Advanced Regenerative Manufacturing Institute

What Advanced Regenerative Manufacturing Institute does

The Advanced Regenerative Manufacturing Institute (ARMI) is a Department of Defense-sponsored Manufacturing Innovation Institute and member-based nonprofit organization founded in 2016, headquartered in Manchester, New Hampshire. ARMI's mission is to enable scalable, secure, and cost-effective production of regenerative medicine technologies, advancing the U.S. bioeconomy through three core programs: BioFabUSA (a public-private partnership of 170+ members across industry, academia, government, and nonprofits), ARMI BioIndustries (a fee-for-service development, manufacturing, and commercialization arm), and NextFab (a foundry for American biotechnology focused on national health security). The institute's technical platform centers on SMAC (Scalable, Modular, Automated, Closed) manufacturing systems, embodied in the Tissue Foundry demonstration platform and complemented by the Deep Tissue Characterization Center (DTCC) for analytical services and BioFabConsulting for regulatory strategy.

ARMI generates revenue through multiple streams: tiered annual BioFabUSA membership subscriptions, contract manufacturing and consulting services via ARMI BioIndustries and BioFabConsulting, and grant-funded workforce development programs (BioTrek, BioFab Startup Lab, BioFab Trekker Camp). The organization has secured approximately $236.5 million in cumulative government funding across three major rounds: an $80M DoD grant in 2017, a $56.5M EDA Build Back Better Regional Challenge grant in 2023, and a $100M DoD investment in 2024. Major strategic partners include Rockwell Automation (whose CEO Blake Moret sits on ARMI's Board), Thermo Fisher Scientific, and Advanced Solutions Life Sciences, with member companies such as Safi Biotherapeutics, Pluristyx, and Kenai Therapeutics advancing cell and gene therapy programs through ARMI's ecosystem. ARMI serves therapeutic developers, academic and research institutions, the Department of Defense and military health organizations, and supply chain technology vendors across the regenerative medicine value chain.

Name

Advanced Regenerative Manufacturing Institute

Legal name

Advanced Regenerative Manufacturing Institute, Inc.

Website

https://armiusa.org

Company type

Private

Founded year

2016

Operating status

Operating

Headcount range

11–50 employees

Short description

ARMI is a DoD-sponsored nonprofit Manufacturing Innovation Institute that advances U.S. regenerative medicine biomanufacturing through its BioFabUSA public-private partnership, ARMI BioIndustries contract services, and SMAC manufacturing platforms serving therapeutic developers, academia, and government.

Ownership category

akta.pro rank

Product category

Regenerative Medicine Biomanufacturing

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Analytical Laboratory Instrument Manufacturing (334516)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Engineering Services (8711)

akta.pro primary industry

Process Development & Tech Transfer Services (upstream/downstream) (HLAAAKAF)

akta.pro secondary industries

Health, Pharmaceuticals & Medical Devices Regulatory Cooperation (BPADANAJ), Instrumentation, Controls & Automation Engineering Consulting (BPAHAIAM), Engineering & Technology Institutes (Comprehensive) (EDAHAEAA)

Keywords

• Regenerative manufacturing
• Biomanufacturing services
• Tissue engineering
• Cell therapy manufacturing
• Bioprocess development

Headquarters

HQ city

Manchester

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Membership Fees: ARMI operates as a member-based nonprofit organization. Organizations join BioFabUSA to become part of a national network driving the future of regenerative medicine and advanced manufacturing. Membership provides access to collective expertise, shared resources, project participation, and collaboration opportunities.
2. Contract Manufacturing and Consulting Services: ARMI BioIndustries provides fee-for-service development, manufacturing, and regulatory consulting to therapy developers. Services include process development, analytical services through the Deep Tissue Characterization Center, clinical manufacturing, and regulatory strategy support.
3. BioFabConsulting: Regulatory consulting services offered to members and potentially non-members. Initial consultations are free for members, with fee-based engagements for comprehensive consulting support covering regulatory strategy, FDA submissions, and clinical trial design.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels6 records

