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SELECTBIO Conferences Biofabrication & Biomanufacturing 2022

Thomas Bollenbach's Biography

Thomas Bollenbach, Chief Technology Officer, Advanced Regenerative Manufacturing Institute (ARMI, BioFabUSA

Thomas Bollenbach, Ph.D. is Chief Technology Officer at the Advanced Regenerative Manufacturing Institute (ARMI)|BioFabUSA. Tom is responsible for providing leadership to ARMI’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. 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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Scalable, Consistent and Cost-Effective: Addressing the Challenges of Manufacturing Human Cells, Tissues and Organs

Tuesday, 22 March 2022 at 09:30

Add to Calendar ▼2022-03-22 09:30:002022-03-22 10:30:00Europe/LondonScalable, Consistent and Cost-Effective: Addressing the Challenges of Manufacturing Human Cells, Tissues and OrgansBiofabrication and Biomanufacturing 2022 in

Decades of basic research into the biological basis and therapeutic value of stem cells, tissues and organs has laid the technical foundations for a revolution in medicine. However, that revolution continues to lie just around the corner due mainly to challenges associated with scalable, consistent, cost-effective manufacturing. The mission of BioFabUSA is to make practical the scalable, consistent and cost-effective manufacturing of cells, tissues and organs by investing strategically an $80MM award from the Department of Defense in collaboration with nearly 180 industry, academic, not-for-profit and government stakeholders. These stakeholders are driving the industry towards scalable, modular, automated and closed (SMAC) manufacturing systems, which are being developed and demonstrated in the context of ligament, skin, skeletal muscle, bone, pancreatic islet, and retinal progenitor epithelial cell production processes. These SMAC systems are being augmented by technology development projects, designed to fill gaps and augment current bioprocess equipment with platforms for novel non-destructive sensors, platforms for chemically-defined media formulation and for new types of preservation methods. These systems are also supported through the institute’s deep tissue characterization core, which enables big data-driven Quality by Design process development for scalability and GMP-readiness. Given the regulatory constraints of translating these products to patient use, BioFabUSA complements its technology development activities with a robust regulatory program, which includes a public private partnership agreement with CBER. This PPP is paving the way to smoother regulatory pathways for complex advanced therapies.

Add to Calendar ▼2022-03-21 00:00:002022-03-22 00:00:00Europe/LondonBiofabrication and Biomanufacturing 2022Biofabrication and Biomanufacturing 2022 in