The challenge was to design and fabricate a modular BSL-2LS cGMP facility that could adapt to the evolving business needs of a CDMO while maintaining robust primary engineering controls and unidirectional process flow.

Germfree provided a state-of-the-art solution by designing and manufacturing a BSL-2LS cGMP system from 5 prefabricated modules. The cleanroom facility was designed to allow unidirectional process flow and robust primary engineering controls for door management and interlocks. The facility includes approximately 4,000 sq. ft. of cGMP manufacturing space and mechanical mezzanines and was designed as an open ballroom. To provide adaptability and flexibility, the facility was designed with easily configurable utilities and removable window/door panels to meet the changing business needs of a CDMO. Germfree’s services for the project included commissioning and qualification to ensure the facility met all required standards for operation.

The BSL-2LS modular cGMP production facility was a groundbreaking project commissioned by ArrantaBio (now Inceptor Bio) to expand their production capacity in Gainesville, FL. The plant was designed to allow for unidirectional process flow and robust primary engineering controls, with an adaptable design to meet the evolving needs of a CDMO. The plant has been fully commissioned, qualification is underway, and it has since been sold to Inceptor Bio.

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