Germfree Laboratories and Title21 Health Solutions Revolutionize Cell and Gene Therapy Manufacturing Through Decentralized Innovation

Press Release

For Immediate Release

[Ormond Beach, Florida, 20-October-2023] - Pioneering healthcare companies Germfree Laboratories and Title 21 Health Solutions are joining forces in a transformative partnership. Together, they introduce a groundbreaking mobile manufacturing platform, powered by the cutting-edge Title21 digital operating system (OS), poised to redefine cell and gene therapy manufacturing and dramatically reduce time-to-market for life-saving therapies.


Germfree Labs and Title21 Health Solutions introduce a groundbreaking mobile manufacturing platform poised to revolutionize decentralized cell and gene therapy production. This collaboration not only speeds up the time required for therapy production but also hints at an upcoming product launch

Decentralized Manufacturing Redefined:

This partnership focuses on decentralized manufacturing, an innovative approach to traditional centralized models, aiming to overcome bottlenecks and streamline access to therapy delivery.

Germfree Labs, experts in cleanroom technology and manufacturing, design cutting-edge infrastructures to eliminate constraints, positioning facilities for seamless production, transcending geographical boundaries, and ensuring consistent access to life-saving treatments.

Title21 Health Solutions, the industry leader in cell and gene therapy software, regulatory compliance, and quality management, provides an advanced, all-in-one operating platform as the backbone of this decentralized manufacturing ecosystem, ensuring compliance to the highest of industry standards, increasing production capacity, and enhancing product quality and safety.

Empowering Patients with Tomorrow's Cures:

The ultimate goal is to empower patients with unprecedented access to future cures. By decentralizing manufacturing, these industry leaders aim to significantly reduce time-to-market, offering hope to patients grappling with life-threatening diseases.

A Vision for the Future:

Together, they envision a future where therapies transcend geographical boundaries, ensuring universal access regardless of location or circumstances.

"We are thrilled to join forces with Title21 Health Solutions in our mission to revolutionize cell and gene therapy manufacturing. Our commitment to state-of-the-art facility infrastructure aligns with Title21's OS expertise, enabling decentralized manufacturing to reduce therapy costs and expand access," says Carol Houts, Chief Strategy Officer of Germfree Labs.

"At Title21 Health Solutions, we've always focused on delivering innovation and ensuring quality and regulatory compliance. Partnering with Germfree Labs allows us to extend our impact in the cell and gene therapy space. Together, we are building the future of patient-centered healthcare," adds Lynn Fischer, CEO of Title21 Health Solutions.

About Germfree Labs:

Germfree Laboratories has become a globally recognized authority in cutting-edge critical environment equipment, cleanrooms, and laboratories for over six decades. The company has consistently led the way in pioneering cleanroom design and manufacturing, serving the biopharmaceutical, healthcare, and research sectors. Germfree is backed by the healthcare growth equity investor, EW Healthcare Partners.

Since 2014, Germfree has successfully deployed more than 100 mobile cleanrooms to hospitals and pharmaceutical companies, enabling the production of USP 797/800 compounded drugs and cGMP-manufactured products. Germfree remains resolutely committed to providing innovative solutions that significantly improve patient access to life-changing therapies. www.germfree.com

About EW Healthcare Partners: With over $4 billion raised since inception, EW Healthcare Partners is one of the oldest and most respected private healthcare investment firms and seeks to make growth equity investments in fast growing commercial-stage healthcare companies in the pharmaceutical, medical device, diagnostics, and technology-enabled services sectors in the United States and in Europe. Since its founding in 1985, EW Healthcare Partners has maintained its singular commitment to the healthcare industry and has been a long-term investor in over 150 healthcare companies, ranging across sectors, stages and geographies. The team is comprised of over 20 senior investment professionals with offices in New York, London and Houston.  https://www.ewhealthcare.com/


About Title21 Health Solutions- www.title21.com. Title21 Health Solutions is an ArchiMed portfolio company. ArchiMed is a leading healthcare industry-focused growth equity enterprise based in New York and Lyon, France. Since 2001, Title21 Health Solutions has been dedicated to delivering easy-to-use, flexible, and integrated technology to support healthcare providers and the health sciences to achieve compliance, gain efficiencies and ensure high quality, ultimately, to support improvement in patient safety and care. The sole focus is developing technology to meet the specific needs of healthcare and life sciences firms, resulting in comprehensive solutions that are flexible to evolving business and regulatory requirements. Through the years, their partnerships with industry leaders have road-mapped their innovations to continue to meet the dynamic needs of the markets they serve.


About ArchiMed - www.archimed.group. With offices in the US, Europe, and Singapore, ArchiMed is a leading investment firm focused exclusively on healthcare industries. Its mix of operational, medical, scientific, and financial expertise allows ArchiMed to serve as both a strategic and financial partner to North American and European healthcare businesses. Prioritized areas of focus include biopharmaceutical products & services, life science tools, medical devices & technologies, diagnostics, health technologies & software and consumer health. ArchiMed helps partners internationalize, acquire, innovate, and expand their products and services. Over the last twenty years, ArchiMed’s leadership team has directly managed and invested in over eighty small to large-size healthcare companies globally, representing over €50 billion of combined value. ArchiMed manages €5 billion across its various funds.



The partnership between Germfree Labs and Title21 Health Solutions signifies a significant milestone in cell and gene therapy manufacturing. Embracing decentralized production, these industry giants accelerate the availability of life-saving therapies, offering hope to patients worldwide.


For media inquiries, please contact:

Germfree Laboratories:

Lauren Miller, Content Marketing Manager



Title21 Health Solutions:

Ron Reha, Senior Manager, Strategy and Innovation


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