SPECIAL NOTICE
A -- Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII)
- Notice Date
- 5/24/2016
- Notice Type
- Special Notice
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911NF) RTP, PO BOX 12211, RESEARCH TRIANGLE PARK, North Carolina, 27709-2211, United States
- ZIP Code
- 27709-2211
- Solicitation Number
- W911NF-16-R-0021
- Archive Date
- 7/15/2016
- Point of Contact
- CHRISTOPHER JUSTICE, Phone: 919.549.4287
- E-Mail Address
-
christopher.d.justice4.civ@mail.mil
(christopher.d.justice4.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- NOTICE OF INTENT (NOI) FEDERAL AGENCY NAME: The Office of the Secretary of Defense (OSD), Office of the Deputy Assistant Secretary of Defense for Manufacturing and Industrial Base Policy (MIBP) via its Defense-wide Manufacturing Science and Technology Program AWARDING AGENCY NAME: U.S. Army Contracting Command- Aberdeen Proving Ground (RTP Division), 800 Park Office Drive, Suite #4229, Research Triangle Park, NC 27709 ANNOUNCEMENT TITLE: Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII) ANNOUNCEMENT TYPE: This is a Notice of Intent ANNOUNCEMENT NUMBER: W911NF-16-R-0021 1. GENERAL INTENT: The purpose of this Notice is to announce the U.S. Government's intent to seek competition for a seventh Manufacturing Innovation Institute (MII) to be led by the Department of Defense (DoD). The topic of this seventh DoD-led Institute is Advanced Tissue Biofabrication (ATB). The motivation for the ATB-MII is to increase U.S. competitiveness in advanced tissue biofabrication manufacturing by streamlining integrated testing technologies, reducing the barrier to entry for new inventors and encouraging insertion of disruptive technologies into multiple biotechnology sectors. 2. BACKGROUND: Of the eight overall Institutes currently established as part of the National Network for Manufacturing Innovation (NNMI) program, six are led by DoD and two are led by the Department of Energy (DOE). The DoD is leading MIIs focused on the following technology areas: (1) Additive Manufacturing; (2) Lightweight and Modern Metals; (3) Digital Manufacturing and Design; (4) Integrated Photonics; (5) Flexible Hybrid Electronics, and (6) Revolutionary Fibers and Textiles. The DOE is similarly leading MIIs within the NNMI program, with the first two focused on (1) Power Electronics; and (2) Advanced Composites. Additionally, DOE will soon announce the award of a third Institute entitled Smart Manufacturing: Advanced Sensors, Controls, Platforms and Modeling for Manufacturing. DOE's fourth Institute, Modular Chemical Process Intensification, is currently under solicitation. DOE also recently announced their fifth CEMI topic, Reducing EMbodied-energy And Decreasing Emissions (REMADE) in Materials Manufacturing. The Department of Commerce, National Institute of Standards and Technology (NIST), is currently running an open-topic competition for one or more MIIs. These eight existing Manufacturing Innovation Institutes, along with at least six additional institutes that are being planned, bring together industry, universities and community colleges, federal agencies, and state organizations to accelerate innovation by investing in industrially-relevant manufacturing technologies with broad applications. MIIs are intended to bridge the gap between basic research and product development, providing shared assets allowing access to cutting-edge capabilities and equipment, and creating an unparalleled environment to educate and train students and workers in advanced manufacturing skills. Each Institute serves as a regional hub of manufacturing excellence with a national impact. This MII can explore synergistic relationships with other DoD, DoE, and DoC institutes. MIIs provide the necessary innovation infrastructure to repair fragmented advanced manufacturing ecosystems, enabling the U.S. manufacturing sector to commercialize products. The technical focus area for the ATB-MII is driven by the diverse areas of science, engineering and technology involved in the development of biological substitutes for the repair, regeneration and mimicry of tissue or organ function which have led to a broad range of medical products. Some of these medical products have been approved by the FDA while others are under preclinical investigation or clinical evaluation. Industries focused on emerging tissue engineering, organ-on-a-chip and regenerative medicine are now a multi-billion dollar worldwide Research & Development effort, led by private investment in biotechnology startups and business units. Biological products such as cells, tissues, and organs are unique when compared to many other manufactured products. As living systems, they possess the ability to change and mature, or degrade, with time. Advances in cell biology and computer modeling, as well as in cell material sourcing and manufacturing, have provided ready access to and a better understanding of the basic building blocks of living tissue and organs. Breakthroughs in biofabrication, represent coordination between the materials, biological and engineering communities, have occurred over the past decade. These breakthroughs now enable three-dimensional constructs or tissues to be built with controlled cellular interfaces. Advances in micro- and nanofabrication and fluidic technologies now enable cell-material interactions to be engineered and controlled at unprecedented levels. Bioprinting technologies are being used to improve the scale, throughput and reproducibility of engineered tissues and cell-based assays. Automation and robotics are needed to increase rate, improve reproducibility, and reduce errors in multi-step manufacturing processes, a crucial component to scale-up and scale-out of these emerging technologies. Technologies ripe for significant evolution include, but are not limited to, high-throughput culture technologies, bioreactors, storage methodologies, non-destructive or minimally destructive test/sensors, and real-time monitoring/sensing technologies measuring the functionality, viability and chemical nature of engineered tissue constructs. 