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cGMP Viral Vector Production Cleanroom Trailer

Manufactured to meet the U.S. Food and Drug Administration’s (FDA) current Good Manufacturing Practice (cGMP) regulations, guidelines and recommendations. The Vector Production Facility develops and manufactures cGMP quality master cell banks and viral vectors encoding T cell receptors or chimeric antigen receptors for the ex vivo genetic modification of T lymphocytes. The trailer will also be used during the assessment of the Intravenous Admixture Unit (IVAU), which produces pain and other pharmaceuticals for the current patient population.

Client:
National Institute of Health
Completion:
November 2016
Project Type:
Mobile BSL-2
Application:
Viral Vector
Location
Maryland

Construction Project

Germfree has more than five decades of experience in biological safety equipment manufacturing. Our systems are installed worldwide and meet the demands for bio-containment at the highest levels.

Our engineers have designed a unit that combines the ideal layout, functionality and quality of construction with practical economic considerations.

Many factors contribute to the performance of a BSL-2+ laboratory. These include core fundamentals such as inward airflow and the integration of Class II Biological Safety Cabinets. BSL-2+ facilities also require optimized decontamination capabilities which include installation of an autoclave and rugged, sealed, chemically-resistant interiors.

Best Benefits of Project

Idea

Idea

An organization realizes the need for a biocontainment solution and seeks out Germfree's expertise.

Design

Design

Germfree works closely with the organization to determine project needs and suitable solutions.

Build

Build

The project enters offsite production at Germfree. FAT testing before shipment.