We specialize in parenteral, lipid-based drug delivery solutions, with a particular focus on lipid nanoparticle (LNP) formulations. We offer the following services to develop a formulation and define the steps, or unit operations, required to manufacture it.
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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.
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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)
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Incorporation of extrusion or homogenization unit operations to size nanoparticles (if required)
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Development of tangential flow filtration operations, including optimization of shear rate, transmembrane pressure and membrane selection.
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Design of filtration/clarification unit operations (filter selection studies, flux/throughput optimization)
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Facilitating the scale-up of all necessary unit operations, from particle generation to fill-finish.
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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)
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