Core offering

ARMI is a DoD-sponsored Manufacturing Innovation Institute that operates a public-private consortium (BioFabUSA) and a fee-for-service development and manufacturing arm (ARMI BioIndustries) to advance scalable production of cell, tissue, and organ-based products. It provides shared infrastructure, SMAC (Scalable, Modular, Automated, Closed) manufacturing technology demonstrated via the Tissue Foundry, the Deep Tissue Characterization Center for analytical testing, BioFabConsulting for regulatory strategy, and workforce/apprenticeship programs. The institute sells memberships, manufacturing and regulatory services, and accelerator access to biotech developers, academic researchers, DoD stakeholders, and supply chain partners.

Product overview

ARMI operates as a multi-program organization advancing the U.S. bioeconomy through regenerative manufacturing. The core programs include BioFabUSA (public-private partnership with 170+ members driving cell, tissue, and organ manufacturing), ARMI BioIndustries (full-service development, manufacturing, and commercialization), and NextFab (biotechnology foundry). Key enabling platforms include the Tissue Foundry (SMAC manufacturing methodology), Deep Tissue Characterization Center (DTCC), and BioFabConsulting (regulatory services). Supporting programs include BioFab Startup Lab (accelerator), BioTrek (workforce education), ReGen Valley (workforce training center), and the Build Back Better Regional Challenge grant. Together, these offerings create an integrated ecosystem from research through commercialization.

Differentiator

Problem solved

Functional benefit

Brands

• BioFabUSA: A public-private partnership program with more than 170 members driving technical and strategic leadership in development and manufacturing of cell, tissue, and organ-based products.
• ARMI BioIndustries
• NextFab
• ReGen Valley

Products and services

• BioFabUSA A public-private partnership program of ARMI with over 170 member organizations from industry, academia, government, and nonprofits that drives technical and strategic leadership in the development and manufacturing of cell, tissue, and organ-based products.
• ARMI BioIndustries Full-service development, manufacturing, and commercialization arm of ARMI that offers process development, deep tissue and material characterization, clinical manufacturing, and regulatory compliance support for engineered cells, tissues, and organs.
• NextFab The first Foundry for American Biotechnology, established to strengthen the nation's health security and accelerate biotechnology innovation by supporting the development of technologies for health-related threats, everyday medical care, and domestic advanced biomanufacturing capacity.
• Tissue Foundry A working demonstration system of SMAC (Scalable, Modular, Automated, and Closed) manufacturing for cells, tissues, and organs that serves as a test bench for identifying process challenges and demonstrating advanced biomanufacturing using sensors and automation.
• Deep Tissue Characterization Center (DTCC) Analytical service that empowers innovators with critical insights necessary to manufacture high-quality regenerative products and meet rigorous safety and therapeutic efficacy requirements, applying Quality by Design (QbD) principles and control strategies.
• BioFabConsulting Regulatory consulting service for regenerative medicine covering regulatory strategy review, FDA submissions, preclinical and clinical trial design, quality systems review, and regulatory training through bootcamps.
• BioFab Startup Lab A 6-month accelerator program that provides newly formed and emerging companies with mentorship, funding opportunities, and access to BioFabConsulting to translate biotechnology innovation into commercial products.
• BioTrek Education and workforce development program designed to inform, attract, inspire, and recruit the biofabrication workforce of tomorrow through camps, workshops, and extended learning opportunities.
• ReGen Valley Workforce training center and community development initiative in the Manchester Millyard, part of the Build Back Better Regional Challenge, aimed at creating jobs and training local workers for careers in regenerative manufacturing.
• Biofabrication Technician Apprenticeship Apprenticeship program designed to provide the skills and knowledge essential for careers in the biofabrication industry.
• Advanced Manufacturing Technician Apprenticeship Program Two-year program combining college-level coursework and on-the-job training to prepare individuals for careers in advanced manufacturing.
• BioTrekker Camp Week-long biotechnology science camp at SEE Science Center in Manchester, NH, open to students ages 11-14 with a capacity of approximately 15 participants; registration fee is $325 per student with various discounts.

