Abstract

Scalable, Consistent and Cost-Effective: Addressing the Challenges of Manufacturing Human Cells, Tissues and Organs

Thomas Bollenbach, Chief Technology Officer, Advanced Regenerative Manufacturing Institute

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.