Contract Manufacturing and Development Organizations (CDMO)

Contract Manufacturing and Development Organizations (CDMOs) deliver GMP-compliant scale-up, formulation, analytic development and sterile fill–finish for biologics, cell and gene therapies, medical devices and small molecules. CDMOs enable rapid tech transfer, quality systems and regulatory strategy to convert laboratory innovations into deployable medical countermeasures for military and civilian use.

Technical Challenges

  • Limited GMP capacity and surge capability for sterile biologics, viral vectors, and cell therapies

  • Reproducible scale-up from lab to commercial lot while preserving potency and safety

  • Complex aseptic fill–finish and cold-chain logistics for temperature-sensitive products

  • Regulatory and tech-transfer hurdles across multiple product types and jurisdictions

Emerging Opportunities

  • Modular, rapidly deployable manufacturing suites for austere or forward-deployed settings

  • Standardized assays, reference materials and analytical methods for military-relevant products

  • Integrated digital quality systems (e.g., PAT, electronic batch records, digital twins) to accelerate release

  • Sustained supply-chain resilience for critical raw materials and single-use consumables

Current and Emerging Technologies in Contract Manufacturing and Development Organizations (CDMO)

Single-use bioreactors and modular cleanrooms

Disposable bioreactor systems and prefabricated modular suites reduce contamination risk, shorten changeover times and permit rapid deployment or capacity expansion for biologics and viral vector production.

Continuous manufacturing and closed aseptic fill–finish

Continuous processes and closed-system aseptic filling increase throughput, improve batch consistency and enable more efficient use of cleanroom space for critical therapeutics.

Cell and gene therapy GMP platforms

Validated GMP workflows for autologous and allogeneic cell products, viral vectors and gene-modified therapies support translational pipelines for battlefield injuries and regenerative medicine.

Analytical development, PAT and digital twin

Advanced analytics, process analytical technology (PAT) and digital twin modeling accelerate method development, ensure product comparability and shorten regulatory timelines.

Lyophilization, formulation and cold-chain solutions

Stabilizing formulations, freeze-drying and validated cold-chain packaging extend shelf life and enable distribution to remote or austere environments.

Additive manufacturing and rapid prototyping for devices

3D printing and rapid prototyping support iterative device design, small-batch production of mission-specific tools and on-demand spare parts for medical systems.

Importance to Military Medicine

Rapid surge production for casualties and outbreaks

CDMOs provide scalable manufacturing to meet sudden demand for blood products, antitoxins, vaccines or antimicrobials during mass-casualty events or biological threats.

Support for prolonged and austere care

Stable formulations and deployable manufacturing reduce reliance on long supply lines, enabling sustained care in forward environments and delayed evacuation scenarios.

Readiness through supply-chain resilience

Diversified contract capacity and validated tech-transfer minimize single-point failures and maintain availability of mission-essential medical countermeasures.

Translational bridge from lab to field

CDMOs convert prototypes into deployable, regulated products—accelerating transition of MTEC-funded innovations into clinical use and operational capability.

Alignment with the MTEC Mission

Directly accelerates deployment of military-relevant medical technologies by providing GMP, quality systems and regulatory expertise required for fielding.

Supports MTEC’s broad portfolio—from trauma and infection to regenerative medicine—by enabling scalable manufacturing across diverse product classes.

Facilitates dual-use outcomes: military readiness and downstream civilian public-health benefits from the same development pathway.

Enables rapid response to DoD priorities—biodefense, prolonged care and trauma countermeasures—through vetted industry and academic capabilities.

Dual-Use (Military + Civilian) Applications

Vaccine and antiviral manufacturing for outbreak response and force health protection.

GMP production of cell therapies and biologics for trauma, wound healing and regenerative medicine.

Aseptic fill–finish and stabilized formulations for prolonged-field-care pharmaceuticals.

Rapid device prototyping and small-batch manufacturing for mission-specific medical tools and consumables.

Explore MTEC Members with Contract Manufacturing and Development Organizations (CDMO) Capabilities

MTEC members—industry CDMOs, academic GMP facilities and clinical partners—bring regulatory experience, validated manufacturing lines and DoD-focused translational expertise. Explore member profiles to find partners with sterile biologics, cell/gene therapy platforms, analytical development and deployable manufacturing solutions to accelerate military-relevant innovations into practice.

69 Members with Contract Manufacturing and Development Organizations (CDMO) capabilities.

Member
SIMETRI

SIMETRI is a woman-and-minority owned small business based in Winter Park, Florida, specializing in modeling, simulation, and training technologies. Founded in 2009, the company focuses on delivering innovative products and services that enhance the human experience and improve client outcomes through advanced training and program management analysis.

Member
IQVIA

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services for the life sciences industry. With a mission to accelerate innovation for a healthier world and a vision to power smarter healthcare for everyone, everywhere, IQVIA leverages unparalleled data, transformative technology, and deep healthcare expertise to drive better patient outcomes. Operating in over 100 countries with approximately 88,000 employees, IQVIA supports pharmaceutical, biotech, medtech, public health, and government organizations with a comprehensive portfolio of services and solutions. The company is recognized for its Connected Intelligence™, healthcare-grade AI, and commitment to sustainability, innovation, and evidence-based insights that shape the future of healthcare globally. IQVIA is also dedicated to reducing health inequities and driving sustainable change through innovation, collaboration, and data-driven solutions, partnering with organizations worldwide to address complex healthcare challenges.

