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Project Profile: CARsgen Therapeutics GMP Manufacturing Facility

This RTP facility will provide increased manufacturing capacity of autologous CAR T-cell products

MaryBeth DiDonna

MaryBeth DiDonna is lab design editor and digital events editor for Lab Manager. Her work for the lab design section of the publication examines the challenges that project teams...

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The opening of the CARsgen Therapeutics GMP Manufacturing Facility in Research Triangle Park, Durham, NC, will provide CARsgen additional manufacturing capacity of autologous CAR T-cell products for 700 patients annually. The RTP Manufacturing Facility will support the company's clinical studies and early commercial launch in North America and Europe. This 36,500 sq. ft. facility was completed in January 2022, and CRB was the firm that worked on the project.

Research Triangle Park lab - CARSgen
CRB spearheaded the design and construction of the new CARsgen cell & gene therapy space using its ONEsolution™ approach to deliver the project and meet aggressive goals.

Lab Manager spoke to Ryan Lowden, Project Director, CRB; and Jia Jia, PhD, Vice President Strategic Alliances and Operations, CARsgen Therapeutics, about this recent build. 

Q: What was the need for this facility? Is it replacing an outdated existing facility or accommodating new research/ a new program?

A: CARsgen plans to manufacture innovative CAR T cell therapy products in the RTP Manufacturing Facility to support its clinical studies and early commercial launch in North America and Europe. It is a newly designed start-of-the-art facility using an existing office complex. 

Q: What kinds of sustainability initiatives have been included in the design plan? Is the facility pursuing LEED certification or something similar?

A: This particular facility is not pursuing a LEED certification. However, CRB designs and constructs our projects with LEAN mindsets and behaviors. By default, the project is organized to maximize efficiencies and reduce waste in the design, execution of the work, and facility operation.

Q: Is there anything particularly unique or groundbreaking about your facility or the design plan?

A: This is a fast-paced project which adopted the design-build approach. To overcome the challenges of travel restriction, the teams of Project Pine took advantage of a hybrid work mode by which the decision-makers and the subject matter experts in different geographic locations provided on-site and remote support throughout the design and construction phases. The modular cleanroom panels were built off-site and then assembled on-site to shorten the logistics and construction turnaround time.  

Ribbon cutting of the CARSgen facility
CRB, CARsgen, and guests celebrate the grand opening of the newly completed CARsgen 37,000-ft2 clinical and early-stage commercial manufacturing facility in Durham, NC.

Q: What sorts of challenges did you encounter during the design/build process, and how did you overcome them? 

A: CARsgens need for an expeditious response during a pandemic was the first and most daunting challenge. We worked closely with their team to understand their needs and quickly converted those requirements into a concept design that met their technical, financial, and timeline objectives. Working with a great client in a collaborative environment allowed us to advance elements of the work in ways that would not be practical under any other delivery method. Their trust in CRB was critical to the success of the project. 

Specifically, we utilized the ONEsolution™ approach developed by CRB to identify and mitigate the obstacles that would potentially impede our path. Whether it was material shortages, reduced labor availability, supply chain disruptions, scope additions, or any of the myriad of challenges on a project, we were able to identify and mitigate the issues without impacting the project budget or schedule.