Germfree Laboratories and Title21 Health Solutions have unveiled a groundbreaking mobile manufacturing platform seamlessly integrated with an advanced manufacturing operating system, set to redefine decentralised point-of-care (POC) cell and gene therapy production.
This partnership focuses on decentralised manufacturing, an innovative approach to traditional centralised models, aiming to overcome bottlenecks and streamline access to therapy delivery.
Germfree Labs, recognised experts in cleanroom technology and manufacturing, specialise 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.
Our commitment to state-of-the-art facility infrastructure aligns with Title21's OS longstanding expertise, enabling decentralised manufacturing to reduce therapy costs and expand access
- Carol Houts, Chief Strategy Officer of Germfree Labs
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 decentralised 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 decentralised 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 decentralised 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," added 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 decentralised production, these industry experts accelerate the availability of life-saving therapies, offering hope to patients worldwide.