Member
Advanced Regenerative Manufacturing Institute (ARMI)

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, nonprofit organization dedicated to advancing the bioeconomy of the United States. Its mission encompasses enhancing manufacturing, healthcare, and education and workforce development, aiming to create a scalable and effective manufacturing ecosystem for engineered cells, tissues, and organs.

Member
MK Strategy Group

MK Strategy Group is a certified Service-Disabled Veteran-Owned Small Business (SDVOSB) and a leading government contractor specializing in innovative healthcare solutions for military, government, and commercial sectors. With over two decades of experience, the company excels in medical procurement and facility development. MK Strategy Group bridges the gap between medical technology providers and government agencies, offering tailored, turnkey solutions that accelerate success in the government market. Their approach combines military precision, deep industry expertise, and a commitment to quality, innovation, and financial stability—enabling them to manage large-scale, complex projects with efficiency and reliability.

Member
BioPharma Connections

BioPharma Connections is an independent, woman-owned consulting firm founded in San Francisco in 2007, providing strategic business development, technical operations, regulatory, product development, and commercialization support to the life sciences industry. Serving pharmaceutical, biotechnology, medical device, and diagnostic companies globally, the firm specializes in facilitating connections between organizations, service providers, CROs, CDMOs, and investors—guiding clients from concept to commercialization, with deep expertise in regulatory compliance, emerging technologies, and diverse therapeutic areas.

Member
Harmac

Harmac is a global contract design and manufacturing organization specializing in single-use medical devices. With over four decades of experience, Harmac provides comprehensive services including product design and development, advanced manufacturing, automation, value engineering, quality assurance, and packaging and sterilization. The company is known for its operational excellence, regulatory compliance, and commitment to sustainability and community engagement. Harmac operates facilities across the United States, Ireland, and Mexico, supporting customers worldwide and across a range of clinical applications. ISO 13485 Certified and FDA Registered.

Member
DLH Holdings Corp.

DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. With over 3,200 employees, DLH is committed to solving complex problems faced by civilian and military customers, leveraging advanced technologies and methodologies to enhance health outcomes and operational readiness.

Member
Sunflower Therapeutics

Sunflower Therapeutics is a women-owned and led biotechnology public benefit corporation founded in 2018, dedicated to democratizing access to protein manufacturing worldwide. The company develops next-generation, automated, and fully-integrated protein manufacturing solutions that simplify the process from discovery to full-scale biomanufacturing. Their mission is to make high-quality, cost-effective therapeutics, vaccines, and protein-based products accessible globally, especially in low- and middle-income countries, by leveraging innovative technologies, sustainable practices, and intuitive equipment. Sunflower’s vision is to transform the global health landscape by enabling more medicines and protein products to reach patients and consumers everywhere. Their core technologies include efficient microbial hosts, data-driven process development, and modular manufacturing facilities, supporting agile, rapid, and cost-effective production cycles for a wide range of protein-based products.

Member
Ease Healthcare

Ease Healthcare (a registered DBA of MPS Medical, Inc.) is committed to advancing next-generation military medicine by accelerating access to clinically validated diagnostic tools, monitoring devices, and health and wellness technologies. As a trusted commercialization partner and distributor, the company empowers providers, organizations, and individuals with advanced solutions that support early detection, timely intervention, and improved health outcomes in both civilian and military settings. With a mission to make cutting-edge science and technology accessible to all, Ease Healthcare focuses on addressing critical health challenges such as 02 delivery, cancer, and cardiovascular disease —areas that directly impact force readiness and resilience. The company’s vision is to break barriers in healthcare by delivering innovative medical solutions that are affordable, accessible, and simple to use, regardless of economic or geographic limitations. In addition to bringing transformative technologies to market, Ease Healthcare provides turnkey services for medical device manufacturing and distribution, guiding partners from product development through regulatory compliance and successful deployment. By combining technical expertise with a dedication to accessibility, Ease Healthcare supports the Department of Defense’s priorities in preparing and protecting service members with next-generation healthcare solutions.

Member
EmergingDx

EmergingDx is dedicated to inventing, developing, and commercializing emerging technologies and products aimed at improving the quality of the human condition while positively impacting the environment and society. The company comprises a diverse team of world-class scientists, engineers, product designers, and business leaders with a proven track record of innovation and successful technology transition.

Member
PPD

PPD, a clinical research business of Thermo Fisher Scientific, is a leading provider of global contract research organization (CRO) solutions. The company is dedicated to helping clients accelerate the development of life-changing therapies through comprehensive drug development, laboratory, and lifecycle services. With a commitment to operational excellence and innovative technology, PPD empowers its customers to bring therapies to market faster and improve patient health. PPD has been recognized as an industry leader in clinical development digital transformation services and patient engagement digital transformation. With over 30 years of clinical leadership and a workforce of more than 30,000 employees globally, PPD has conducted over 2,100 trials in the past five years.

