Particle Sciences is the world's leading drug/device combination product development CRO. Whether it's a new chemical entity, a line extension or generic, Particle Sciences is equipped to handle the complete design, formulation and production of our client's drug eluting devices. This includes both highly potent compound and controlled substance based products. We have the industry's only complete design to commercialization solution for hormone eluting devices.
In-house capabilities include extensive modeling, physical characterization, injection molding, high shear mixing, extrusion, co-extrusion and compounding. With our in-house Analytic Services, drug release methods can be both developed and validated. The process starts with our highly refined preformulation approach, DOSE™. DOSE is based on a combination of empirically collected data and propriety computational tools Particle Sciences has built. Combined with Design of Experiments (DoE), a very efficient development process is achieved.
With combination products, polymer control and supply are especially important. Particle Sciences has established preferred relationships with the world's leading polymer suppliers and CMO's thus ensuring a seamless commercialization path for our clients.
Of course, combination product development is supported by Particle Sciences suite of cleanrooms built to handle all projects from sterile manufacturing to those involving highly potent or controlled compounds. Our analytic group takes the project from API characterization through method development and validation, ICH stability programs, into the clinic and through to NDA submission and commercialization. Particle Sciences is the leading source for concept to clinic combination product development.
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