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Mobile Advanced Therapies Facility: NIH cGMP Cleanroom Bethesda

Mobile Advanced Therapies Facility: NIH cGMP Cleanroom Bethesda

Client:
National Institute of Health

Completion:
2017, 2019

Facility:
(2) Mobile 53′ Viral Vector Production Facility

Application:
Viral Vector Manufacturing (VVM)

Location:
Bethesda, MD

Viral vector early clinical phase manufacturing: a mobile advanced therapies facility

The National Institute of Health encountered a temporary requirement for additional capacity in clinical-stage viral vector production. Confronted with this distinct requirement, Germfree was tasked with the unique responsibility of conceptualizing and realizing two mobile advanced therapies manufacturing facility tailored for the specific needs of the National Institute of Health in Bethesda, Maryland.
Project features

Size: (2) 53′ tractor trailers with ~ 400 sq ft / 121 m sq metres gross area

Layout configurations: Mobile cGMP cleanroom on two semi-trailer chassis with a 3 room, bidirectional layout

Facilities/Equipment: Two 4-foot Class II, type B2 Total Exhaust Biological Safety Cabinets (BSC), Building Management System (BMS), an Environmental Monitoring System (EMS)

The challenge

Germfree evaluated the specific needs of the NIH and facilitated the design and construction of a high-quality mobile advanced therapies facility that fully complies with cGMP requirements.

The answer

Tasked with a unique challenge, Germfree partnered with the National Institute of Health (NIH), Bethesda, Maryland, to engineer and construct two versatile mobile cGMP trailers for the production of advanced therapy products.

These mobile facilities were designed with adaptability at the forefront, operating effectively under both positive and negative pressure conditions. Complying with cGMPs and USP 797/800 regulations, each unit featured three distinct zones – an Entry, an Anteroom, and the main Production Cleanroom space. The Entry room was built to ISO 8 specifications, while the Anteroom and the Cleanroom were both constructed to the more stringent ISO 7 standards.

In the pursuit of excellence, Germfree outfitted each facility with state-of-the-art elements such as an ISO-7 cleanroom, complemented by a pair of 4-foot Class II Type B2 fully exhausted biological safety cabinets (BSCs), a sophisticated building management system (BMS), and an advanced environmental monitoring system (EMS). Additionally, Germfree facilitated the inclusion of production equipment, ranging from incubators and centrifuges to cell counters and cell sorters.

In November 2016 and 2017 respectively, Germfree successfully delivered these state-of-the-art mobile facilities to the NIH. It is a matter of immense pride for Germfree to have created a solution that not only fulfilled the NIH’s distinct requirements but also pushed the boundaries of what’s possible in this field.

This facility was built using Germfree’s proven mobile cGMP cleanroom platform, click here to learn more about our cGMP cleanrooms.

Read about the unique process we used to deliver this mobile advanced therapies facility and how we can deliver yours.

Learn about our process

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