Member
Simbex

Simbex is a leading partner in medical device and consumer health product design and development, recognized for transforming complex ideas into commercially successful solutions. With a multidisciplinary team, Simbex excels in engineering, product design, software, data analytics, and commercialization strategy, supporting innovators from concept to market. Their mission is to deliver impactful medical devices and consumer health products that improve health outcomes and quality of life. Simbex is known for its holistic approach, deep regulatory expertise, and commitment to innovation and excellence in the health technology sector. The company is also active in thought leadership, regularly publishing regulatory and reimbursement updates, and hosting educational webinars for the MedTech community. Simbex maintains a robust Quality Management System compliant with ISO 13485 and FDA 21 CFR 820, ensuring high standards in product development. The company is also committed to supporting diversity in MedTech, including initiatives for women in the sector. Simbex's leadership and advisory team bring decades of experience in biomedical engineering, commercialization, regulatory affairs, and technology innovation, further strengthening its position as a trusted partner in the MedTech ecosystem.

Member
Prolucid Technologies Inc.

Prolucid Technologies Inc. specializes in custom software development for highly regulated industries, including medical and nuclear sectors. With over 17 years of experience and more than 1200 projects completed, Prolucid delivers robust, secure, and compliant software solutions. The company is ISO 13485 certified for medical software and adheres to CSA N299.1 and ISO 9001 standards for nuclear applications. Prolucid offers end-to-end services from project definition and planning to design, development, verification, and ongoing support, leveraging advanced technologies such as AI, ML, computer vision, and cloud infrastructure.

Member
Solventum

Solventum is a healthcare company dedicated to enabling better, smarter, and safer healthcare solutions. With a legacy of innovation, Solventum focuses on improving patient outcomes through advanced medical technologies, oral care solutions, health information technology, and purification and filtration systems.

Member
VETRUN LLC

VETRUN LLC is intentionally structured as a lean, project-focused organization designed to deliver complex, regulated medical products with speed, accountability, and cost efficiency. Rather than maintaining large internal departments for legal, regulatory, testing, manufacturing, and specialized engineering functions, VETRUN utilizes a distributed execution model, contracting with best-in-class service providers as required by each program. VETRUN works exclusively on one project at a time, enabling full leadership focus, rapid decision-making, and disciplined execution without competing internal priorities. This model allows VETRUN to assemble a tailored team of subject matter experts for each program, including legal counsel, FDA regulatory consultants, accredited testing laboratories, industry experts, contract manufacturers, and design and development partners. These relationships are not ad hoc. VETRUN has curated a robust network of U.S.-based (“Made in USA”) companies over more than 20 years, selecting partners with demonstrated experience in FDA-regulated medical devices, government programs, and high-reliability manufacturing. This long-standing network enables VETRUN to rapidly mobilize proven resources, scale capabilities as needed, and replace or augment services without disruption. By avoiding fixed overhead associated with large permanent staff and facilities, VETRUN maintains low indirect costs while preserving access to deep technical and regulatory expertise. This structure enhances flexibility, reduces financial risk, and allows resources to be applied directly to execution and milestone achievement rather than administrative burden. This execution model results in a company that is fast-moving, adaptable, and highly responsive, well-suited for time-sensitive programs requiring regulatory rigor, domestic manufacturing, and close coordination with Government stakeholders. VETRUN’s role is to serve as the integrator and accountable authority, ensuring that all partners operate cohesively toward a common objective while maintaining schedule discipline, quality compliance, and mission focus.

Member
Smith+Nephew

Smith+Nephew is a portfolio medical technology company focused on the repair, regeneration, and replacement of soft and hard tissue. The company aims to restore people's bodies and their self-belief by using technology to take the limits off living. With a commitment to medical education and improving patient outcomes, Smith+Nephew operates in over 100 countries and is dedicated to sustainability and community health. Their purpose is to promote health and wellbeing, not just through their products but also by ensuring a positive impact on society and the environment. Smith+Nephew is also committed to increasing diversity within the medical device industry through initiatives like the Orthopaedics for All global advisory board.

Member
xJect Medical

The company develops ultra-compact, prefilled syringe technology aimed at improving efficiency, safety, and scalability in injectable drug delivery. By fundamentally reengineering syringe architecture, the platform reduces device size, simplifies logistics, reduces waste, and enhances dose accuracy and safety. The technology targets both large-scale pharmaceutical manufacturing and distribution programs, particularly addressing bottlenecks in storage, cold chain transport, and rapid response for global healthcare delivery.

Member
CellBios

CellBios is a biotechnology company specializing in the design, development, and manufacturing of single-use bioprocessing and medical device solutions for healthcare, biotechnology, and regenerative medicine sectors. The company operates GMP and ISO-certified cleanroom facilities, offering a comprehensive portfolio of cryopreservation products, bioreactors, fluid management systems, advanced packaging, and specialty devices. By leveraging expertise in extrusion, molding, assembly, sterilization, quality control, and regulatory compliance, CellBios provides customized, scalable solutions to support blood transfusion, cell and gene therapy, biologics manufacturing, and clinical workflows.

