From his early days as an interior contractor to pioneering architectural finishes for high-containment environments, Ghislain’s story is one of vision and grit. What began with a simple request from IBM for a low-maintenance wall system evolved into a revolutionary idea—transforming industrial-grade polymers into architectural solutions.

That spark led to the birth of Arcoplast.

Despite early skepticism and industry challenges, Ghislain saw potential where others didn’t. He focused on sectors where performance mattered most—dairy, food production, and high-containment environments—and built a company that didn’t just meet expectations but redefined them.

“I’m proud that we’ve built something truly unique; products others don’t dare attempt,” Ghislain shared. “We shine because we’re so far ahead of the curve.” The acquisition by Germfree in 2024 was a milestone that validated Arcoplast’s mission and values. “It wasn’t just any acquisition. It was by a client that I deeply respect. We made each other better over many years,” he reflected. As he steps away, Ghislain leaves Arcoplast in the capable hands of Steve Sebastian, a leader he describes as humble, brilliant, and deeply respected. “What took me a lifetime to learn, he’s mastered in five years,” Ghislain said. “I couldn’t ask for a better person to lead the next chapter.”

“Ghislain’s impact on Arcoplast and the industry is immeasurable. His ability to see opportunity where others saw limitation has shaped not only Arcoplast but also Germfree and the standards of our field. I’m honored to carry forward his legacy and excited to work alongside the next generation of talent at both Germfree and Arcoplast. The future is bright, the combination of our teams is unstoppable, and we’re just getting started. Please join us in celebrating Ghislain’s extraordinary career and the exciting road ahead for Arcoplast!” stated Kevin Kyle, CEO of Germfree.

To our customers, partners, and team: Arcoplast’s mission remains unchanged. The foundation is strong, the leadership is solid, and the future is bright. Ghislain’s legacy will continue to inspire us as we build on his vision—creating environments that stand the test of time.

Boston, MA, June 17, 2025 – At the BIO International Convention 2025 in Boston, King Faisal Specialist Hospital & Research Centre (KFSHRC) and Germfree Laboratories, LLC announced a strategic partnership to develop Saudi Arabia’s first fully integrated, modular Advanced Therapy Medicinal Product (ATMP) Manufacturing Campus.

The new facility will be located at KFSHRC’s main campus in Riyadh and will serve as a critical milestone in advancing Vision 2030 and the National Biotechnology Strategy, two national initiatives aimed at transforming the Kingdom into a global hub for life sciences, biomanufacturing, and to become a global biotech hub by 2040.

“This initiative marks a historic milestone, not just for our institution, but for the Kingdom of Saudi Arabia in alignment with Vision 2030 and the National Biotechnology Strategy,” said His Excellency Dr. Majid bin Ibrahim Al Fayyadh, CEO of KFSHRC. “With Germfree as our partner, we are creating a world-class advanced therapies campus that will accelerate access to transformative treatments, draw the brightest minds in science, and strengthen Saudi Arabia’s position as a global leader in biotechnology. This fast-track, strategic project represents a continuation of the long history of healthcare innovation that has been realized by King Faisal Specialist Hospital and Research Centre.”

“KFSHRC’s leadership and vision align with Germfree’s mission to expand access to complex therapies through future-proofed, agile infrastructure,” said Kevin Kyle, CEO of Germfree Laboratories. “Together, we are building much more than a facility for Cell & Gene Therapy manufacturing, we’re building a turnkey, scalable platform for discovery and delivery of curative therapies for the people of Saudi Arabia, the Middle East, and beyond. This collaboration reflects the critical role infrastructure plays in unlocking access to advanced therapies, and we are proud to support KFSHRC’s vision for patient-centric care.”

Under the terms of a signed Letter of Intent, the turnkey project will fast-track the Kingdom’s ability to manufacture cell and gene therapies locally, host international clinical trials, and attract leading pharmaceutical partnerships and scientific talent from around the world.

This project directly supports Saudi Arabia’s National Biotechnology Strategy, launched to localize vaccine and therapeutic production, develop sovereign biomanufacturing capabilities, and establish the Kingdom as a global biotechnology leader by 2040.

