bioGO BSL-3 Mobile Biocontainment Laboratory

Germfree’s bioGO Mobile Biocontainment Laboratories offer the ideal solution for providing surge capacity for laboratory services during periods of emergency, like the current global pandemic. By utilizing a fully equipped, turnkey, Mobile Biocontainment Laboratory, facilities are able to rapidly increase their volume without sacrificing capabilities

bioGO BSL 2 & 2+ Mobile Biocontainment Laboratories

Germfree’s bioGO® BSL 2 and BSL 2+ Mobile Biocontainment Laboratories offer the ideal solution for providing surge capacity for laboratory, pharmacy, and research use. Utilizing a fully equipped, turnkey, Mobile Biocontainment Laboratory during periods of high demand or crisis allow various facilities to rapidly increase volume without sacrificing capabilities. Each mobile laboratory is engineered and constructed to meet or exceed the CDC NIH BMBL guidelines for BSL-2 and 2+ laboratories.

bioGO 40’ ISO Container BSL-3 Laboratory Building

Germfree’s bioGO Laboratory Buildings offer a new approach to rapidly bringing high-quality and cost effective laboratory capacity to any region of the world, especially during times of crisis. These offsite built, containment ready facilities meet the World Health Organization (WHO) guidelines for BSL-3 laboratories. Germfree’s precision laboratories contain spacious interiors engineered to provide an ergonomic and effective work environment. By utilizing an ISO container platform, this fully equipped Biocontainment Laboratory can be deployed globally at any scale. These turnkey units are precommissioned and tested to ensure compliance upon delivery to site. Germfree facilitates all aspects of the project — delivered, installed and made operational in a truncated timeline.

Class III Biosafety Cabinets

Germfree is a leader in Class III Biosafety Cabinets (BSC) designed a variety of pertinent research and development applications. With decades of experience, Germfree specializes in the seamless integration of analytical instruments and process equipment. Germfree Class III BSCs are engineered with the optimal direct connections to any laboratory equipment, including autoclaves, incubators, and gas decon systems. Germfree BSC’s are designed with the user in mind where analytical equipment controls can be placed outside of the containment zone.

University campuses, corporate campuses, business parks, and manufacturing facilities are provided full-time, high throughput testing capabilities via a space-efficient and convertible laboratory. These facilities, along with local governments, enable an expanding testing network to monitor disease transmission and protect communities nationwide.

Protecting Communities, Advancing Global Health
Enabling Scaled Local Testing

At a Germfree/HOK bioGO facility, it is estimated an average of 240 samples per day can be self-collected by the participants. With additional guidance from telemedicine, a test-kit is provided to participants who are assisted by limited personnel in PPE. These facilities limit the need for large quantities of individuals in PPE to collect samples on the ‘frontline’ which will soon become the institutions that scores of individuals will be returning to work or learn. Up to 80 batches can be processed at a time in under 60 minutes with high-throughput testing platforms such as Cepheid GeneCpert Express, which will be available lab options.

Process and registration information is provided on the website on outside the mobile lab. A healthcare worker will scan a QR code sent to each participant’s mobile device and provide further instruction. Following the provided procedures, each person will collect their own sample and test results will be released within 24 hours.

Return to Work, Done Right

The Germfree/HOK COVID-19 Testing Labs will offer a clear and controlled method for a ‘safer’ return to work. As companies and educational institutions attempt to come together again, rapid testing is the only way to ensure a return of infection is mitigated.

This guidance for environmental specimens is intended for only those laboratories that perform virus concentration procedures, including wastewater/sewage surveillance testing, and not for public health or clinical diagnostic laboratories that handle COVID-19 clinical specimens or laboratories that perform culture and isolation of SARS-CoV-2. Site and activity-specific biosafety risk assessments should be performed to determine if additional biosafety precautions are warranted based on situational needs, such as high testing volumes or large volumes, and the likelihood to generate infectious droplets and aerosols. Procedures that concentrate viruses, such as precipitation or membrane filtration, can be performed in a BSL-2 laboratory with unidirectional airflow and BSL-3 precautions, including respiratory protection and a designated area for donning and doffing PPE. The donning and doffing space should not be in the workspace. Work should be performed in a certified Class II BSC. Read More.

Germfree’s BSL-2+ Mobile Biocontainment Laboratory has
been designed to meet or exceed these parameters:

• BSL-2 – The Mobile lab complies with the NIH CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th edition guidelines for BSL-2.
• Unidirectional Airflow – In addition to meeting BSL-2+ requirements, the mobile lab includes a variable Capacity, 11 Ton HVAC system designed to maintain a unidirectional, ISO–7 cleanroom environment (Class 10,000 cleanroom).
• BSL-3 Precautions
  • HEPA filtered supply air and HEPA filtered exhaust air
  • Anterooms
  • Directional airflow
• Designated Areas for Donning and doffing PPE – There are two dedicated anterooms onboard for donning and doffing PPE.
  • The donning and doffing space should not be in the workspace – They are not.
• Work should be performed in a certified Class II BSC – The Mobile lab is equipped with two (2) Class II, Type A2 Biological Safety Cabinets to protect the product and personnel. One of the Class II Type A2 Biological Safety Cabinets is exhausted to the exterior through a HEPA Filter to capture potentially infectious aerosols.

