Ormond Beach, Fla. and Gaithersburg, Md., August 21, 2024 – Germfree, a pioneering leader in modular cleanroom infrastructure and services, and Caring Cross, a forward-thinking 501(c)(3) nonprofit committed to accelerating the development of advanced medicines and ensuring patient access to transformative therapies, today announced a new partnership to transform access to cell and gene therapies (CGTs). The collaboration is set to make cellular gene therapies more available to patients by creating a decentralized, point-of-care manufacturing model that combines Germfree’s cutting-edge mobile cleanroom units with Caring Cross’s innovative manufacturing technologies and pipeline of cellular gene therapy products.

Most CGTs are one-and-done therapies made by modifying a patient’s own cells, which have been widely approved to treat – and often cure – patients with intractable diseases like late-stage blood cancers, as well as undertreated chronic diseases like sickle cell disease. Despite its best efforts, the biopharma industry has been unable to reach all eligible patients because of the way the drugs are made. Until now, they have been too expensive, take too long to manufacture, and were only available to patients in affluent regions.*

The partnership between Germfree and Caring Cross builds on three years of preparation, including a pilot project with Brazil’s Fundação Oswaldo Cruz (Fiocruz) to launch local CAR-T manufacturing next year. Germfree will lead the facility innovation, providing advanced hardware and digital platforms to ensure robust quality control. Meanwhile, 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.

By leveraging these capabilities, the partnership will create a comprehensive, end-to-end solution for point-of-care manufacturing of CAR-T and other cellular gene therapies.

“We are focused on making these transformative therapies more accessible by manufacturing CGT products at the point-of-care, near or at clinical centers where patients receive treatment,” said Boro Dropulić, Executive Director and co-founder of Caring Cross. “With a modest investment, clinical centers and affiliated organizations can leverage their existing capabilities to produce CAR-T and other CGT products sustainably and affordably. Our goal is to empower these centers to provide life-saving therapies at a fraction of the current cost.”

By leveraging a point-of-care manufacturing model, Germfree and Caring Cross are poised to make cellular gene therapies available in remote and underserved locations, bridging gaps in current industry capabilities.

“This is a transformational moment for the field, where sustainable models that have long been theoretical will finally begin to impact patients,” said Carol Houts, Chief Strategy Officer at Germfree. “We often hear that innovation leads to affordability, but patients have been suffering while they wait. The technology for mobile cleanrooms with stringent quality management systems is ready. This partnership aims to inspire the industry to advance and demonstrate that CAR-T and other cell therapies can be made accessible globally, regardless of regional wealth disparities.”

A network of organizations dedicated to advancing point-of-care manufacturing, regulatory approval, and product provision is essential to creating equitable, affordable, and sustainable cures worldwide. To learn more about partnering with Germfree and Caring Cross, visit www.germfree.com and www.caringcross.org.

About Germfree

Germfree is a global leader in the design, manufacture, and maintenance of modular cleanroom environments. With decades of global expertise in serving the biopharmaceutical industry, Germfree specializes in providing advanced solutions that enhance the safety, efficiency, and sustainability of critical healthcare manufacturing processes. Germfree is continuing to invest in cleanroom design and manufacturing solutions and is committed to providing innovative solutions, with the goal of improving patient access to critical medicines. GermFree is backed by the healthcare growth equity investor, EW Healthcare Partners. www.germfree.com

About Caring Cross

Caring Cross is a 501(c)(3) nonprofit dedicated to accelerating the development of advanced medicines and ensuring access to cures for all patients, everywhere. To enable its mission, Caring Cross is developing technologies and therapeutic candidates to improve the accessibility, affordability, and applicability of advanced medicines like CAR-T therapy and stem cell gene therapy. Caring Cross founded Vector BioMed, a for- profit vector contract development and manufacturing organization (CDMO), specializing in rapid lentiviral vector manufacturing solutions, to provide the industry a source of affordable high-quality GMP Lentiviral vectors. For more information on Caring Cross visit https://caringcross.org/. For more information on Vector BioMed visit https://vectorbiomed.com/.

* Germfree and Caring Cross: Addressing Critical Barriers to Access

Germfree and Caring Cross are partnering to tackle the three biggest obstacles preventing patients from accessing these life-saving therapies: cost, geography, and time.

Cost: The current cost of CAR-T cell therapies starts at $350,000, with some patient-specific therapies exceeding $3 million. Not only does this put them out of reach for many today, it is difficult to imagine how any health system in the world could sustainably afford these therapies for all the patients who need them – particularly as the field expands into new indications.

Germfree and Caring Cross aim to significantly reduce these costs by developing a point-of-care manufacturing model and partnering directly with local governments and institutions. This can lead to fewer expensive steps and opportunities for waste, making these therapies less expensive and more accessible to patients. In addition, Caring Cross’s mission as a non-profit is to leverage its decades of CAR-T development experience to create affordable therapies.

Geography: To get access today, patients need to reach a specialized facility for blood collection, before it can be shipped to a laboratory – often crossing international borders – where it undergoes the complex process of being transformed into the final CAR-T cell product. After the transformation, the finished CAR-T cell product must be transported back to one of a relatively small number of clinical environments for infusion into the patient.

