Building Germfree in Europe and the UK

Offsite-built cleanroom solutions

Creating environments that serve life science innovation & global health

G E R M F R E E ABOUT US

EXPERT ENVIRONMENTS

Global leader in biosafety and aseptic processes In 2019 Ardmac and Germfree announced their partnership to bring Germfree bioGO® Mobile and Modular Cleanroom Buildings to the European markets. Germfree is an innovator across industries that harnesses decades of experience to deliver cutting edge solutions for the next generation of pharmacy, biocontainment and biopharma cleanroom technologies. Germfree solutions always deliver.

Serving life sciences innovation and global health It is the dedication of Germfree and Ardmac that enables rapid deployment of critical infrastructure both to modern research facilities and the front lines of global health security. Germfree delivers expert environments for specific applications built-offsite.

Offsite-Built Cleanroom Solutions Germfree designs and manufactures complete BioPharma mobile and modular facilities to provide fast and flexible cGMP-compliant production space. Our bioGO units incorporate cleanroom process areas as well as containment space.

They are all self-contained and suitable for installation into an existing building or as a freestanding facility.

Leader in GMP and Biocontainment Solutions 50+ yrs Serving Life Sciences and Global Manufacturing Base

Our modules are uniquely stackable and suitable for internal and external use.

Germfree and Ardmac have partnered to bring Germfree bioGO, mobile and modular cleanroom buildings to the European markets. The Germfree bioGO cleanroom solution adapts to your business needs by optimising your company’s time-to-market and return on investment.

Trusted Operational Readiness Partner

Internationally accredited construction company 40+ yrs experience in delivering high value workspaces and technical environments

Leader in Quality Risk Management

SCALABLE

STACKABLE

INTERNAL EXTERNAL

READILY AVAILABLE

Global Service Presence

EXPERT ENVIRONMENTS

MOB I L E Rapid deployment, self contained, GMP compliant Cleanroom trailers. Each mobile facility is engineered and constructed to meet or exceed the CDC NIH BMBL guidelines for BSL-2 laboratories and the World Health Organization (WHO) guidelines for BSL-3 laboratories.

Dedicated stand-alone, ceiling fitted HVAC system and infrastructure in all options

SOLUTIONS OVERVIEW

Rapidly deployable, scalable GMP manufacturing and laboratory facilities...

AVAILABLE IMMEDIATELY WITH RENTAL OPTIONS (depending on availability)

70+ deployments globally

to the world’s leading pharma and biotech companies, contract and manufacturing organisations (CDMOs) and biotech start ups. needs by optimising your company’s time-to-market and return on investment

Fully autonomous single module GMP Cleanroom facility.

S I NGL E MODUL E Modular facilities are engineered and

1. Mobile 2. Modular 3. Multi-Module

constructed to meet or exceed the quality of brick and mortar construction while reducing risk and accelerating time to market.

OPERATIONALLY READY WITHIN 6 MONTHS

Standalone and self-supportive suitable for installation in existing facilities.

Multistorey modules suitable for internal and external use.

MULTI -MODULE FACILITIES Interconnecting, multistorey units providing flexability and scalabilty for all of your immediate and future requirements. Select from a number of application ready standard layouts or chose a more customised option

Expand only when ready

Rapidly deployable

Adaptable and Flexible

SCALABLE

SPEED

FLEXIBLE

PRE-CLINICAL

CLINICAL

COMMERCIAL

Facilities that suit all stages of drug development – our facilities grow with you – only invest in the space you need as your process evolves and the scale of your commercial opportunity becomes clearer .

OPERATIONALLY READY WITHIN 10 MONTHS

EXPERT ENVIRONMENTS

SOLUTIONS OVERVIEW

Facilitating the cures of tomorrow – One bioGO ® Cleanroom Building at a time Germfree starts with big ideas centered on the needs of innovators. Access to facilities, materials and expertise are constraints facing the advanced therapy industry. The bioGO® cleanroom building removes barriers by fast-tracking tangible solutions that can be scaled.

G E R M F R E E MODULAR SOLUTIONS

Increasingly, we’re seeing our clients look towards our mobile and modular offering, reflecting the significant benefits of this form of construction:

FLEXIBILITY: Reconfigurable templates facilitate the ever-evolving ATMP space

S P E ED : Significant time savings vs. traditional

OPTIMISE CAPITAL INVESTMENT: Scale your facility as your product development progresses through clinical into commercialisation and accommodate multiproduct pipelines. Rental options on our mobile GMP suites are available.

GEOGRAPHIC EXPANSION: With operations in the UK, Europe and USA, we support our clients’ global manufacturing requirements with smart, standardised, flexible, scalable cleanrooms that can be delivered at speed

EXPERT ENVIRONMENTS

Scan QR code to view our time-lapse production video demonstrating rapid modular fabrication.