As a core pillar of Vision 2030, the strategy aims to make Saudi Arabia a destination for clinical trials, scientific discovery, pharmaceutical investment, and biotech entrepreneurship across the Middle East and beyond.

By establishing a globally competitive manufacturing campus, KFSHRC is not only advancing national healthcare; it is setting a new global standard for innovation, scalability, and patient-centered care.

King Faisal Specialist Hospital & Research Centre is Saudi Arabia’s foremost tertiary-and-quaternary referral institution, delivering world-class care in oncology, transplantation, cardiovascular medicine and precision therapeutics. It is ranked No. 1 in the Middle East & Africa and 15th globally among academic medical centers by Brand Finance’s 2025 report and is listed on Newsweek’s World’s Best Hospitals as well as World’s Best Smart Hospitals 2025. As a flagship partner in the Kingdom’s Vision 2030 and National Biotechnology Strategy an initiative to localize biomanufacturing and make Saudi Arabia a global biotech hub by 2040, KFSHRC forges international collaborations, drives cutting-edge clinical research, and cultivates Saudi scientific talent to expand patient access to life-changing therapies.

Ormond Beach, FL, Nov. 12, 2024 – Germfree Laboratories, On Demand Pharmaceuticals (ODP), and North Mississippi Medical Center-Tupelo (NMMC) have teamed up to address the global drug shortage crisis with a groundbreaking point-of-care medicine production solution. The expanding partnership aims to bring agile production of essential medicines closer to the point of care across the country and globally, ensuring a reliable supply of life-saving drugs.

With more than 75% of U.S. hospitals facing medication shortages and millions of people in low- and middle-income countries lacking access to critical medicines, the need for localized, flexible production is urgent. By combining Germfree’s mobile cleanroom technology with ODP’s Pharmacy on Demand platform, this collaboration empowers healthcare providers to produce high-quality medications on site, reducing reliance on fragile global supply chains.

The partnership builds on a six-month pilot study that leveraged ODP’s platform technology and Germfree’s mobile cleanroom capability to produce syringes of common shortage medicines at NMMC, including lidocaine, rocuronium, and potassium chloride. This real-world pilot met all regulatory requirements, leveraged a state-of-the art quality management approach, and demonstrated a novel, agile compounding capability for drugs on shortage. It resulted in patients being treated with high-quality medicines that were made on-demand and on-site.

“We’re not just filling gaps in the supply chain, we’re redefining it,” said Kevin Kyle, CEO of Germfree. “With On Demand Pharma, we are enabling healthcare providers to meet patient needs faster and more reliably, whether in urban centers or rural areas. This partnership also demonstrates our commitment to using cutting-edge technologies to improve the way hospital pharmacies respond to the needs of their patients, with more to come.”

Matt Pietras, CEO of On Demand Pharmaceuticals, added, “This collaboration with Germfree provides us with the high-quality modular infrastructure needed to provide our Medication-as-a-Service (MaaS) where patients and healthcare providers need it most.”

The innovative model will allow hospitals like NMMC to produce critical medications locally, improving access for patients and ensuring continuity of care even during global supply disruptions. “Our pilot work completed through this collaboration has proven these new capabilities for on-site compounded medications are able to help us better serve our communities in a timelier manner,” said Wes Pitts, System Director of Pharmacy at North Mississippi Health Services, which includes NMMC in Tupelo. “In our pilot program, we were able to successfully compound approximately 12,000 doses of shortage medications starting in December 2023 following regulations from the Board of Pharmacy.”

“We are on the cusp of expanding distributed medicine production through our network while creating a new paradigm,” said John Lewin, Chief Medical Officer at ODP. “I envision a future where pharmacists take a leading role in medicine production – both today and as personalized medicine becomes the standard at the point of care.”

The collaboration between Germfree and On Demand Pharmaceuticals is set to transform the future of medicine accessibility by providing healthcare providers with the tools to produce medications on demand, whenever and wherever they are needed.

