FORMULATION DEVELOPMENT
Develop the optimal formulation for your drug.
We specialize in parenteral, lipid-based drug delivery solutions, with a particular focus on lipid nanoparticle (LNP) formulations.
Design of an optimal liposomal/LNP formulation for a client’s candidate API. This includes the selection of excipients and vendors, as well as the synthesis of multiple bench-scale samples (>20 mL) to support client-based screening assays and in vivo protocols.
Establishment and optimization of either a simple fluidic connector-based approach or a reverse-phase evaporation process to generate nanoparticles (key process variables include mixing flow rates, ratios, concentrations and temperatures)
Incorporation of extrusion or homogenization unit operations to size nanoparticles (if required)
Development of tangential flow filtration operations, including optimization of shear rate, transmembrane pressure and membrane selection.
Design of filtration/clarification unit operations (filter selection studies, flux/throughput optimization)
Facilitating the scale-up of all necessary unit operations, from particle generation to fill-finish.
Assist in the transfer of a client’s formulation to a cGMP environment (e.g. in-process hold studies, temperature studies, nitrogen blanket studies, material compatibility studies)