This process is highly complex, requiring multiple transfers and stringent regulatory compliance at each stage. By enabling the entire manufacturing process nearer to any patient’s location, the mobile cleanrooms will allow local teams to make the therapies, with the potential to skip steps like cryopreservation and long-distance cold-chain shipping. This reduces the likelihood of delays, damage, or degradation of the cells, while empowering local medical staff all over the world.

Time: The extensive logistics involved can keep patients away from their homes and families for an unacceptably long period, further complicating their treatment journey and adding emotional and financial stress. Indeed, some patients have died on waiting lists to get the therapy, while others have been too sick to even endure the wait.

Shortening the “vein-to-vein time” – the period from when blood leaves a patient to when a therapy is given – is crucial for the effectiveness of these therapies, which have shown remarkable results in treating late-stage blood cancers and other intractable diseases. The collaboration will focus on minimizing the time from initial blood collection to the final infusion, enhancing treatment outcomes.

Germfree Contact:
Lauren Blum, Content Marketing Manager
marketing@germfree.com

Media Contacts:
IB Communications
Tel +44 (0)20 89434685
germfree@ibcomms.agency

WESTBURY, N.Y., Aug. 1, 2024 /PRNewswire/ — BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced in partnership with Germfree, a leading innovator in modular cleanroom infrastructure and services, the opening of its new cleanroom manufacturing space in Winchester, Virginia. The state-of-the-art cleanroom leverages design and solutions from Germfree to further establish BioIVT as an industry leader providing cell and gene therapy developers uncompromised access to critical GMP-compliant ancillary materials. BioIVT’s GMP-compliant cell and gene therapy supporting raw materials, including Human AB serum, will gain immediate benefits with the integration of industry leading cleanroom processes.

“This facility will play a significant role in our expanding portfolio of GMP-compliant products,” said Dr. Parijat Jain, Vice President of Cell & Gene Therapy at BioIVT. “The cleanroom was designed in collaboration with Germfree, relying on their extensive expertise to build a facility that will support client-specific manufacturing requirements and configured for high-volume production enabling product use in late-stage clinical and commercial manufacturing. We continue to evolve and strengthen our support for the development of CGT research, and our future-ready cleanroom will provide expanded capabilities and access to developers.”

The new cleanroom manufacturing space is purpose built to support excipient and ancillary material bio processing workflows. Ensuring the highest level of quality and regulatory compliance, the cleanroom boasts the following features:

• Qualified in accordance with FDA requirements
• ISO 7
• FDA-cGMP, ISO, ISE, CDC-BMBL and ASTM tested
• HVAC controls (BMS/EMS) systems
• HEPA filtration

“We at Germfree are honored to contribute to BioIVT’s groundbreaking manufacturing space by providing our modular cleanroom technology,” said Kevin Kyle, CEO at Germfree. “This new facility reflects BioIVT’s dedication to advancing biospecimen solutions and scientific research, and the company’s deep experience in helping manufacturers build cutting-edge facilities. We are excited to support their mission and look forward to the innovative achievements that will benefit the life sciences and pharmaceutical industries, fostering advancements in research and development.”

The cleanroom officially opens on Aug. 1, 2024, in Winchester, Virginia. Please visit BioIVT’s website to learn more about their work with CGT, and Germfree’s website for more on their modular CGT cleanroom capabilities.

About BioIVT

BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME-Tox products and research services, cell and gene therapy products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®. For more information, please visit www.bioivt.com or follow us on LinkedIn.

About Germfree

Germfree is a global leader in the design, manufacture, and maintenance of modular cleanroom environments. With decades of global expertise in serving the biopharmaceutical industry, Germfree specializes in providing advanced solutions that enhance the safety, efficiency, and sustainability of critical healthcare manufacturing processes. Germfree is continuing to invest in cleanroom design and manufacturing solutions and is committed to providing innovative solutions, with the goal of improving patient access to critical medicines. Germfree is backed by the healthcare growth equity investor, EW Healthcare Partners. www.germfree.com

BioIVT Contact: Charlie Chungu, Vice President of Marketing, cchungu@bioivt.com
Media Contact: Alex Connelly, PAN, 401-486-7437, BioIVT@pancomm.com

Germfree Contact:
Lauren Blum, Content Marketing Manager
marketing@germfree.com

Media Contact:
IB Communications
Tel +44 (0)20 89434685
germfree@ibcomms.agency

SOURCE BioIVT

ORMOND BEACH, Fla. and GERMANTOWN, Md., April 10, 2024 (GLOBE NEWSWIRE) — Germfree, a leading innovator in modular cleanroom infrastructure and services, and Orgenesis Inc. (Nasdaq: ORGS), a global leader in decentralizing cell and gene therapies (CGTs), today announced an asset purchase and strategic partnership aimed at advancing Orgenesis’ therapeutic programs and its suite of product development and GMP cell processing services. The collaboration’s goal is to transform the production of cell and gene therapies, making these vital treatments more affordable and accessible to patients worldwide.

