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The Islet Product, Planning for Trials, and Manufacturing

Tuesday April 25, 2023 - 10:15 to 11:30

Room: Riverfront

S7

.4 Scale - up manufacturing; how to do it or not so easy?

Tom Bollenbach, United States

Chief Technology Officer
Advanced Regenerative Manufacturing Institute

Biography

Thomas Bollenbach, Ph.D. is Chief Technology Officer at the Advanced Regenerative Manufacturing Institute (ARMI)|BioFabUSA. Tom is responsible for providing leadership to the institute’s technical programs, which include the development of enabling platform technologies for human cell and tissue manufacturing, Quality by Design-based process development methodologies for scalability and GMP-readiness, and development and demonstration of modular, automated and closed manufacturing systems. 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 HART from Organogenesis, where he implemented 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.

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