While technology transfers can be a challenge with any drug product, even greater vigilance is needed with more complex formulations such as lipid nanoparticle-based (LNPs) drugs. These complex formulations have structural similarities to naturally occurring biological vehicles; as a result, they are generally well tolerated by the body. Therefore, LNPs are increasingly being used to deliver highly specialized therapeutics molecules, such as oligonucleotides, which are seeing heightened attention in drug development due to their ability to tackle disease on the genetic level.
Despite the growing body of research and scientific knowledge, LNP formulations are inherently complex and require a more comprehensive manufacturing and testing approach. The stability profile of the finished formulation is very dependent on lipid selection and the manufacturing process. Many involve novel payloads or APIs, and interactions between the various compendial raw materials are not fully understood.