Advanced Therapy Medicinal Products
Advanced Therapy Medicinal Products
Advanced Therapy Medicinal Products (ATMPs) are a class of medicines that use genes, cells, or engineered tissues to repair, replace, or restore normal biological function. Unlike conventional therapies, ATMPs are designed to address the underlying causes of disease and may offer long-lasting or potentially curative outcomes.
Gene therapies introduce new or modified genetic material to treat, prevent, or diagnose diseases and are used in rare inherited conditions, cancer, and chronic illnesses. Cell therapies rely on modified or repurposed living cells, such as CAR‑T therapies for certain blood cancers, and neurological, eye, and spinal cord disorders. Tissue‑engineered products combine cells with supportive biomaterials to create replacements or to regenerate damaged tissues, and are used to treat severe burns, chronic wounds, and diseases of the heart, liver, and pancreas. Together, ATMPs enable highly personalized and regenerative treatments, offering new options for patients with limited or no effective conventional therapies.
Key Issues
The development and manufacture of ATMPs are more complex than those of traditional pharmaceuticals. One of the main challenges is biological variability, as cells from different donors or patients can behave differently, affecting growth, yield, and product performance.
Processes must incorporate robust biosafety measures to manage viral vectors and gene carriers, protecting both operators and the environment. Scaling production often requires multi-batch, parallel processing, adding operational and logistical complexity. Additionally, critical steps such as washing, formulation, freezing, and thawing can affect cell viability and consistency.
These factors drive the need for highly flexible facilities capable of supporting multi-product pipelines, rapidly evolving technologies, and increased use of automation and robotics. Designing for flexibility while maintaining segregation, accommodating discrete workflows, and optimizing layouts presents a key challenge. Integrated digital systems further enable control, traceability, and consistent performance across operations.
How Fluor Helps
Fluor brings more than 40 years of experience delivering current good manufacturing practice (cGMP) facilities and high-containment laboratories for safe handling of potent and biohazardous materials. Our integrated EPCM services span feasibility through commissioning and qualification, supporting ATMPs from clinical development to commercial production.
Fluor designs flexible, modular facilities using single-use and closed systems, enabling multi-product operations and discrete, product-specific workflows while maintaining containment and efficiency. By integrating digital twins, automation, and optimized layouts, Fluor enhances traceability, process control, and scalability, enabling real-time decision-making, patient-centric ATMP manufacturing, adaptable technologies and supporting future expansion.
Process Features
ATMP manufacturing begins with the collection of cells from either the patient (autologous) or a donor (allogeneic), typically through blood or bone marrow collection depending on the therapy. Cells are then selected and enriched using techniques such as centrifugation or magnetic separation. Genetic modification may be introduced using viral vectors, gene editing technologies, or transient delivery methods, enabling targeted therapeutic function.
The modified cells are expanded under tightly controlled conditions using systems ranging from culture bags and flasks to scalable bioreactors. Downstream operations are tailored to the therapy and may include washing, formulation, and cryopreservation to maintain viability during storage and transport. Final products may be delivered as cryopreserved cell therapies, combined with scaffolds for tissue engineering, or formulated into vector-based delivery systems, ensuring safe and effective administration to the patient.
Facility Features
ATMP manufacturing facilities are designed to meet stringent requirements for cleanliness, safety, and containment while enabling highly flexible, multi-product operations. Production areas are organized by cleanroom classification based on process openness, with airlocks and pressure cascades separating zones of increasing cleanliness. Supporting spaces, including gowning, media and kit preparation, and staging, operate under controlled pressure conditions to protect both product and environment. Biosafety levels are defined by process risks, with higher containment required for viral vectors, aerosol-generating steps, and human-derived materials.
To support diverse pipelines and evolving technologies, facilities incorporate flexible design strategies such as modular cleanroom suites, ballrooms, and convertible processing areas that can adapt to new equipment, robotics, and intensified processes. These environments must accommodate discrete event workflows, where patient-specific materials move through non-linear, parallel processing steps, requiring careful segregation and optimized material and personnel flows. Robotics and automation enhance flexibility by reducing operator intervention, standardizing operations, and enabling consistent performance across batches.
Digital systems, including manufacturing execution system and real-time data platforms, support traceability and performance data integration from cell collection through clinical delivery while improving planning, scheduling, process control across multi-lot operations, and optimization across the facility lifecycle.
Fluor Projects
Bayer AG Cell Therapy Launch Facility (B69)
Location: Berkeley, California, USA
Scope: Construction Management, Commissioning, Qualification, and Validation
Fluor provided construction services for a 144,000-square-foot state-of-the-art cell therapy manufacturing facility featuring 30,000 square feet of cleanroom space. We delivered advanced biopharmaceutical construction supporting therapies for neurological, cardiovascular, and other unmet medical needs. The facility achieved LEED v4 Platinum certification and earned ISPE 2025 Facility of the Year (FOYA) for Social Impact. This project builds on Fluor’s prior delivery of Bayer’s Cell Culture Technology Center.
Gene Therapy Facility
Location: North Carolina, USA
Scope: Construction Management, CQV, Field Engineering, and Start-up
Fluor provided CQV and construction management support for a recombinant adeno-associated virus gene therapy facility in North Carolina. The facility includes clean utilities, media and buffer preparation, plasmid and inoculation suites, and two purification and cell culture trains utilizing single-use bioreactors ranging from 500 to 2,000 liters. Services included startup leadership, field engineering, HSE supervision, and construction management oversight for therapies delivery.
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