Quantifiable outcome

• ARMI BioFabUSA members have access to over 170 organizations across industry, academia, government, and nonprofits
• +2 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles4 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

25 partnerships are on record, tiered core, major, portfolio and minor.

• Safi BiotherapeuticscoreStrategic or Co-development Partner · 8 January 2026Safi Biotherapeutics and ARMI | BioFabUSA completed successful technical transfer of Safi's 10-liter scale manufactured red blood cell (mRBC) production system to GMP manufacturing conditions. This milestone positions Safi to produce mRBCs at clinically meaningful scale for military and civilian transfusion needs, targeting initial IND submission in 2027 for sickle cell disease chronic transfusion therapy.
• Breakthrough T1DmajorStrategic or Co-development Partner · 17 November 2025Collaboration between member Pluristyx and Breakthrough T1D (formerly JDRF) to develop immune-cloaked and safety switch-enabled allogeneic cell line for Type 1 Diabetes therapies.
• City of ManchestercoreStrategic or Co-development PartnerLed the Southern New Hampshire BioFabrication Cluster proposal selected for Build Back Better Phase 2 grant. Coalition aims to make Manchester the epicenter of the biofabrication industry with estimated creation of ~7,000 direct jobs and ~37,250 total jobs.
• University of New HampshirecoreStrategic or Co-development PartnerKey coalition partner in Build Back Better Regional Challenge. Partnership includes UNH Manchester Biotechnology Innovation Center providing priority access to office and lab spaces for startup companies. Also partner in STEM from the Start program.
• Southern New Hampshire UniversitymajorStrategic or Co-development PartnerCoalition partner in Build Back Better Regional Challenge focused on workforce development and educational programming for the biofabrication ecosystem.
• Southern New Hampshire Planning CommissionmajorStrategic or Co-development PartnerCoalition partner in Build Back Better Regional Challenge contributing planning and regional development expertise to support biofabrication ecosystem growth.
• Agnos TherapeuticsportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• Aegle TherapeuticsportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• Cellf-BioportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• CytotheryxportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• VascugenportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services. Led by Dr. Dave Mann, member of Leadership Advisory Council.
• Advanced Silicon GroupportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• Detact DiagnosticsportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• LikardaportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• NovagynportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• Pro-TheraportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• ReconstructportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab associated with Wyss Institute at Harvard, receiving mentorship and startup support services.
• RyTek MedicalportfolioStrategic or Co-development PartnerPortfolio company in BioFab Startup Lab, receiving mentorship, consulting, and startup support services.
• Rockwell AutomationcoreTechnology or IntegrationKey technology partner providing automation expertise. CEO Blake Moret serves on ARMI Board of Directors. Rockwell's industrial automation capabilities support the Tissue Foundry SMAC manufacturing platform development.
• Thermo Fisher ScientificcoreTechnology or IntegrationKey industry partner with Dr. Mark Powers from Thermo Fisher serving on the Leadership Advisory Council, contributing expertise in bioprocessing and manufacturing scale-up.
• Advanced Solutions Life SciencescoreTechnology or IntegrationPartner on Tissue Foundry development, providing robotic arm-based platform technology for automated regenerative manufacturing processes. President & CEO Michael Golway serves on BioFab Startup Lab Advisory Board.
• SEE Science CentermajorStrategic or Co-development PartnerPartnership for biotechnology education through the BiologYou exhibition introducing visitors to DNA structure and function, and hosting BioTrekker Camp programs.
• Girl Scouts of the Green and White MountainsminorStrategic or Co-development PartnerCollaborative partnership to increase exposure to biofabrication field through Girl Scouts Biofabrication Patch program.
• Kenai TherapeuticsmajorStrategic or Co-development PartnerARMI ecosystem member advancing RNDP-001 for treatment of Idiopathic Parkinson's Disease. Received $8M grant from CIRM. CEO Howard Federoff serves on Leadership Advisory Council.
• PluristyxmajorStrategic or Co-development PartnerARMI ecosystem member with Benjamin H. Fryer on Leadership Advisory Council. Collaborating with Breakthrough T1D on Type 1 Diabetes cell therapy.