Member
Draper

Draper is an independent nonprofit engineering innovation company with a legacy spanning over 90 years, dedicated to delivering transformative solutions for national security, prosperity, and global challenges. Renowned for its pioneering work in guidance, navigation, and control (GN&C) systems, Draper partners with government, industry, and academia to engineer advanced technologies in space, defense, biotechnology, and electronic systems. The company leverages multidisciplinary expertise, digital engineering, and a collaborative approach to provide field-ready prototypes, mission-critical systems, and innovative research. Draper’s mission is to ensure the nation's security and prosperity by delivering sustainable, cutting-edge solutions that address the toughest problems of today and tomorrow, while fostering an inclusive and diverse workforce. Draper also invests in the next generation of innovators through robust educational programs, including internships, co-ops, and the Draper Scholars Program, integrating academic research with real-world problem-solving.

Member
GTC 360° Advisors

GTC 360° Advisors is a mission-driven consulting firm specializing in business strategy, government contracts and grants, public affairs, and innovative solutions for complex policy and business challenges. Guided by a vision to simplify complexity and foster public-private partnerships, the firm is committed to building enduring relationships, developing innovative solutions, and pursuing good policy objectives. With a team of seasoned experts and a client-centric approach, GTC 360° Advisors delivers world-class advisory services that help organizations—from startups to Fortune 100 companies—navigate government procurement, drive growth, and achieve lasting impact. The company is recognized for its persistent and passionate approach, treating client causes as their own and building partnerships that unlock value and bring commercial innovation to life.

Member
Hatch PD

Hatch PD specializes in product design and development, offering a comprehensive range of services from concept to consumer. With a focus on innovation, efficiency, and quality, Hatch collaborates with clients to transform ideas into market-ready products while ensuring seamless integration of design and manufacturing processes. Their all-in-one approach integrates hardware, software, and firmware development, reducing time to market and enhancing product quality.

Member
Southwest Research Institute (SwRI)

Southwest Research Institute (SwRI) is a nonprofit research and development organization that provides independent, premier services to government and industry clients. Founded in 1947, SwRI is committed to advancing science and technology to benefit humanity, focusing on innovative solutions that improve human health and safety. With a diverse range of technical divisions, SwRI addresses complex challenges in various fields including mechanical engineering, materials, aerospace, automotive, biomedical, and more.

Member
GenVault

GenVault operates a secure, large-scale biorepository specializing in the storage, management, and logistics of biological and sensitive materials. Serving the life sciences, healthcare, government, and research sectors, GenVault offers robust, regulatory-compliant infrastructure engineered for resilience. The facility supports a comprehensive range of temperature-controlled storage and provides integrated sample management, cold chain logistics, and laboratory relocation services. Quality is maintained through internationally recognized certifications, advanced security systems, and a mature governance structure that emphasizes continuous compliance and operational transparency.

Member
Aspen Medical

Aspen Medical is a global leader in innovative healthcare solutions, specializing in delivering high-quality healthcare services in remote, challenging, and under-resourced environments. Established in 2003 in Australia, the company operates across Australia, the UK and Europe, the Middle East, North America, Africa, Asia, and the Indo-Pacific region. Aspen Medical is the only commercial organization in the world certified by the World Health Organization as an Emergency Medical Team for infectious disease outbreaks and trauma surgical operations. The company is committed to social responsibility, diversity, and inclusion, and is a certified B Corp and a signatory to the United Nations Global Compact. Aspen Medical partners with governments, NGOs, and private sector clients to provide end-to-end healthcare solutions, including hospitals and clinics, health advisory services, humanitarian and disaster response, aeromedical retrievals, occupational health, training, health technology, aged care, and medical equipment supply. The Aspen Medical Foundation, the company's registered charity, supports scholarships, community partnerships, and philanthropic initiatives, with a focus on empowering healthcare workers and communities.

Member
Combat SNS (Combat Medical Consulting, CMC)

Combat SNS (Combat Medical Consulting, CMC) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) dedicated to bridging the gap between innovative medical technologies and operational end users in the Department of Defense (DoD), Department of Veterans Affairs (VA), and other government agencies. With over 30 years of expertise in direct sales, government procurement, and market integration, CMC specializes in high-quality medical supply distribution, consulting, and product development. Their mission is to accelerate the adoption of advanced medical solutions, ensuring best-value procurement and broad impact across public health and defense sectors. CMC is recognized for its comprehensive approach, from market research and product validation to training, certification, and field deployment.

Member
Cepheid

Cepheid is a global leader in molecular diagnostics, dedicated to improving healthcare by developing, manufacturing, and marketing automated, easy-to-use molecular systems and tests. Their mission is to provide rapid, accurate, and actionable genetic testing for a wide range of infectious diseases, oncology, and human genetics. Cepheid's flagship GeneXpert System delivers scalable, sample-to-answer PCR testing for institutions of any size, supporting both centralized and decentralized care. The company is committed to expanding access to high-quality diagnostics worldwide, supporting public health initiatives, driving innovation in molecular testing, and advancing sustainability and responsible business practices.