HOW WE WORK

Delivering operational readiness faster

Traditional Delivery Model : Sequential and Disjointed

OPERATIONS

CONSTRUCTION

COMMISSIONING

QUALIFICATION

ENGINEERING

TIME TO MARKET

GermFree / ARDMAC / CAI delivery model : Parallel and Integrated

DESIGN

CONSTRUCTION

OPERA TIONS

TIME TO MARKET

REDUCED TIME TO MARKET

EXPERT ENVIRONMENTS

CASE STUDY Modular mRNA Manufacturing Facility in Africa

Germfree were contracted to deliver two modularised vaccine manufacturing suites for a multinational pharmaceutical client. The first project, situated in Germany, was completed in two phases as a proof of concept, achieving a Percentage Manufactured Value of 78% of works completed offsite. A second project was then commissioned with Germfree to deliver suites into central Africa, with the PMV achieving 98% of works completed offsite, including full factory acceptance testing and commissioning. During development of project two, our design time decreased by 50% as the scheme was proven as a flexible and scalable solution through the adaption of a standardised and repeatable design. As we developed the project together with our client team, improvements were tabled and implemented allowing the total time spent on site with the installation of the modules to reduce from 12 weeks on Phase One to 4 weeks on Phase Two. This joint learning and development supported our client to honour their commitment to deliver facilities to an African state in 2022; a historic event for the continent and humanity as we responded to the global pandemic of Covid-19.

The Germfree Modular Cleanrooms are fully self-contained pharmaceutical facilities which are scalable to suit clients’ needs, transportable globally due to their standard 40-foot container size and customisable to our clients processes and requirements. To date, Germfree have delivered multiple modular cleanrooms to clients within Ireland, Mainland Europe, and to the continent of Africa. To demonstrate our versatility, we chartered the Antonov AN124, one of the largest cargo planes currently available globally, to transport the first of the modular units into Rwanda. The significance of this delivery was a major political event for the African Union highlighting the speed at which these modular facilities can be deployed globally, using various means of transport to achieve the required goals, to regions that would not be traditionally considered for pharmaceutical facilities. The launch of the Modular Cleanrooms bound for Africa by our client was attended by senior leaders of WHO (World Health Organization) as well as several Presidents and Prime Ministers from the African Union, European Union and other global dignitaries, all of which received significant media coverage.

Other project details: Multi Module 40Ft Containments

EXPERT ENVIRONMENTS

CASE STUDY Modular Biopharmaceutical Cleanroom/Production Facility

CASE STUDY Modular Cell and Gene Therapy ISO 7 Cleanroom Facility

A large National Public Health Organization had an urgent need for a new Tumor Infiltrating Lymphocytes (TIL) production facility to serve the organization’s surgery branch. This facility is for the relocation of the manufacturing programme, which complies with the latest FDA-GMP requirements and regulations. Germfree’s bioGO® Modular Solution involves approximately 558m² (Gross) of manufacturing suites, lab, office, QA/QC, storage, and supporting area, all constructed within ten (10) Factory Acceptance Tested (FAT) modules. Modules are completely built offsite, tested, then delivered and installed. The “Turnkey” system from Germfree includes necessary mechanical and electrical equipment, including AHU/s and chillers to support operations.

The scope included a large mezzanine space which made the facility self-sustaining and turnkey. The facility connected to campus utilities.

Germfree was tasked to design and build a bioGO® Modular Cell/Gene Therapy Facility to serve a National Public Health Organization for the manufacture of Phase I & II clinical materials, supporting the development of autologous and allogeneic cell therapies. Due to the presence of Phase II clinical materials, the completed modular facility complies with current Good Manufacturing Practices (cGMP) as they apply to the assessed risks of cell therapy. The Germfree bioGO® Modular Solution measures approximately 325m² (Gross) and will be installed on the roof of an existing hospital building. The new FDA-GMP facility includes manufacturing suites, an administrative area, storage, and a supporting area. The modular solution will also include required mechanical and electrical equipment including AHU/s and chillers, as well as access to the facility. The new manufacturing program operated in this facility will comply closely with the latest

FDA requirements and regulations. Within the modules are four (4) fully independent ISO- 7 cleanroom labs, built with dedicated entry and exit anterooms to mitigate vector cross-contamination. The concept also provides cryogenic containment for finished products, clean supply storage, administrative and support areas plus other areas and features required for a fully functional, unidirectional flow facility. Additionally, this facility is ‘temporary’ and can be dismantled and moved to another location with minimal demolition.

Other project details: 10 prefabricated modules, Bidirectional layout, Single pass air, Segregation, >604m² mezzanine space.

A mezzanine housing the Mechanical Plant was included in the scheme. The facility was installed on a 3rd floor terrace.

Other project details: 6 prefabricated modules, Unidirectional layout, Single pass air, egregation, 325m² mezzanine space.

EXPERT ENVIRONMENTS

Your European & UK Team Get in touch directly

At Ardmac your enquiry will be dealt with promptly by our highly experienced Team

Michael Quinn MD Offsite Manufacturing & Engineering Swords Business Campus Swords, Co. Dublin K67 D8H0 Ireland

For US and International Inquiries: Germfree Laboratories, Inc. 4 Sunshine Blvd Ormond Beach, FL 32174 USA

michael.quinn@ardmac.com +353 (0) 87 745 0505

+1 (386) 265-4360

EXPERT ENVIRONMENTS

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