AMP GMP Facility Design for Gene Therapy Manufacturing

ABOUT THE PROJECT

AMP needed a Good Manufacturing Practices (GMP) facility to support small-batch, patient-specific treatment production that also had the flexibility to operate as a contract development and manufacturing organization (CDMO) for other gene therapy innovators. Our team designed a 44,500-square-foot facility that included GMP manufacturing suites, R&D and analytical laboratories, office and administrative space, a controlled warehouse, and a freezer farm – each engineered for reliability, compliance, and future scalability.

OUR SOLUTION

We engineered a highly controlled, reliable environment to meet the demanding requirements of viral vector manufacturing and GMP validation. Our scope included:

• MEP/FP/FA and IT/AV/Security system design to support research, manufacturing, and administrative functions.
• Cleanroom design for Grade B, Grade C, and Grade D suites per EU GMP standards, including pressurization, air change rates, and biosafety containment for viral vector processing.
• Generator-backed power systems to ensure full facility uptime and protect against costly process interruptions.
• High-purity gas distribution systems, which used stainless steel piping and filtration to maintain production integrity.
• Integrated Building and Energy Management Systems (BMS/EMS) for operational control and efficiency.

THE IMPACT

Our design provided AMP with a GMP-validated facility capable of producing advanced gene therapies safely and reliably, supporting their mission to accelerate treatment development for genetic disorders and enabling future expansion for CDMO operations.

ABOUT AMP

AMP was a biotechnology company advancing customized gene therapy manufacturing. The company discontinued operations prior to facility occupancy as a result of changes in parent-company investment priorities.