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Arranta Bio BSL-2LS cGMP facility

Arranta Bio BSL-2LS cGMP facility

Client:
Arranta Bio (Inceptor Bio)

Completion:
2020

Facility:
BSL-2LS cGMP facility

Application:
Phase I and Phase II Clinical Manufacturing Facility for Microbial Fermentation

Location:
Gainsville, Fl

Modular Innovation: Expanding CDMO Advanced Therapy Manufacturing Capability with BSL-2LS cGMP Facility

Our client sought to expand their manufacturing capacity in Gainesville, FL, by constructing a Phase I and Phase II clinical manufacturing facility for advanced therapies.
Project features

Size: 4,000 sq. ft

Layout configurations: 5 prefabricated modules, open ballroom concept

Facilities/Equipment:  cGMP manufacturing and mechanical mezzanine space

Features: Flexible utilities, removable window and door panels

The challenge

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.

The answer

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.

Arranta Bio's BSL-2LS cGMP Facility: Gallery

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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Service & support: cs@germfree.com