News | October 24, 2023

Germfree Laboratories And Title21 Health Solutions Transform Cell And Gene Therapy Manufacturing With Decentralized Innovation

Source: Germfree
Germfree's Mobile Cleanroom Platform Powered by Title 21 Health Solutions
Germfree's Mobile Cleanroom Platform Powered by Title 21 Health Solutions

Germfree Laboratories and Title21 Health Solutions team up to revolutionize healthcare manufacturing, putting patient access at the forefront through decentralized innovation.

Ormond Beach, FL - Germfree Laboratories and Title21 Health Solutions unveil a groundbreaking mobile manufacturing platform seamlessly integrated with an advanced manufacturing operating system, set to redefine decentralized point-of-care (POC) cell and gene therapy production.

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

"Together, Germfree and Title21 Health Solutions envision a future where cell and gene therapies transcend geographical boundaries, ensuring universal patient access regardless of location or circumstances," says Carol Houts, Chief Strategy Officer of Germfree Labs.

Germfree Labs, recognized experts in cleanroom technology and manufacturing, specialize in the development of cutting-edge infrastructures engineered to obviate constraints. These designs enhance facilities to ensure seamless production, overcoming geographical constraints, and effectively address the regulatory challenges confronting the biotech industry today. Over the course of more than a decade, Germfree has delivered mobile and modular facility solutions on a global scale, including over 110 cleanroom installations within the United States alone.

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.

Germfree and Title21 Health Solutions have joined forces to offer established products and services that seamlessly integrate and enhance current technologies. Germfree's mobile and modular cleanrooms, combined with Title21's digital platform, empower healthcare institutions and drug innovators to adopt decentralized manufacturing, expanding patient access at the POC in underserved areas.

A Vision for the Future:

"Together, Germfree and Title21 Health Solutions envision a future where therapies transcend geographical boundaries, ensuring universal access regardless of location or circumstances. Our commitment to state-of-the-art facility infrastructure aligns with Title21's OS longstanding 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.

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

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 remains resolutely committed to providing innovative solutions that significantly improve patient access to life-changing therapies. Germfree is backed by the healthcare growth equity investor, EW Healthcare Partners.

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.

About Title21 Health Solutions:

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 health care 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 -

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.

Source: Germfree