By combining Germfree’s expertise in designing, manufacturing, and maintaining advanced manufacturing facility environments with Orgenesis’ cutting-edge processes and analytical development capabilities, the partnership seeks to significantly reduce the production costs of cell and gene therapy products. The ultimate goal is to enable broader adoption of life-saving treatments.

Vered Caplan, CEO of Orgenesis, stated, “Under the agreement, Orgenesis and Germfree will join forces to co-market Orgenesis’ decentralized Octomera service platform, and its Octomera Mobile Processing Units and Labs (OMPULs) globally. The partnership marks a significant milestone in the bio-manufacturing industry, as the industry begins to pivot to the paradigm-shifting distributed processing of cell and gene therapies (CGTs). Germfree will be marketing, manufacturing, and servicing OMPULs as part of its modular cleanroom fleet, enabling Orgenesis to focus on its therapeutic pipeline with an emphasis on immuno-oncology. We are delighted to work with Germfree to meet the growing demand for our platform.”

Victor Miller, CFO of Orgenesis, remarked on the financial and strategic significance of the partnership, stating, “This collaboration significantly supports Orgenesis’ infrastructure growth requirements while immediately providing a commercial footprint that will significantly impact market expansion opportunities for the partnership.”

Carol Houts, Chief Strategy Officer at Germfree, highlighted the innovative potential of the partnership, “Our collaboration with Orgenesis transcends traditional boundaries, setting a new standard for the industry. By harnessing the power of digital workflows and advanced quality management systems, we believe that we are not just streamlining production but revolutionizing it. This partnership is expected to foster innovation, particularly in how we approach and execute cell and gene therapy manufacturing. Moreover, our joint efforts with regulatory authorities worldwide are expected to ensure that our advancements not only meet, but exceed, global standards. The synergy between Germfree and Orgenesis paves the way for a future where regulatory collaboration and digital innovation ensure that life-saving therapies are developed and delivered with high efficiency and quality.”

Kevin Kyle, CEO of Germfree, shared his insights on the collaboration, “Our strategic partnership with Orgenesis is a cornerstone in the continuation of our mission to advance healthcare solutions globally. By integrating Germfree’s modular cleanroom technology with Orgenesis’ innovative cell and gene therapy programs, we are setting a new benchmark for efficiency and accessibility in the treatment of life-threatening conditions. This collaboration is not just about enhancing production capabilities; it’s about creating a paradigm shift in how cell therapies are developed, produced, and delivered to those in dire need. Together, we are building the foundation for a future where advanced medical treatments are no longer a privilege, but a right, accessible to everyone, everywhere.”

For more information about Germfree and Orgenesis and their strategic partnership, please visit www.germfree.com and www.orgenesis.com.

About Germfree

Germfree is a global leader in the design, manufacture, and maintenance of modular cleanroom environments. With decades of global expertise in serving the biopharmaceutical industry, Germfree specializes in providing advanced solutions that enhance the safety, efficiency, and sustainability of critical healthcare manufacturing processes.   Germfree is continuing to invest in cleanroom design and manufacturing solutions and is committed to providing innovative solutions, with the goal of improving patient access to critical medicines. Germfree is backed by the healthcare growth equity investor, EW Healthcare Partners. www.germfree.com

About Orgenesis

Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger number of patients more cost effectively and with better outcomes through great science and decentralized production.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our decentralized cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our decentralized cell therapy processing, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us, our ability to remain listed on Nasdaq and the risks and uncertainties discussed under the heading “RISK FACTORS” in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Investor relations contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: orgs@crescendo-ir.com

Communications contact for Orgenesis:
IB Communications
Michelle Boxall

Media Contact for Germfree:
Lauren Blum, Content Marketing Manager at Germfree
+1 386-265-4300
Marketing@germfree.com

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

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.

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 Title21Health 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. 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: 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. www.title21.com

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.

“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.

Media Contact
Lauren Miller, Content Marketing Manager,
Germfree Laboratories,
1 386-265-4300,
Marketing@germfree.com,
www.germfree.com

Ron Reha, Senior Manager, Strategy and Innovation,
Title21 Health Solutions,
1 928-220-3045,
ronaldr@title21.com,
www.title21.com

Germfree is passionate about growing our workforce and developing talent. Florida Federation for Advanced Manufacturing Education (FL FAME) provides an opportunity to pursue an arduous career in advanced manufacturing or technology in various sectors, while simultaneously receiving the necessary education to enhance your resume and become highly sought-after by employers throughout Florida. Tanner Thacker was in the very first cohort of the Florida FAME chapter. This group graduates on May 12th 2023 and Germfree is thrilled that Tanner has chosen to remain at Germfree in his new role as CQV Technician. Congratulations!

Take an immersive 360 degree tour of one of the most innovative cGMP/BSL-3 modular laboratories on the market built by Germfree. This facility boasts two of Germfree’s custom class 3 biosafety cabinets integrated with Germfree active HEPA purging material pass throughs. This is the most innovative facility of its kind ready for a complex cGMP manufacturing process requiring BSL-3 level containment.