Germfree, a cleanroom services and equipment firm, has partnered with non-profit organization Caring Cross to create a 'decentralized, point-of-care manufacturing model' for cell and gene therapies (CGTs). The partnership will combine Germfree’s cleanrooms with Caring Cross’s manufacturing technology.

Germfree will provide advanced hardware and digital platforms to ensure quality control, while Caring Cross will develop the therapeutic product, provide the workflows and manufacturing protocols, and train doctors and healthcare organizations in the production of these therapies.

It advances Caring Cross’ collaboration with the Brazilian government’s Fundação Oswaldo Cruz (Fiocruz) foundation to establishing local chimeric antigen receptor (CAR-T) cell-therapy manufacturing.

Through a point-of-care manufacturing model, the partnership will make gene therapies available in remote and underserved locations.

According to Germfree, the point-of-care manufacturing model involves producing advanced therapies like CAR-T cells directly at or near the healthcare facility where they will be administered. This approach eliminates the need for complex logistics associated with transporting sensitive biological products and significantly reduces production times and costs. By utilizing modular cleanrooms and streamlined manufacturing processes, therapies can be tailored to individual patients more efficiently, making treatments more accessible and affordable.

BioProcess Insider spoke to Carol Houts, chief scientific officer, Germfree, about the partnership with Crossing Care, point-of-care manufacturing, and the future of CGTs.

BioProcess Insider (BPI): How did the collaboration between Germfree and Caring Cross come about, and what were the key factors that led to this partnership?

Carol Houts (CH): The partnership between Germfree and Caring Cross took shape over three years ago, rooted in a shared vision to decentralize the production of therapies, particularly in underserved regions. Germfree brought its expertise in deploying modular cleanroom infrastructure for research or cGMP manufacturing on a global scale. Together, we have developed the Caring Cross modular platform, merging innovative CAR-T production methods with Germfree’s ability to deliver scalable, compliant facilities worldwide, addressing critical healthcare challenges of cost and accessibility.

BPI: How does the point-of-care manufacturing model address the current challenges of high costs and long manufacturing times in CGTs?

CH: This model tackles these challenges by decentralizing production and bringing manufacturing closer to the point of care. By cutting down on logistical expenses tied to centralized production and long-distance transportation, we can significantly lower costs. The streamlined and robust processes developed by Caring Cross further reduce production time and expenses, making these therapies more affordable and accessible to a broader range of patients.

BPI: What specific advancements in Germfree’s modular cleanroom infrastructure make it suitable for decentralized, point-of-care manufacturing?

CH: Germfree's modular cleanrooms are built with flexibility and scalability at their core, making them an ideal platform for decentralized manufacturing. We've successfully deployed mobile cleanrooms to over 110 sites across the US and more than 200 cleanrooms and laboratories worldwide. These cleanrooms can be rapidly deployed and tailored to fit various manufacturing processes, maintaining the high levels of sterility and containment necessary for advanced therapies like CAR-T cells.

BPI: How will Caring Cross's manufacturing protocols be adapted for use in mobile cleanroom units?

CH: Caring Cross’s manufacturing protocols, which are already designed for simplicity and cost-effectiveness, will be adapted to fit within Germfree’s mobile cleanroom units. These units provide a controlled environment that meets the stringent requirements for CAR-T cell production. The protocols will likely focus on streamlining processes to ensure they can be executed efficiently within the space constraints of a mobile unit, while maintaining high standards of quality and safety.

BPI: What is the expected cost reduction in manufacturing CAR-T and other CGT products through this point-of-care model?

CH: The cost reduction we're seeing with the point-of-care manufacturing model is significant—estimates suggest we could bring the cost of producing CAR-T therapies down to as low as $35,000 per dose in Brazil, compared to the typical $350,000 or more in the US and Europe. This tenfold decrease is because of the simplified production process, localized manufacturing, and the use of more cost-effective technologies. However, we won't fully understand the extent of these savings until the decentralized model is more widely implemented and we can analyze the results more comprehensively in practice.

BPI: What are the long-term goals of this partnership, and how do you plan to measure its success over time?

CH: The long-term goals of our partnership with Caring Cross are to expand access to CAR-T therapies not just across Latin America, but also in the US and other regions worldwide. We're focused on reducing manufacturing costs and establishing a scalable, decentralized production model that can be replicated globally. Success will be measured by how many patients we can treat, the extent to which we can lower costs, and our ability to implement this model in different regions. Additionally, we'll be looking at the impact on public health systems, like the Brazilian SUS, in terms of cost savings and patient outcomes, as key indicators of the partnership’s effectiveness.

BPI: How will the partnership be funded, and what financial resources will be required to scale the decentralized manufacturing model globally?

CH: The partnership between Germfree and Caring Cross is funded through a combination of public and private investments. To scale the decentralized manufacturing model globally, substantial financial resources will be needed, including investments in infrastructure, technology transfer, and training programs. The success of the pilot project in Brazil will serve as a proof of concept to attract further funding for expansion into other regions.