3. THIS INSTITUTE: The technical focus area for this Institute is represented by its title; the Advanced Tissue Biofabrication Manufacturing Innovation Institute (ATB-MII). The MII must bring together manufacturing, engineering, computer science, and research organizations from universities to established industrial concerns along with local, state, and federal government. The collaboration will enable post-delivery assurance of tissue identity, viability, function, and efficacy. Due to the building of three dimensional tissue analogs now being technically feasible, it is time to bridge the disruptive technologies forged through biofabrication innovation with the U.S. industrial and manufacturing sector. The biggest challenge to widespread availability for emerging tissue products is in common technologies, processes and standards to advance manufacturing, product testing, quality control and assurance, and product preservation. It is necessary to create and sustain an industrial commons to advance the standardization of tissue products for wide-spread use across industries (e.g., cell therapies, engineered replacement tissues, biopharmaceutical products and assays). These standards and processes will be developed in line with current and evolving FDA regulations. This institute will distinguish itself by bringing together diverse and synergistic biologic science and engineering disciplines with traditional manufacturing processes to accelerate industrialization of these emerging technologies. This Institute will bring together the diverse and currently fragmented collection of industry practices and institutional knowledge across many disciplines (cell biology, bioengineering, materials science, analytical chemistry, robotics, and quality assurance) to realize the promises of advanced tissue biofabrication. Scaling up to commercial level production of tissues will require manufacturing and process automation suitable for living cells (especially with respect to patient derived stem cells), as well as testing and preservation methods appropriate for tissue-based products with limited shelf-life and a narrow window of efficacy. The MII will use industrial manufacturing practices to reliably and reproducibly generate cells and biomaterials. Integrated biofabrication platforms will be developed to transform these standardized starting materials into novel and evolving end-product tissue designs. Additionally, automation and robotics will be designed and demonstrated to improve the rate and reproducibility of multi-step manufacturing processes. A crucial component to be developed in this MII is the successful commercialization of tissue-based products is non-destructive validation, which includes in-process and lot release testing sensitive to the unique challenges of manufacturing living tissues, such as limited analytical material and final product cost pressures. While the benefits of tissue-products are impactful for many critical public health needs, these advances in engineered cellular constructs have the potential for revolutionary benefits for the warfighter; including the direct repair or replacement of damaged tissues and organs; improving and accelerating the development cycle of medical countermeasures; and speeding innovation of new pharmaceutical products such as diagnostics, prophylactics, therapeutics and vaccines. When combined, these platforms, collaborations, innovations, and related infrastructure will create an industrial commons ecosystem ripe for technology transition and commercial manufacturing of in vitro and in vivo tissue products. Increased quality of sensing and manufacturing controls, led by this Institute, should facilitate meeting regulatory and manufacturing specifications including safety, efficacy, identity, purity, and potency. Additionally, non-destructive testing and precision medicine-optimized manufacturing will enable higher efficacy and operational efficiency. 4. AWARD INFORMATION: The U.S. Government intends to award and enter into a five to seven year Cooperative Agreement or Technology Investment Agreement and provide federal funding of, at least, $75 million that is to be matched or exceeded by funding from private industry and other non-federal sources (minimum 1:1 cost share). A Funding Opportunity Announcement (FOA) is expected to be released in mid- June 2016. There will be two Proposers' Days associated with this solicitation. The first of two planned Proposers' Days will be conducted at the ANSER Conference Center located at 5275 Leesburg Pike, Falls Church, Virginia on 17 JUNE 2016 (scheduled to end NLT 2 PM Eastern Time). A second Proposers' Day is being planned for another location on or about 23-24 JUNE 2016. Further details on both Proposers Days will be provided in an amendment to this NOI. The Proposers' Days are for informational purposes only, and attendance is not a prerequisite for submitting a proposal. 4. INQUIRIES: All questions may be directed via email using the title "NOI ATB-MII Questions" in the subject line to: Contracting Officer: Mr. Christopher Justice Email address: christopher.d.justice4.civ@mail.mil NOTE: All questions received and answers will be posted on www.manufacturing.gov 5. DISCLAMER: This NOI does not constitute a FOA. A future announcement will be posted that will provide FOA requirements for an assistance award.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/798330daad746f5d9ab52f22dd7dd113)
- Place of Performance
- Address: 800 Park Office Drive, Suite #4229, Research Triangle Park, North Carolina, 27709, United States
- Zip Code: 27709
- Zip Code: 27709
- Record
- SN04127881-W 20160526/160524235151-798330daad746f5d9ab52f22dd7dd113 (fbodaily.com)
- Source
-
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