelf life and the need for stringent cold-chain storage and transport.
Physical instability can manifest as the loss of crucial structural elements, aggregation and precipitation, hindering the translation of mRNA molecules into functional proteins. Chemical instability arises from degradation processes like hydrolysis and oxidation, further compromising the mRNA therapeutic's integrity and efficacy.
Failure to address these instability issues during development can result in products with limited shelf life or those requiring ultra-low temperature storage and transport. These stringent storage requirements can hinder global access to these innovative therapies, particularly in regions with limited cold-chain infrastructure.
In a recent article with International Pharmaceutical Industry (IPI) Magazine, Vincenza Pironti, Head of Business Development at Recipharm, explores these development challenges and discusses how lyophilisation can hold the key to optimising stability during mRNA production when the therapies are in storage and transit, so long as key hurdles can be overcome. These include:
- Producing a high-quality final cake that can be easily reconstituted
- Maintaining the integrity of lipid nanoparticle formulations
- Expediting the lyophilisation process to deliver to patients sooner.
Read the full article on page 20 and learn more.