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Large Pharma Client Mobile BSL-2 cGMP Cleanroom

Large Pharma Client Mobile BSL-2 cGMP Cleanroom

Client:
Large Pharma

Completion:
2020

Facility:
53′ Mobile BSL-2 cGMP Cleanroom

Application:
Therapeutic development for COVID-19

Location:
Midwest United States

A Mobile BSL-2 cGMP Cleanroom Delivered in Less than 3 Weeks

A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. Germfree provided a mobile facility that met both BSL-2 and cGMP requirements in less than 3 weeks. The facility had to have the ability to be repurposed for additional applications beyond the first application of therapeutic development for treating COVID-19. Germfree's standard trailer equipment package was supplied which assisted the commissioning and qualification of the facility within weeks of the project being delivered.
Project features

Size: 450 sq. ft

Layout configurations: 3-room layout

Facilities/Equipment:  Germfree biosafety cabinets, casework, laminar flow hoods, and pass-through boxes, autoclave and refrigerator

Features: Seamless primary walls, touchless door operation, total exhaust BSC’s, no shell building required

The challenge

Delivering a BSL-2 and cGMP compliant cleanroom in less than 3 weeks

The answer

The extremely rapid client timeline was by far the biggest challenge and required modification from our standard mobile laboratory platform to meet both cGMP and BSL-2 opposed to a ground up custom build. Our engineering team made accommodations for the clients monoclonal antibody (mAbs) therapy development process utilizing total exhaust biological safety cabinets and 3rd party equipment to safely manage material flow in and out of the facility as well as storage.

When our client was working on developing a therapeutic for COVID-19 during the 2020 pandemic, they required a mobile cleanroom facility to prepare clinical trial materials. The mobile facility had to meet both BSL-2 and cGMP requirements and have the potential for future repurposing.

Germfree rose to the challenge and converted our standard 53′ mobile trailer design into a BSL-2 cGMP facility. As part of the standard trailer package, we included equipment like case work, biosafety cabinets, laminar flow hoods, pass-through boxes, autoclaves, and refrigerators. The facility was turned over to the client in less than 21 days, which included commissioning, third-party certification of hoods and facility, FAT, SAT and environmental monitoring testing.

At Germfree, we take great pride in having been a part of such a significant project that aimed to develop a therapeutic for treating COVID-19. It brings us great satisfaction to know that the clinical trials for the mobile facility have been completed. We believe that the mobile cleanroom will be a valuable asset in future clinical trials, and we are confident that our contribution to this project will have a significant impact on the development of effective treatments for COVID-19.

This facility was built on Germfree’s proven mobile biocontainment lab platform, click here to learn more about our Mobile Biocontainment Labs.

Mobile BSL-2 cGMP Cleanroom: Gallery

Read about the unique process we used to deliver this project and how we can deliver yours.

Learn about our process

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