Member
Lumen Bioscience, Inc.

Lumen Bioscience is dedicated to unlocking the full potential of biologic drugs by transforming their development, cost, and accessibility. Utilizing patented technology, Lumen aims to develop biologic drugs faster, safer, and more effectively than traditional methods, addressing diseases that have been neglected by conventional drug-making tools.

Member
Latham BioPharm Group

Latham BioPharm Group (LBG), now part of Sia Partners, is a consulting firm that provides specialized expertise across various life sciences sectors. The company is dedicated to helping innovative life sciences companies overcome complex scientific and business challenges. LBG offers a client-centric approach, adapting to the strategic direction and objectives of its clients to deliver meaningful analysis and quantifiable results. The firm is known for its scalable and flexible solutions that advance products and programs in the life sciences industry.

Member
Key Tech

Key Tech is a multidisciplinary product development firm specializing in medical, industrial, and consumer products. With over 20 years of experience, the company focuses on transforming complex technologies into intuitive products, ensuring compliance with regulatory standards while enhancing user experience. Key Tech's team of engineers, designers, and scientists work collaboratively to deliver innovative solutions across various sectors, including drug delivery, medical devices, and in vitro diagnostics. The company is also committed to environmental sustainability, integrating eco-friendly practices into its design and development processes.

Member
BioBridge Global

BioBridge Global is a nonprofit organization dedicated to saving and enhancing lives through the healing power of human cells and tissue. It operates a family of nonprofits including South Texas Blood & Tissue, QualTex Laboratories, GenCure, and The Blood & Tissue Center Foundation. The organization provides lifesaving therapies to patients and supports advances in advanced therapies, focusing on blood, cell, and tissue products, testing services, and the development of new therapies.

Member
ATD Emolda

ATD Emolda has been delivering innovative solutions for 40 years, specializing in the conversion and manufacturing of components and assemblies for industrial, medical, and pharmaceutical applications. The company has become a thought leader in advanced wound care materials, focusing on developing high-performance polyurethane foams and silicone adhesives.

Member
Versiti

Versiti is a nonprofit, 501(c)(3) blood health organization dedicated to improving patient lives and supporting healthcare partners through blood donation, innovative research, and advanced diagnostic testing. With locations across the Midwest, Versiti is a leader in blood health innovation, organ and tissue donation, and precision medicine. The organization is committed to enhancing patient care, advancing healthcare standards, and fostering a vibrant donor community. Versiti also supports education through scholarships and is recognized for its compliance and accreditations.

Member
Design West Technologies

Design West Technologies (DWT) is a nontraditional defense contractor founded in 1994, dedicated to providing innovative engineering solutions for warfighters. With nearly 30 years of experience, DWT specializes in weapon systems and CBRN (Chemical, Biological, Radiological, and Nuclear) detection and protection, operating from a facility in Southern California that is AS9100D/ISO 9001-2015 and ITAR certified.

Member
Viscus Biologics LLC

Viscus Biologics LLC specializes in product realization from ideation to high volume production, manufacturing components, devices, and products with natural polymer and extracellular matrix materials. The company aims to fulfill patient and market needs, improve quality of life, and restore tissue to a healthy state.

Member
ADS, Inc.

ADS, Inc. (Atlantic Diving Supply) is a leading value-added logistics and supply chain solutions provider serving all branches of the U.S. Military, federal, state and local government organizations, law enforcement agencies, first responders, partner nations, and the defense industry. Founded in 1997 in Virginia Beach, VA, ADS has grown into a Top 50 Department of Defense Contractor, recognized for its commitment to legendary customer service, broad procurement options, and innovative product and service offerings. The company is deeply rooted in its community, supporting military families, veterans, and first responders through scholarships, corporate giving, and ongoing service. ADS upholds the highest standards of business ethics, compliance, and quality, as demonstrated by its AS9100D, ISO 9001:2015, and ISO 14001:2015 certifications.

Member
ICON plc

ICON plc is a global provider of clinical, consulting, and commercial services, dedicated to helping pharmaceutical, biotechnology, and medical device companies bring new drugs and devices to market faster. The company offers a comprehensive range of services that span the entire lifecycle of product development, from early clinical phases to post-marketing. ICON is committed to delivering high-quality, harmonized data and innovative solutions to improve patient recruitment, retention, and engagement, while ensuring regulatory compliance and operational efficiency.

Member
MassBiologics

MassBiologics, part of UMass Chan Medical School, is the only nonprofit, FDA-licensed manufacturer of vaccines and biologics in the United States. With over 100 years of experience, it is dedicated to improving public health through the research, development, and production of biologic products, including vaccines and monoclonal antibodies.

Member
Ceres Nanosciences, Inc.

