DigiM Awarded FDA Contract to Study Critical Performance Attributes of Polymeric Microsphere Products

DigiM Solution LLC, a technology leader in microstructure analysis, has received a broad agency award (BAA) from the U.S. Food and Drug Administration (FDA). The goals of the project are to build an understanding of critical performance attributes of polymeric microspheres, with the aim to assist the FDA’s efficiency on bioequivalence approaches for complex polymeric injectable products.

The study is a joint collaboration between DigiM and the laboratory of Prof. Diane J. Burgess at the University of Connecticut in Storrs, Connecticut. A lack of fundamental understanding of the release mechanisms of polymeric microsphere drug products creates challenges for establishing bioequivalence, particularly for locally acting depot formulations. This new collaboration seeks to build upon the success of the previous collaboration between UCONN and DigiM which characterized the long acting microsphere product Arestin.

The previous collaboration laid down the framework for characterizing extended release microspheres, and in this work the objective is to use these imaging workflows to build up a robust understanding for these systems on a more general scale. Specifically, DigiM aims to establish a matrix of critical performance attributes (CPAs) determined from microstructure imaging, and use that to guide generic formulations of long acting microsphere systems. These CPAs will then be used by UCONN to develop new formulations using a rational Quality by Design approach in a targeted fashion. Physico-chemical characterization by the UCONN team will be used to confirm this new QbD approach based on microstructure. Finally all these data are to be stored and shared in a reusable repository that can be leveraged by drug developers and the FDA for continued product development.

Extended-release drug products are patient centric and offer important advantages when compared with more commonly used immediate-release formulations. These advantages include less dose frequency, improved drug efficacy, and decreased risk of adverse effects.

In vitro release testing of complex long-acting products is essential in furthering product development, batch manufacturing, in vitro/in vivo correlations, bioequivalence studies for generics, and determination of shelf-life; however, the complexity of these formulations makes typical in vitro characterization techniques both time and cost prohibitive.

Dr. Andrew Clark, the project manager and Associate Director of Pharmaceutical Sciences at DigiM, commented on the contract, “The continuation of this collaboration between DigiM, UCONN, and the FDA is a powerful statement of the continued commitment towards advancing microstructure as a regulatory tool. DigiM’s development of imaging, AI-analysis, and advanced computational tools in understanding microstructure for microstructure (Q3) bioequivalence assessments will continue to be developed in close partnership with the regulators in order to provide the best guidance for the industry.”

Through this joint work, DigiM will build on existing frameworks to assess the impact of formulation and manufacturing parameters on microsphere quality and performance. This includes the use of AI-based models to correlate critical performance parameters with expected release performance and product quality. Further, the work performed under the contract aims to address the FY 2022 GDUFA science and research priority A4.

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