We are pleased to announce the ARMI | BioFabUSA Spring 2019 Project Calls. We encourage you to read this blog and the project call documentation, which is available on our community portal.
The first of four focus areas of the Spring 2019 Technical Project Call are centered around tissue maturation and bioreactor culture systems, which will allow for further development of bioreactor technology to address one or more aspects of the Equipment Development Activities related to bioreactors set forth in the ARMI | BioFabUSA Roadmap.
Many of the Development Activities are necessary to achieve the goal of a scalable, modular automated and closed tissue manufacturing line, such as the ARMI | BioFabUSA Tissue Foundry, that has a common core but is modular enough to allow for the manufacture of a wide variety of TEMP constructs. Compatibility of any proposed technology with the ARMI | BioFabUSA Tissue Foundry will be one of the key selection criteria.
The second of the four focus areas for the Spring 2019 Technical Project Call is targeted around measurement technologies, which currently require invasive manual sampling, which presents a risk to aseptic processing, can be vulnerable to inconsistent sample collection and analysis, and is not sustainable at commercial manufacturing scale. To achieve sustainable commercial scale manufacturing of tissue engineered products, there is a critical need for the development of robust non-invasive measurement technologies that enable real time monitoring and analysis of critical in-process parameters.
Development of an integrated process monitoring and control system would allow the implantation of a Quality by Design (QbD) and Process Analytical Technologies (PAT) principles within tissue engineered product development and manufacturing; this will lead to higher quality, more consistent products. All technologies are expected to be delivered in a form that is compliant with universal open standards protocols (e.g. IO-Link) to ensure compatibility with the BioFabUSA Tissue Foundry and other sensor and automated control systems in development by the ecosystem.
The third of four focus areas for the Spring 2019 Technical Project Call is focused on the development of a cell- and TEMP-specific chemically defined culture media, which will need to be optimized to maintain Critical Quality Attributes (CQAs) for pluripotent, primary, progenitor, and terminally-differentiated cell types.
Similarly, polystyrene has been used for cell culture for decades but is not the ideal substrate for cell culture of all cell types. Therefore, chemically defined, cell type and differentiation stage-specific culture substrates are needed. As with chemically defined culture media, these substrates need to be cost effective, control batch-to-batch variability, and control contamination risks.
And finally, the fourth of four focus areas of the Spring 2019 Technical Project Call is targeted around packaging, transport and storage. Cryopreservation of engineered tissues requires extreme diligence in cold chain management and is susceptible to transient warming. Preservation methods at ambient temperature would reduce risk and cost compared to traditional cryopreservation.
Additionally, tissues and organs shipped in liquid media will be susceptible to damage caused by slosh dynamics with the shipping container. Therefore, alternatives to shipping technologies in liquid media but maintain nutrient supply will have to be developed.
Successful awardees of the 2019 Tissue Foundry Project Call will collaborate with ARMI | BioFabUSA to adapt their manual TEMP fabrication process to the automated Tissue Foundry prototype manufacturing platform. The output of a successful project will be a modular, automated and closed manufacturing process that will be demonstrated on the Tissue Foundry platform to the ARMI | BioFabUSA members and its ecosystem.