Ceres Nanosciences, Inc. is a privately held company based in Northern Virginia, specializing in the development and commercialization of Nanotrap® hydrogel particle technology. Their mission is to deliver innovative products powered by Nanotrap Technology to address life science needs and provide better patient outcomes. Ceres' products enable the capture, concentration, and preservation of low-abundance analytes from diverse biological and environmental samples, supporting applications in diagnostics, research, and public health surveillance. The company is ISO 9001:2015 certified and collaborates with leading research institutions, public health agencies, and industry partners to advance global health security and biosecurity. Ceres has established a national network of Wastewater-based Epidemiology Centers of Excellence and has received significant funding from the NIH RADx initiative and other organizations to expand its impact in underserved communities. Their technology is widely adopted for wastewater-based epidemiology, proteomics, and nucleic acid analysis, with a strong focus on supporting public health monitoring, early detection of infectious diseases, and environmental bio-surveillance.

Member
University of California, Irvine

The UCI Office of Research is dedicated to supporting and enhancing the creative and scholarly activities of UCI faculty and researchers. It provides central administrative support for research programs, ensuring compliance with regulations and fostering an environment conducive to research and innovation.

Member
Instant Systems

Instant Systems specializes in the design and manufacture of single-use sterile systems for cell and gene therapy, regenerative medicine, tissue banking, and related bioprocessing applications. The company offers a wide range of customizable solutions for cell culturing, fluid management, media and waste containment, magnetic cell separation, and sterile filtration, with a focus on maintaining process integrity from production through delivery. Their products support closed-system workflows, scalability, and integration into existing manufacturing and research environments.

Member
BioTechnique®

BioTechnique® is a full-service Contract Research Development and Manufacturing Organization (CRDMO) specializing in sterile injectable fill-finish services. With a commitment to quality and innovation, BioTechnique® aims to enhance healthcare outcomes worldwide by providing high-quality life-saving products and maintaining the highest standards in pharmaceutical manufacturing.

Member
MRIGlobal

MRIGlobal is a renowned Midwest research institute based in Kansas City, dedicated to improving the overall health, safety, and well-being of people everywhere. With over 80 years of experience, MRIGlobal specializes in diagnostics, pharmaceutical sciences, vaccines and therapeutics, global health surveillance, infectious disease, public health, warfighter protection, agriculture, and management and operations. The organization is committed to using science and technology to create solutions for a safer, healthier, and more sustainable world.

Member
Creare

Creare is a leading innovator in technology and product development, specializing in engineering research and development services. With over 50 years of experience, Creare combines sophisticated analytical methods with creative engineering to solve complex challenges across various sectors, including biomedical systems, cryogenics, fluid dynamics, and advanced manufacturing. The company is dedicated to delivering innovative solutions that enhance product functionality, reduce costs, and accelerate time-to-market for its clients. Technology commercialization has been a key part of Creare’s mission since its founding in 1961, leading to significant revenue generation through licensing and spin-offs.

Member
ORF Biologics, Inc.

ORF Biologics, Inc. is a biotechnology company based in Tiffin, Iowa, specializing in the design, development, and manufacturing of advanced biologics for research and therapeutic applications. With over 45 years of industry experience, the company pioneers next-generation biologics, focusing on custom and off-the-shelf solutions for pharmaceutical and biotech companies. ORF Biologics is committed to accelerating scientific discovery through innovative protein engineering, synthetic biology, and rigorous quality control, serving critical fields such as infectious disease, neurodegeneration, regenerative medicine, and biosecurity.

Member
Henry M. Jackson Foundation for the Advancement of Military Medicine

The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is dedicated to advancing military medicine through research and innovation. For over 40 years, HJF has been a trusted partner in managing research awards, ensuring compliance, and facilitating the transition of medical innovations from concept to commercialization. The foundation supports a wide range of research areas, including infectious diseases, cancer, and mental health, with a focus on improving the health and readiness of military personnel and civilians alike.

Member
Kindeva Drug Delivery

Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.

Member
Emergent BioSolutions

Emergent BioSolutions is dedicated to developing, manufacturing, and delivering medical countermeasures that address public health threats. With a mission to protect and enhance life, the company focuses on innovative vaccines and therapeutics to combat critical health challenges, including the ongoing opioid crisis.

Member
RQMIS

RQMIS (Regulatory/Quality Management Information Source) is a global regulatory consultancy dedicated to guiding medical device, pharmaceutical, nutraceutical, and cosmetic companies through the complex pathways of product development, regulatory approval, and market sustainability. Established in 1996, RQMIS operates from strategic locations in Amesbury, Massachusetts (USA); Barcelona, Spain; and London, United Kingdom, enabling comprehensive support for clients worldwide. RQMIS emphasizes personalized service, ensuring accessibility and responsiveness to client needs. The firm's mission is straightforward: to bring clients' products to market efficiently and maintain their success through ongoing compliance and strategic support.

Member
University at Buffalo (UB)

The University at Buffalo is a leading public research university and flagship of the SUNY System, recognized for its innovative research and commitment to societal impact. It aims to transform scientific and technological breakthroughs into global impact, addressing complex challenges through interdisciplinary collaboration.

