Manufacturing road map for tissue engineering and regenerative medicine technologies

Abstract

The Regenerative Medicine Foundation Annual Conference held on May 6 and 7, 2014, had a vision of assisting with translating tissue engineering and regenerative medicine (TERM)-based technologies closer to the clinic. This vision was achieved by assembling leaders in the field to cover critical areas. Some of these critical areas included regulatory pathways for regenerative medicine therapies, strategic partnerships, coordination of resources, developing standards for the field, government support, priorities for industry, biobanking, and new technologies. The final day of this conference featured focused sessions on manufacturing, during which expert speakers were invited from industry, government, and academia. The speakers identified and accessed roadblocks plaguing the field where improvements in advanced manufacturing offered many solutions. The manufacturing sessions included (a) product development toward commercialization in regenerative medicine, (b) process challenges to scale up manufacturing in regenerative medicine, and (c) infrastructure needs for manufacturing in regenerative medicine. Subsequent to this, industry was invited to participate in a survey to further elucidate the challenges to translation and scale-up. This perspective article will cover the lessons learned from these manufacturing sessions and early results from the survey. We also outline a road map for developing the manufacturing infrastructure, resources, standards, capabilities, education, training, and workforce development to realize the promise of TERM.

Figure 1.

Manufacturing workflow for allogeneic and autologous TERM products. Illustrated is a workflow that details the manufacturing process in the top panel for allogeneic or “off-the-shelf” and autologous TERM therapies. The middle panel shows the workflow for decellularized scaffolds. The bottom panel depicts the workflow for bioprinting. Abbreviations: CT, computed tomography; MRI, magnetic resonance imaging; TERM, tissue engineering and regenerative medicine; Tx, treatments.

Figure 2.

An outline of the tissue engineering and regenerative medicine (TERM) industry survey (left). We conducted a survey to gain insight into TERM products that are either already on the market or are in development and what roadblocks companies faced in developing these products with a particular focus on manufacturing criteria as shown (A–I). The table (right) summarizes these preliminary results from the TERM survey (based on 7 industry responses about 11 products, received before the submission of this manuscript). The frequency of responses for each rating is shown (where 1 indicates very severe, 2 indicates severe, 3 indicates somewhat of a problem, 4 indicates mild problem, and 5 indicates not much of a problem). The asterisk indicates that the average is weighted. The lower the value, the higher the severity. Abbreviations: Avg., average; FDA, Food and Drug Administration; RBLK, roadblock; SOP, standard operating procedure.

Figure 3.

Manufacturing road map for TERM technologies. Depicted is an envisioned road map that will help address current manufacturing challenges plaguing the field. Abbreviation: TERM, tissue engineering and regenerative medicine.