Prefabricated Viral Vector Modular BSL-2LS cGMP Facility Designed, Built, Installed and Commissioned in 13 Months
When Vibalogics, a German-based CDMO, sought out Germfree, it was at a pivotal point in its business development. As the company looked for ways to expand its reach into the U.S. CDMO market for viral vectors, it needed a facility with a larger footprint capable of supporting three processing lines up to 2 x 2,000 liters in size with fill finish capacity.
Size: 12,000 sq. ft. of cleanroom and mezzanine space
Layout configurations: 9 prefabricated modules, open ballroom concept with a high hat to accommodate 2 X 2000L bioreactors
Facilities/Equipment: Cleanroom for unidirectional process flow, flexible utilities, removable window and door panels
Germfree was awarded the opportunity to design and fabricate a modular BSL-2LS cGMP facility that accommodated the desired scale while ensuring unidirectional process flow and comprehensive engineering controls.
Germfree provided an innovative solution by designing and manufacturing a modular BSL-2LS cGMP facility consisting of 9 prefabricated modules. The facility includes approximately 12,000 sq. ft. of cGMP manufacturing and mechanical mezzanine space and incorporates an open ballroom concept with a high hat to accommodate 2 X 2000L bioreactors. The facility layout incorporates strong segregation to support multiple campaigns occurring at the same time.
Given the nature of starting materials and the substrates/agents being manufactured, this facility was built to meet the Center for Disease Control (CDC) guidelines for biosafety level 2 Large Scale (BSL-2LS). The facility has onboard VHP distribution that allows for manufacturing suites to be biodecontaminated between campaigns as an added risk control.
Prefabricated modules supported the accelerated timeline by manufacturing the cleanrooms while the primary site was under demolition and renovation. This reduced the overall project duration by several months.
Germfree’s team of experts created a state-of-the-art BSL-2LS cGMP facility that was carefully engineered to provide unidirectional process flow and robust primary engineering controls to ensure a safe and efficient working environment. The facility was designed with configurable utilities and removable window/door panels. In addition, the plant’s flexible design allows it to adapt to the ever-changing needs of a CDMO.
This facility was built using Germfree’s proven modular cleanroom platform, click here to learn more about our modular cleanrooms.