Germfree’s mobile and modular compounding pharmacies deliver rapid time to market and turnkey functionality, which is critical in periods of pharmacy renovations, upgrades, or unexpected closures.

The article outlined a series of questions to ask when considering a mobile cleanroom, the second which was answered by Germfree’s Jeff Serle:

“2. Buy or Lease? Most hospital pharmacies—including Yale New Haven Health and Dayton VA Medical Center—have chosen to lease their mobile cleanrooms, but if one or more are needed for an extended period, buying may be more economical. “Larger hospital chains that are planning to go through renovations at multiple locations may elect to purchase,” said Jeff Serle, the senior vice president of engineering for Germfree. “They are very mobile and can be fully repositioned in two to three weeks, including certification for use. Then they can be safely shut down and stored for periods of time, and you have an asset afterward in situations like disaster recovery.” – Excerpt from Pharmacy Practice News (PPN).

To learn more about Germfree’s Pharmacy solutions, click here.

New York and Ormond Beach, FL – EW Healthcare Partners announced today that it has acquired Germfree Laboratories, Inc., a leading U.S. manufacturer of turnkey, mobile and modular cleanrooms and biocontainment facilities, as well as the equipment and services required for critical environments.

Founded in 1962, Germfree has continuously provided advanced solutions for healthcare and life science clients. The company has experienced significant growth over the years, with more than 200 facilities deployed on six continents and nearly 200 employees located in its  173,000 ft2 (16,000 m2), environmentally controlled, manufacturing plant in Ormond Beach, Florida. Germfree’s mobile and modular solutions are well-suited to service major, highly-regulated market segments in Biopharma, Compounding Pharmacy, and Biocontainment.

“There is an increasing demand for mobile and modular cleanrooms in biopharma to keep pace with new technologies and platforms, capacity constraints and the demand for flexible solutions that are delivered quickly,” said Evis Hursever, Managing Director at EW Healthcare Partners. “Germfree is addressing this demand for cleanrooms by designing and manufacturing advanced solutions for specialised and flexible cGMP-compliant manufacturing space. We look forward to working with Kevin and his team to further accelerate the company’s growth into the fast-growing ATMP (advanced therapy medicinal products) sector.”

“Together with EW, Germfree is positioned to maximize and scale our manufacturing to help fill the biomanufacturing capacity gap facing biopharma,” said Kevin Kyle, Germfree’s CEO. “EW is the perfect partner to foster and fuel Germfree’s growth journey. Our shared mission to deliver innovation in healthcare and biopharma, and their commitment to our next stages of growth and long-term success, makes this a tremendous strategic fit. Further, EW’s expertise and experience in advanced therapeutics and their extensive global network add synergy, as we expand our solutions to meet the fast-growing demands in segments such as cell and gene therapy.”

Kirkland & Ellis acted as legal adviser, A&M as FDD and tax adviser, and BCG as commercial due diligence adviser for EW Healthcare Partners.  Jefferies LLC served as exclusive financial advisor and Holland & Knight LLP acted as legal adviser to Germfree.

About EW Healthcare Partners (“EW”)

With over $4 billion raised since inception, EW Healthcare Partners is one of the largest and oldest 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 Germfree Laboratories, Inc.

For six decades, Germfree has been creating environments that serve life science innovation and advance global health. The company designs and manufactures mobile and modular cleanrooms and high-containment laboratories, as well as a comprehensive line of biosafety and aseptic processing equipment. Germfree’s bioGO® cleanrooms provide flexible, scalable solutions for biopharma and advanced therapy manufacturing. With over 200 facility installations in 32 countries, Germfree is a global company, committed to enabling its clients to develop new life-saving cures or prevent the next pandemic. The Germfree team provides leading-edge engineering and technology, subject-matter expertise, and a foundation of highly skilled builders, all located at its facility in Ormond Beach, Florida. https://www.germfree.com/.

Media Contacts:
Taylor Miller
tmiller@germfree.com
(386) 265 – 4300

Anne DeMaret
ademaret@ewhealthcare.com
(281) 528 – 1956

Germfree’s biomanufacturing platform addresses current industry needs, while de-risking and future-proofing for a rapidly evolving industry. “The industry is delivering on the promise of cell and gene therapeutics with rapid development and growth. New patient care requirements are a key consideration, adding a sense of urgency. The precise timing and logistics of collecting a patients cells may not work in a centralized model. Our mobile platform supports decentralized models, which will also allow the industry to democratize these therapies globally” said Carol Houts, VP of Business Development.

“The bioGO mobile platform supports the scale-out process by using standard, proven cGMP facility designs that are pre-commissioned and pre-qualified, significantly shortening the time to process readiness. Process spaces can also be reconfigured or interconnected to add bioGO units, for a larger facility. We are delivering fast, flexible and cost-effective infrastructure, previously not available,” said Kevin Kyle, CEO of Germfree.

The extremely high cost of clinical trials, was also a consideration when rolling out bioGO. The adaptive infrastructure and financial model can promote development by reducing early financial obstacles. Fast, flexible space allows clinical trials to start when needed. A trial can become operational, pivot or scale without traditional capital building expenditures.

“We looked at the main drivers that are important to our clients and patients. Germfree’s bioGO Mobile Cleanrooms will be an impactful solution in overcoming many of the challenges the industry is facing,” said Kevin Kyle.