Building Germfree in Europe and the UK

Building Germfree in Europe and the UK

Building

Creating environments that serve life science innovation & global health

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EXPERT ENVIRONMENTS

E X P E R T E N V I R O N M E N T S

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 cleanroomprocess areas aswell as containment space. They are all self-contained and suitable for installation into an existing building or as a freestanding facility. 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 Europeanmarkets. The GermFree bioGO cleanroomsolution adapts to your business needs by optimising your company’s time-to-market and return on investment.

SCALEABLE

STACKABLE

INTERNAL EXTERNAL

READILY AVAILABLE

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G E R M F R E E A B O U T U S Global leader in biosafety and aseptic processes

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.

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.

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

Trusted Operational Readiness Partner Leader in Quality Risk Management Global Service Presence

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

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EXPERT ENVIRONMENTS

S O L U T I O N S O V E R V I E W

Rapidly deployable, scalable GMP manufacturing and laboratory facilities... 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 1. Mobile 2. Modular 3. Multi-Module

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 .

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M O B I L E 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.

Rapid deployment, self contained, GMP compliant Cleanroom trailers

AVAILABLE IMMEDIATELY WITH RENTAL OPTIONS (depending on availability)

70+ deployments globally

S I N G L E M O D U L E P O D Modular facilities are engineered and

Fully autonomous single module GMP Cleanroom facility.

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.

M U L T I - M O D U L E F A C I L I T I E S Interconnecting, multistorey units providing flexability and scaleabilty for all of your immediate and future requirements. Select from a number of application ready standard layouts or chose a more customised option

OPERATIONALLY READY WITHIN 10 MONTHS

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EXPERT ENVIRONMENTS

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EXPERT ENVIRONMENTS

S O L U T I O N S O V E R V I E W

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. We specialise in all forms of cleanroom construction, depending on your requirements:

– Modular Suite & MediPod – bioGO® Mobile Solutions

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G E R M F R E E M O D U L A R S O L U T I O N S

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

F L E X I B I L I T Y : Reconfigurable templates facilitate the ever-evolving ATMP space

S P E E D : Significant time savings vs. traditional

O P T I M I S E C A P I T A L I N V E S T M E N T : Scale your facility as your product

G E O G R A P H I C E X P A N S I O N : 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

development progresses through clinical into commercialisation and accommodate multiproduct pipelines. Rental options on our mobile GMP suites are available.

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EXPERT ENVIRONMENTS

H O W W E W O R K

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

OPERATIONS

TIME TO MARKET

REDUCED TIME TO MARKET

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View our time-lapse production video demonstrating rapid modular fabrication.

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EXPERT ENVIRONMENTS

C A S E S T U D Y Modular Cell and Gene Therapy ISO 7 Cleanroom Facility 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.

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. 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.

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

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C A S E S T U D Y Modular Biopharmaceutical Cleanroom/Production Facility A large National Public Health Organization had an urgent

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

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.

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

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EXPERT ENVIRONMENTS

Your European & UK Team Get in touch directly At Ardmac your enquiry will be dealt with promptly by our highly experienced Team

Ardmac Ireland Swords Business Campus Swords, Co. Dublin K67 D8H0 Ireland

Ardmac Manchester 4 Scholar Green Road Cobra Court, Trafford Park Manchester M32 0TR UK [email protected] +44 (0) 161 8668086 www.ardmac.co.uk

[email protected] +353 (0) 1 894 8800 www.ardmac.com

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

+1 (386) 265-4360

15 Copyright © Germfree 2021

EXPERT ENVIRONMENTS

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