Member
Prospect Life Sciences

Prospect Life Sciences is a medical device development and manufacturing partner offering integrated, end-to-end solutions from concept through global market fulfillment. The company provides comprehensive capabilities in research and design, product development, manufacturing transfer, scalable production, and regulatory compliance, leveraging ISO 13485:2016-certified and FDA-registered quality management systems. With facilities in the USA and Costa Rica, the company serves as a strategic partner for both early-stage and established organizations, enabling efficient, compliant, and scalable innovation in the medical device sector.

Member
Kamat Pharmatech

Kamat Pharmatech is a US-based pharmaceutical contract development organization specializing in formulation development, regulatory strategy, and the advancement of complex generics, injectable, lyophilized, oral liquid, and topical drug products. With over a decade of experience and scientific leadership in lyophilization, injectables, topicals, and regulatory pathways, the company serves as a partner for pharmaceutical firms seeking expertise in development, characterization, and US-FDA compliance.

Member
Brinter Inc

Brinter is a pioneering US-based MedTech firm focused on revolutionizing tissue engineering through the development of 3D bioprinted biocomposite regenerative implants, known as BioMods™, which aim to restore damaged tissue and replace conventional implants, launching in orthopedics/tendons and ligaments. The company driven by a team of visionary entrepreneurs and leading bioscientists and engineers.

Member
Cook MyoSite

Cook MyoSite, a subsidiary of Cook Group, has been advancing human muscle cell technology since 2002. Operating under ISO 9001:2015-certified quality standards, we specialize in primary human skeletal muscle-derived cells and fibro-adipogenic progenitors sourced from healthy donors and individuals with neuromuscular, metabolic, and rare disorders. Our offerings include custom cell procurement, specialized media formulations, and contract manufacturing services—supporting both academic research and clinical development in regenerative medicine. Beyond research tools, Cook MyoSite is pioneering autologous muscle-derived cell therapies. Our investigational product, iltamiocel, is currently in a Phase III clinical trial for fecal incontinence, demonstrating our commitment to translating cell-based science into real-world solutions. With expertise in GMP manufacturing, analytical testing, and tailored partnerships, we empower collaborators to accelerate innovation in musculoskeletal and neuromuscular health worldwide.

Member
DesignPlex Biomedical LLC

DesignPlex Biomedical specializes in the prototyping, design development, and contract manufacturing of medical devices. The company is dedicated to improving patient outcomes through innovative medical solutions, focusing on quality and collaboration with clients to bring their ideas to life.

Member
Minnesota Wire

Minnesota Wire is a privately owned, industry-leading custom wire and cable manufacturer based in St. Paul, Minnesota, with over 50 years of experience. The company specializes in designing, developing, and manufacturing high-performance wire, cable, and interconnect assemblies for mission-critical applications across medical, aerospace, defense, and industrial markets. Renowned for its commitment to innovation, quality, and engineering excellence, Minnesota Wire leverages advanced R&D, vertically integrated manufacturing, and a customer-centric approach to deliver life-saving connections and cutting-edge solutions. The company is AS9100, ISO9001, IPC-620, and MIL-STD certified, and is recognized for its contributions to technological advancement, community impact, and sustainability. Minnesota Wire is now a woman-owned business, marking a new era of growth and inclusivity.

Member
Corscience

Corscience is a German-based medical technology development and manufacturing provider specializing in advanced solutions for defibrillation, patient monitoring, and vital sign acquisition. The company supports OEMs and medtech startups internationally with expertise across R&D, regulatory affairs (including MDR and FDA compliance), quality management, lifecycle management, and technical consulting. Their track record includes the delivery of complex, safety-critical systems and robust integration of electronic, software, and mechanical components in medical devices.

Member
Medical College of Wisconsin

The Medical College of Wisconsin (MCW) is dedicated to transforming healthcare through innovative education, research, and patient care. With a focus on academic medicine, MCW aims to improve the health of communities by fostering a collaborative learning environment that integrates medical education with groundbreaking research and comprehensive patient care.

Member
Soter Bio

Soter Bio is a specialized biologics Contract Development and Manufacturing Organization (CDMO) supporting mRNA, cell therapy, gene therapy, and plasmid DNA production. The company provides process development, technology transfer, CMC strategy, validation, and regulatory readiness to help innovators advance therapies from development through commercialization. Soter Bio focuses on translating complex science into robust, scalable, and compliant manufacturing solutions for advanced therapeutic modalities.

Member
SiO2 Materials Science

SiO2 Materials Science specializes in developing and manufacturing advanced polymer primary packaging solutions for the pharmaceutical, biotechnology, and diagnostics industries. The company’s technology integrates the barrier properties of glass with the durability and precision of engineered polymers, providing packaging that protects against leachables, extractables, breakage, and gas permeation. With a focus on research and innovation, and a significant patent portfolio, SiO2 offers solutions tailored to complex drug formulations and challenging storage conditions.

Member
International Fabric Machines

International Fabric Machines appears to be in the process of establishing its online presence, as the domain is not yet connected to a website. The company may be involved in the fabric machinery industry, but specific details about its mission and vision are not available at this time.

