Strategic Planning for cGMP Compliance in CAR-T Cell Therapy Facility Design

Genesis AEC partnered with 2seventy bio to strategically convert existing office space into a purpose-built cGMP clinical facility, essential for advancing their CAR-T cell therapy drug product development. Meticulous planning and early mapping of equipment and process requirements ensured adherence to stringent FDA and EMA regulatory standards, facilitating streamlined workflows for efficient cell therapy manufacturing.

Optimizing Workflows and Regulatory Standards for CAR-T Cell Therapy

Expert guidance from Genesis AEC ensured the facility design optimized personnel, material, waste, equipment, and product flows. This streamlined approach not only accelerated the project timeline but also ensured compliance with cGMP regulations.

Multi-Functional Clinical Facility for CAR-T Cell Development

The resulting multi-functional clinical space accommodates a wide range of operations essential for CAR-T cell therapy development. This includes:

• Two ISO-7/Grade B Process Suites Linked by Supply and Return Corridors

• cGMP Warehouse

• Controlled Rate Freezer and Drug Product Room

• Support Areas: Debox, waste, locker/gowning, media preparation, and kitting rooms

• ISO-7/Grade B PBMC Suite for Peripheral Blood Mononuclear Cell Processing

• QC Lab, Document Storage, and Clean Equipment Quarters

• Utility Infrastructure

Expedited Project Timeline and Regulatory Compliance for CAR-T Cell Therapy Development

This project exemplifies Genesis AEC’s expertise in transforming spaces for biomanufacturing, ensuring regulatory compliance, and accelerating the development of life-saving therapies. Our team integrated cGMP principles into the facility design and construction process to enable 2seventy bio to expedite their timeline while maintaining the highest quality standards.

This case study demonstrates the power of strategic planning, expert guidance, and adherence to cGMP regulations in transforming an office space into a cutting-edge clinical facility for their engineered T-cell therapy development. Genesis AEC’s expertise ensured efficient workflows, regulatory compliance, and ultimately, accelerated the development of life-saving therapies.