ARMI's mission is to make practical the large-scale manufacturing of engineered tissues and tissue-related technologies, to benefit existing industries and grow new ones. In help achieve this mission, one of the BioFabUSA program's manufacturing goals is to make practical end-to-end automated biofabrication lines. These lines would ideally incorporate process analytical technologies ("PATs") to aid in the design, analysis and control of biomanufacturing processes through measurement of parameters that are essential to tissue engineering and regenerative medicine. ARMI | BioFabUSA envisions a single manufacturing line that includes the use of multiple bioreactors that can be used for any tissue and include basic non-invasive sensors for real-time monitoring of samples. It is with the goal of a system like this in mind that the Spring 2018 Technical Project Call and TissueFoundry Technology Call are based.
Spring 2018 Technical Project Call
The first of two focus areas of the Spring 2018 Technical Project Call is centered around measurement technologies, which will allow for the development of non-invasive measurement technologies that enable real time monitoring and analysis of growing cells and tissues. Current technologies require invasive manual sampling, which not only presents a risk to aseptic processing but is also inconsistent processing and analysis and is not sustainable at a commercial manufacturing scale.
Non-invasive sensors would need to monitor and analyze in-process manufacturing and able to be integrated into flow paths or sample paths of single use systems or mountable on or within production systems. Ultimately, non-invasive real time monitoring would allow for precise, acute control of processes during manufacturing, storage and transport via feedback to process control and automation systems. Proposals should include the methods employed to ensure the technology achieves a high level of measurement quality and productivity.
The second of the two focus areas for the Spring 2018 Technical Project Call is targeted around data capture, storage and management. Successful design and implementation of modular and scalable manufacturing processes will require the capture, storage, management and integration of large volumes of data from diverse sources (multi-omics). Early development of said technologies will require integration of multiple and various data sets – a challenge shared across the medical field.
Capture of the data during manufacturing scale-up and lifecycle management will require a scalable electronic platform that allows simultaneous sampling from multiple inputs, potentially at different frequencies, and sends the data to a secure server to index the data for retrieval. Data processing would leverage integration tools developed for multi-omics management and analysis and a common IT structure that will be used to house all data from engineered tissues manufactured using different automation methods or tools.
Funded Spring 2018 Technical Projects will be expected to deliver a process, a prototype technology in an operational state, or both, that address a common manufacturing gap and therefore enable engineered tissue manufacturing by a significant portion. These processes and prototype technologies will be demonstrated in the context of manufacturing of one or more tissue engineered and regenerative medicine (TERM) products.
TissueFoundry Technology Call
In conjunction with the newly developed technologies regarding measurement as well as data capture, storage and management, a separate Tissue Foundry Technology Call will also be taking place. The long-term goal of this project is to build a modular, flexible, GMP-compliant, closed and fully automated manufacturing line for engineered tissues. The prototype line will be built in the short-term and serve to highlight capability gaps to refine BioFabUSA’s focus areas as well as future technology project calls.
The TissueFoundry Technology Call will focus on the identification and collection of existing prototype and otherwise off-the-shelf technologies that may be integrated into a prototype modular manufacturing system for engineered tissues. The line is designed to have 5 modules, which will focus on seed pool culture, cell harvest and wash, scaffold fabrication, scaffold seeding and culture, and final packaging of the product. Ultimately, the manufacturing line will be a GMP-compliant line used for process validation, early phase clinical manufacturing and will form the basis for technology transfer activities.