Scale-up of a novel hyaluronan-based delivery system

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A hydrogel platform was engineered to provide sustained release of biomolecules. The product addresses an unmet need in the post-operative pain market and will provide extended pain-relief to the user. This proposal focuses on optimizing the formulation for sustained release based on a series of design criteria, scale-up manufacturing, sterility and stability. We propose to build on a successful phase I I2I where we formed and financed AmacaThera with $4.7million in seed capital. In this phase IIb I2I proposal, we aim to advance the manufacturing and scale-up of a product designed for post-operative pain to ensure that we can manufacture at scale a uniform product, with controlled release attributes that is both sterile and stable on the shelf. This proposal is a strong academic-industry partnership between The Shoichet Lab and AmacaThera, taking advantage of research excellence from the Shoichet lab and business acumen from AmacaThera.