Interest in RNA therapeutics is growing rapidly within the pharmaceutical industry, it has the potential to treat and prevent many human diseases while being relatively safe and cost effective. This promise has led sponsors to actively research RNA based drugs for a broad array of applications.
Sponsors regularly use contract organisations for development and manufacture of RNA products, while interaction with contract organizations for regular biologics is widely established and has been routinely performed by Sponsors, it is still in infancy stage for RNA products. The unique aspects of RNA can result in unique challenges that may not be addressed if the same process of standard biologics transfer is followed, making the requirements for RNA products potentially less clear. Furthermore, some contract organizations are new to the RNA field and thus might overlook important RNA specific considerations.