Scale indicators8 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Centre for Commercialization of Regenerative Medicine (CCRM): Canadian-based consortium accelerating the commercialization of regenerative medicine and cell/gene therapies through industry-academic partnerships, process development, and manufacturing services. CCRM operates as ARMI's closest international peer, pursuing a comparable mission to bridge academic discovery and industrial-scale biomanufacturing.
• Cell and Gene Therapy Catapult: UK government's cell and gene therapy innovation accelerator, offering manufacturing process development, clinical and commercial manufacturing, regulatory expertise, and a large industry-academic consortium. Operates with a comparable public-private partnership structure to ARMI's BioFabUSA, addressing the same manufacturing translation gap for advanced therapies.
• ATCC (American Type Culture Collection): Nonprofit biological resource center providing authenticated cell lines, microbial cultures, and bioprocessing services to the regenerative medicine and life sciences ecosystem. Comparable in mission and nonprofit structure, with similar emphasis on standardization, quality, and serving as a trusted intermediary between research and industrial applications.
• RoslinCT: Scotland-based cell therapy contract development and manufacturing organization (CDMO) specializing in induced pluripotent stem cell (iPSC) therapies. Directly comparable to ARMI BioIndustries in offering process development, GMP manufacturing, and analytical services for advanced cell therapies, though commercially focused rather than consortium-based.
• Regenerative Medicine Development Organization (ReMDO): North Carolina-based nonprofit focused on advancing regenerative medicine through workforce development, technology innovation, and industry collaboration. Operates a similar model to ARMI's BioTrek and BioFabUSA programs in building talent pipelines and ecosystem coordination, with comparable workforce training and education program emphasis.

Broad incumbents

• Lonza: Swiss-headquartered global CDMO with major cell and gene therapy manufacturing capabilities across process development, viral vector production, and clinical/commercial GMP manufacturing. Represents the established commercial scale against which ARMI BioIndustries competes, though serving a much broader pharmaceutical services market rather than specializing in biofabrication.
• Catalent: Major global CDMO offering cell therapy, gene therapy, and biologics development and manufacturing services, including the Paragon Gene Therapy acquisition. Comparable to ARMI BioIndustries as a process development and GMP manufacturing partner, but operating as a diversified commercial CDMO rather than a consortium-led nonprofit.
• WuXi Advanced Therapies: Unit of WuXi AppTec providing cell and gene therapy contract development and manufacturing services, including viral vector, cell therapy, and plasmid DNA production. Represents another well-capitalized incumbent offering services that overlap with ARMI BioIndustries, though at broader commercial scale and across a wider range of therapeutic modalities.

Others

• Bio-Techne: Major supplier of reagents, proteins, and cell culture products used widely across the regenerative medicine and cell therapy ecosystem. Functions as a critical enabling technology vendor to ARMI members and BioFab Startup Lab portfolio companies, supplying the building blocks for biofabrication workflows rather than competing directly.
• StemCell Technologies: Canadian-based supplier of cell culture media, reagents, and tools for stem cell research and regenerative medicine applications. Comparable ecosystem participant as a critical inputs supplier to biofabrication workflows, but does not directly compete with ARMI's process development, manufacturing, or consortium services.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/armiusa
• Instagraminstagram.com/armibiofabusa

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries3 records

Funding overview

Funding rounds1 record

Investors1 record

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Advanced Regenerative Manufacturing Institute