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Manufacturing a Beta Cell Source to Advance Research and Development

Thomas Bollenbach, United States

Chief Technology Officer
Advanced Regenerative Manufacturing Institute

Overview

There is no cure for diabetes, and current treatments are insufficient in controlling blood sugars for many patients. Transplantation of insulin-secreting tissues promises to be an effective treatment, and some success has been realized by transplanting islets from cadaveric donors. However, isolated cadaveric islets are scarce and suffer from highly variable quality. A solution to this problem is to generate a renewable and consistent supply of SC-islets, at sufficiently large scale, from pluripotent stem cells for research and development and ultimately as a cell therapy. The Millman laboratory at WUStL has developed a robust, manual, bench-scale process for generating cell preparations with islet-like characteristics from iPSCs. We are automating and scaling this manual process on the ARMI|BioFabUSA Tissue Foundry manufacturing platform to generate a standardized preparation of well-characterized and quality controlled SC-islets for distribution across JDRF-funded laboratories. Ultimately, we plan to produce human SC-islets in a scalable, automated process under GMPs for human therapeutics.

Biography

Thomas Bollenbach, Ph.D. is Chief Technology Officer at the Advanced Regenerative Manufacturing Institute (ARMI)|BioFabUSA. Prior to joining ARMI, Tom served as Vice President of Research and Development at Harvard Apparatus Regenerative Technology, where he led the development of cell- and biomaterial-based tracheal, bronchial and esophageal implants. Tom joined the HART from Organogenesis, where he implemented and completed IND-enabling preclinical programs for bioengineered living skin, and maintained strong cross-functional interactions with Clinical Operations, Manufacturing and Business Units to provide scientific support to corporate strategies. Tom received his B.Sc. in Biochemistry from the University of Waterloo, a Ph.D. in Biochemistry from the University of Notre Dame.

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