About Germfree Laboratories: Germfree Laboratories is a global leader in cleanroom and critical environment technologies, specializing in providing innovative solutions for biopharmaceutical, healthcare, and research sectors. Learn more at www.germfree.com.

About On Demand Pharmaceuticals: On Demand Pharmaceuticals (ODP) is revolutionizing pharmaceutical access with its Pharmacy on Demand platform, offering agile, on-site production of medications. ODP is committed to overcoming industry barriers and ensuring high-quality medicines are accessible to all. Learn more at www.ondemandpharma.com.

About North Mississippi Medical Center: North Mississippi Medical Center (NMMC) is one of the largest non-metropolitan hospitals in the U.S., providing comprehensive medical services to a growing community. NMMC is committed to innovation in healthcare delivery to ensure high-quality, accessible care for its patients. For more information, visit www.nmhs.net.

SOURCE Germfree Laboratories LLC

Media Contacts:
Germfree Laboratories:
Lauren Blum, Content Marketing Manager
marketing@germfree.com

On Demand Pharmaceuticals:
Media Relations
media@ondemandpharma.com

North Mississippi Medical Center:
Deborah Pugh
drpugh@nmhs.net

ORMOND BEACH, Fla., Oct. 14, 2024 /PRNewswire/ — Germfree, a pioneering leader in modular and mobile cleanroom infrastructure, equipment and services, today announced the acquisition of Arcoplast, maker of the leading seamless primary barrier cleanroom wall and ceiling system for Life Science applications and more. The acquisition will allow Germfree to offer comprehensive facility solutions from the ground up and follows 17 years of collaboration between the companies, during which Arcoplast has supplied architectural systems for Germfree installations at over 200 facilities globally.

Arcoplast primary barrier systems form the basis of design for BSL-3, ABSL-3, BSL-4, high-tech laboratories, and cleanrooms from NIH to CDC to NASA, throughout academia and in industries ranging from cell and gene therapy to food and beverage. Architects, engineers, and lab planners depend on the safety, durability, and long life cycle of Arcoplast’s wall and ceiling systems. The Arcoplast system is differentiated from others through their numerous certifications around environmental sustainability while also being by far the most durable architectural finish available to Life Science clients, eliminating the need for maintenance. As well, the non-porous, ultra-smooth surface finishes, seamless panels, and high-performance Bio-Seal systems combine to enable best-in-class cleaning, disinfecting, and bio-decontamination that is backed up by science and testing.

“Coming together with Arcoplast is critical for the next phase of Germfree’s growth, as we expand beyond mobile and modular spaces to fixed-facility and hybrid, turnkey facility solutions. I welcome the Arcoplast team to the Germfree family,” said Kevin Kyle, CEO of Germfree. “We’ve known and worked with these incredible people for many years and will now further leverage our combined experience to offer stick-built construction of cleanrooms, biocontainment facilities and more with Arcoplast’s unique interior finishes that are the most durable, most sustainable, and most tested system available. The combination of Germfree’s facility and equipment expertise with Arcoplast’s architectural finishes is one way that we will continue to unlock the scientific potential of our global client base.”

“As one of the largest users of our architectural systems, Germfree has long understood the importance of using the highest-quality materials for its builds in support of its projects across both the developed and undeveloped world,” said Ghislain Beauregard, President of Arcoplast. “Our company cultures are perfectly aligned around client service and innovation. This acquisition reflects a shared commitment to our pursuit of greener and more robust laboratories, hospital pharmacies, and cGMP facilities thanks to years of R&D and testing that have gone into Arcoplast composite materials. Together, we look forward to showing the market a better solution with improved constructability and lower environmental impact, with no rejuvenating maintenance program requirements for the facilities of the future.”

A seamless, end-to-end service that includes both infrastructure and highly specialized containment systems is key to streamlining construction processes and reducing project timelines.

To see the revolutionary Arcoplast system in person, visit Germfree’s booth #1529 this week at the 2024 International Society for Pharmaceutical Engineering (ISPE) Annual Meeting & Expo in Orlando, Florida.

About Germfree
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.  Learn more about partnering with Germfree at www.germfree.com.