Member
Proxima CRO

Proxima CRO is a leading Contract Research Organization (CRO) that specializes in providing innovative solutions for medical devices, drugs, and diagnostics. With a focus on agility and efficiency, Proxima aims to de-risk biotech and MedTech programs, enhance regulatory clearance chances, and optimize capital efficiency. The company is dedicated to supporting clients through every stage of clinical development, ensuring timely and cost-effective results.

Member
Inertia

Inertia is an innovation-driven firm delivering end-to-end design, engineering, prototyping, and manufacturing for medical, clean tech, industrial, safety, and advanced hardware industries. Distinguished by their tightly integrated evidence-based approach—including strategy, human factors, regulatory and advanced manufacturing—they execute at every phase: from early startup product validation through SMB innovation acceleration, to full-scale manufacturing for startup and large enterprises. Their unique differentiator lies in the seamless integration of product strategy, development, and manufacturing under one roof—enabling clients to optimize quality, achieve rapid speed-to-market, and realize measurable cost and risk reductions. With robust quality systems, client-centered project management, and a reputation for transparency, Inertia consistently sets new standards for product innovation and commercialization.

Member
The Geneva Foundation

The Geneva Foundation is a 501(c)3 nonprofit established in 1993, dedicated to advancing military medicine through research, development, and education. With a commitment to ensuring optimal health for service members and the communities they serve, Geneva collaborates with various partners to drive innovative medical research and improve healthcare outcomes.

Member
Ginkgo Bioworks

Ginkgo Bioworks is a leading synthetic biology company that partners with organizations across various industries to harness the power of biology. Their mission is to make biology easier to engineer, enabling the development of innovative solutions in agriculture, biopharma, industrial biotechnology, and more. Ginkgo's platform combines advanced automation, data analytics, and a vast library of genetic assets to accelerate research and development, optimize production processes, and reduce costs. They are revolutionizing industrial processes with biological solutions that lower costs, open new markets, valorize waste streams, and create sustainable supply chains.

Member
Tensentric

Tensentric is a contract design and manufacturing firm focused solely on medical device, in vitro diagnostic, and advanced therapy markets. We're ISO13485 certified and FDA registered to help our clients bring their new technology and products to market.

Member
Axiom Management Solutions

Axiom Management Solutions is a veteran-owned business offering consulting and service support across all stages of medical device development. Axiom's core philosophy: Early-stage medtech innovators deserve to own their development journey without the burden of heavy overhead or restrictive partnerships. Axiom empowers developers to bring their vision to life with precision, flexibility and expert support. The company specializes in helping innovators navigate regulatory requirements, develop prototypes, establish quality management systems, and take medical devices from concept to commercialization.

Member
Scientific and Medical Affairs Consulting, LLC (SMAC)

Scientific and Medical Affairs Consulting, LLC (SMAC) is an integrated drug development and life cycle management support company. SMAC provides nimble, data-driven scientific, medical affairs, and commercial expertise to bridge early development through commercialization for biotechnology and pharmaceutical companies. With a team of seasoned professionals, SMAC delivers tailored strategies and solutions to optimize drug development, regulatory submissions, and commercialization, aiming to accelerate innovative therapies and improve patient outcomes.

Member
CuriRx

CuriRx is a minority woman-owned Contract Research, Development, and Manufacturing Organization (CRDMO) based in Massachusetts. The company provides comprehensive solutions for drug development with expertise in bioprocessing, formulation development, analytical testing, and manufacturing support. CuriRx offers services across the therapeutic development spectrum, including customized solutions, collaboration, cutting-edge analytical methods, and process optimization to accelerate client projects from discovery to clinical and commercial stages.

Member
PDV MedTech

PDV MedTech, previously known as Phoenix DeVentures, is a U.S.-based company founded in 2001 specializing in medical device design, development, and ISO 13485:2016-certified contract manufacturing. Acquired by INDO-MIM in 2025, the company offers end-to-end solutions from prototyping to high-volume production with capabilities in injection molding, 3D printing, fabrication of mold tools, and cleanroom assembly. PDV MedTech supports startups and innovators in commercializing their devices through regulatory support, quality management, and scalable manufacturing across locations in California, Colorado, and Utah.

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Safi Biotherapeutics

Next-Generation Manufactured Red Blood Cells for Extended Battlefield Blood Supply: Safi Biotherapeutics

Safi Biotherapeutics is developing manufactured red blood cells (mRBCs) with extended shelf life to improve battlefield transfusion readiness and emergency trauma care.

Non-Invasive Glymphatic (GF) Monitoring and Recovery Optimization for Warfighter Cognitive Readiness

Applied Cognition is developing non-invasive glymphatic monitoring and recovery technologies to enhance warfighter cognitive readiness, resilience, and sleep recovery.

Moberg Analytics

Moberg Analytics – Advanced Brain Monitoring & Critical Care Informatic

Moberg’s platform unifies brain monitoring data for faster, precise treatment of severe brain injuries in military and civilian care.

University of California San Francisco

TemPredict: AI-Driven Wearable Monitoring for Early Illness Detection and Warfighter Readiness

TemPredict: AI wearables detect early illness and health risks to support warfighter readiness.

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