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Mobile BSL-2 cGMP Indiana

Mobile BSL-2 cGMP Indiana

Client:
Large pharmaceutical company (confidential)

Completion:
2020

Facility:
BSL-2 cGMP cleanroom (biocontainment)

Application:
cGMP production of an investigational drug for a novel antibody therapy for treatment of mild to moderate COVID-19 illness

Location:
Indianapolis, Indiana

Self-contained mobile BSL 2 cGMP cleanroom facility for clinical phase manufacturing

A leading pharmaceutical client contracted Germfree to create a self-contained, mobile BSL-2+ cGMP facility for early-phase clinical trial manufacturing. This cutting-edge facility produced an investigational product, advancing a pioneering antibody therapy to treat mild to moderate COVID-19 cases.
Project features

Size: 420 sqm / 39 sqm gross area

Layout configurations: Self-contained cleanroom on a semi-trailer

Facilities/Equipment: Biosafety cabinets, laminar flow hoods, pass-throughs

Features: 53′ tractor trailer platform

The challenge

In addition to the challenge of speed of delivery, the facility had to meet cGMP requirements, to ensure the safety and quality of production of the investigational drug.

The answer

Germfree skillfully designed and built a self-contained BSL-2+ cGMP mobile cleanroom facility within a 53-foot semi-tractor trailer, dedicated to producing an investigational drug targeting mild to moderate COVID-19 cases. Outfitted with an advanced HVAC system and MEP, the facility met rigorous FDA cGMP compliance requirements.

During the initial COVID-19 crisis, Germfree rapidly supplied a stand-alone mobile BSL-2+ cGMP cleanroom for a prominent pharmaceutical company in Indianapolis, IN. Navigating the project’s intricacies, Germfree delivered, factory and site acceptance tested, and commissioned the facility in mere weeks, facilitating prompt, high-quality drug production to fight COVID-19. Germfree’s expertise played a crucial role during the global health emergency, bolstering vital medical research.

The facility featured all essential equipment, such as biosafety cabinets, laminar flow hoods, passthroughs, refrigerators, and PCR workstations. This structure of the facility was built using Germfree’s proven mobile biocontainment lab platform, click here to learn more about our Mobile Biocontainment Labs.

Gallery

Mobile BSL-2 cGMP Interior
Mobile BSL-2 cGMP Exterior

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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