About Arcoplast
Arcoplast has an international reputation as an industry leader in the field of high containment and controlled environments. Arcoplast earned its reputation by meeting compliancy standards all around the world, passing numerous laboratory tests, and enduring over 30 years real time scientific and industrial workloads.

SOURCE Germfree Laboratories LLC

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

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

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

Ormond Beach, Florida – Germfree announces the appointments of Dorothy Puhy, Karen Flynn, Kerry Ingalls and Helga Salling as independent non-executive members of its Board of Directors.

“We are excited to welcome Dorothy, Karen, Kerry and Helga to our Board of Directors.  Their counsel will guide strategic alternatives, aid Germfree in capitalizing on opportunities, and navigate future challenges. Leveraging their collective expertise, the Board will play a pivotal role in driving sustainable growth and ensuring long-term success. Germfree’s story is one of relentless innovation, unwavering commitment to quality, and profound impact on global health. We remain committed to advancing innovation and maintaining our position as a leader in critical environment equipment, cleanrooms, and laboratories. Our Board will help Germfree to capitalize on emerging trends and technological advancements, particularly in the rapidly evolving fields of cell and gene therapy,” said Kevin Kyle, CEO at Germfree.

Dorothy Puhy brings considerable experience to the Germfree Board and is well recognized for her financial expertise. She dedicated 25 years to the Dana Farber Cancer Institute, culminating in her role as Executive Vice President and Chief Operating Officer. Prior to that, she was Chief Financial Officer and held various financial positions at the Tufts – New England Medical Center Hospitals. Dorothy served as a Lead Director at Abiomed for c. 20 years, until the successful acquisition of the company by JNJ. As a Lead Director of Abiomed, Dorothy worked closely with the management team and other Board members to set strategic goals and overall direction. In addition to Abiomed, Dorothy served on the boards of BCBS, Azenta and Reebok. She was on the adjunct faculty at Harvard School of Public Health for many years.

Karen Flynn brings more than three decades of commercial and operations experience to the board of Germfree. Most recently, she served as Interim President of BioModalities at Catalent. Preceding this role, Karen held positions as Chief Commercial Officer and President of Biologics at Catalent. Prior to her tenure at Catalent, she served as Senior Vice President and Chief Commercial Officer for West Pharmaceutical Services, also assuming the role of President of its Pharmaceutical Packaging Systems business. Besides her involvement with Germfree’s board, Karen currently holds positions on the Boards of Quanterix Corporation and Sotera Health.

Kerry Ingalls is a pharma veteran who brings experience across manufacturing and operations. He previously served as Chief Operating Officer of Poseida Therapeutics, overseeing corporate strategic planning, operations, and the construction, commissioning, and licensing of the CGT manufacturing plant. Prior to his time at Poseida, Kerry held various leadership positions at Amgen for many years, managing multiple operations sites and overseeing all clinical and commercial GMP manufacturing at Amgen’s global headquarters. Before joining Amgen, Kerry had a distinguished career in the US Navy.

Helga Salling presently holds the position of Vice President, Global Growth & Strategy- Life Sciences at Jacobs. With over twenty years of experience in the Life Sciences sector, Helga brings valuable expertise to the Germfree Board. Before joining Jacobs, Helga served as VP Integrated Projects at IPS, and before that, she held positions at DPS Group and served as COO at Advent Engineering.

“We are excited to welcome Dorothy, Karen, Kerry and Helga to our Board of Directors.  They bring decades of experience, leadership and strategic thinking in key markets that Germfree serves. We are thrilled to be working with them as we aggressively scale the business to meet the needs of our customers, in particular in the cell and gene therapy space,” said Evis Hursever, Managing Director at EW Healthcare Partners and Chair of the Board of Directors.

About Germfree

Germfree 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.

About EW Healthcare Partners

With over $2 billion of capital raised since 2014, EW Healthcare Partners 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.  EW Healthcare Partners has a singular commitment to the healthcare industry and has been a long-term investor in numerous healthcare companies, ranging across sectors, stages and geographies. The team of senior investment professionals, operating partners and advisors is based in New York, London and Houston.  https://www.ewhealthcare.com/

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