The Tissue Foundry

The Tissue Foundry is a methodology that involves picking apart manual processes, designating automation modules for unit operations, creating custom-engineered components, integrating the modules into an automated and closed process and confirming that the process delivers critical quality attributes. BioFabUSA’s Tissue Foundry is a working demonstration system of SMAC—for Scalable, Modular, Automated and Closed—manufacturing.

What is the Tissue Foundry?

Current cell, tissue and organ manufacturing practices are not scalable, consistent or cost-effective. At BioFabUSA, we are redefining the biofabrication industry’s manufacturing technology and processes to bring projects out of laboratories and into manufacturing facilities.

The Vision of the Tissue Foundry

The vision for the Tissue Foundry is to create a tissue-manufacturing platform that is scalable, modular, automated and closed—and that uses sensors and automation to control critical process parameters and therefore limit variability. SMAC is where quality-by-design manufacturing comes to life.

Scalable

Manufacturing technologies must enable manufacturing from research scale to commercial production so that process output can be scaled up, down and out with minimal impact on product quality and demand for expensive comparability studies is low.

Automated

To reduce process-related variability, automation can make objective, measurement-based decisions during a process and allow technicians to work with machinery at a strategic level to ensure consistency.

Modular

Manufacturing systems and even processes need to be flexible to adapt to unique and changing variables, as well as to accommodate equipment and technology changes without disrupting the supervisory automation and data acquisition infrastructure.

Closed

A functionally closed manufacturing system increases sterility assurance and avoids the need for expensive clean-room spaces.

History of the Tissue Foundry

We built the Tissue Foundry to demonstrate the power of this vision, conduct process development work and leverage advanced deep tissue characterization to smooth the transition to manufacturing in a Good Manufacturing Process environment—with a well-defined process ready to scale.

The prototype Tissue Foundry represents the best of today’s technologies, serving as a test bench and a way of identifying new, unforeseen challenges. The technology-development projects we are funding are aimed at filling gaps in those areas.

We are partnering with several member organizations advancing high-impact, regenerative medicine products to demonstrate the Tissue Foundry concept for their process while conducting parallel, high-throughput process development to validate process changes necessary to transition from manual, small-scale manufacturing to SMAC manufacturing.

For more details on the Tissue Foundry: