Leverage Lipid Nanoparticles for Drug Delivery in Your Formulation
Ensure your nucleic acid cargo is well protected and appropriately delivered with our lipid nanoparticles (LNPs) support services. LNPs are common delivery methods to administer nucleic acid-based therapeutics and are compatible with multiple routes of administration, including intravenous, subcutaneous, and inhaled. These molecules protect nucleic acids from the surrounding environment and target their delivery to the tissue or cell type where action is required. We offer analytical method development, characterization, and testing for both your nucleic acid cargo and LNP products. Additionally, we provide LNP formulation and process development services.
Lipid Nanoparaticle Formulation
While LNP formulations and LNP delivery vehicles are becoming increasingly popular in nucleic acid therapeutic development, there are certain aspects to their behavior and functionality that often require expert support.
Formulating nucleic acids with a mixture of lipids is a stochastic process which requires careful monitoring to ensure an appropriate final formulation and composition. We develop custom methods to achieve the highest resolution and sensitivity for each lipid mixture used during the formulation process.
Obtaining Orphan Drug Designations in the US and the EU for Rare Disease Treatments
Orphan designation programs at the FDA and the EMA offer incentives for sponsors to stimulate drug development for rare diseases, which otherwise would not be profitable due to small patient populations. This presentation will focus on what the orphan designation and RPD programs are, the incentives for obtaining such designations, and the required data needed to position your drug for regulatory success.