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.

66 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.

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