Contract Development and Manufacturing Organizations
Contract Development and Manufacturing Organizations
The pharmaceutical and biotechnology industries have experienced rapid growth in development pipelines, driven by the need for faster speed to clinic and an increasing diversity of therapeutic modalities. To meet these demands, companies are increasingly leveraging Contract Development and Manufacturing Organizations (CDMOs) to augment internal capabilities across clinical development and commercial manufacturing.
CDMOs have evolved from single-service providers into strategic partners offering end-to-end support across the product lifecycle, from early-stage development and process optimization to clinical supply and commercial-scale manufacturing. By partnering with CDMOs, organizations gain access to specialized technical expertise, advanced infrastructure, scalable manufacturing capacity, and state-of-the-art equipment. This model enables innovators to accelerate development timelines, manage risk, and efficiently bring high-quality drug products from concept to market.
Key Issues
CDMOs operate in a dynamic environment shaped by evolving supply chain strategies, increasing modality complexity, and shifting capacity demands. Facilities must support a broad range of modalities, including monoclonal antibodies (mAbs), antibody-drug conjugates (ADCs), peptides, messenger RNA (mRNA) therapies, viral vectors, and cell and gene therapies, each with distinct process, containment, and scalability requirements
At the same time, digital transformation is accelerating, with adoption of automation, integrated data systems, and advanced analytics to improve process control, enable real-time decision-making, and support efficient tech transfer across programs. Demand for capacity expansion is driven by growing biologics pipelines, increased outsourcing, and the need for rapid scale-up from clinical to commercial production. Balancing flexible facility utilization, cost efficiency and adaptable production strategies remain critical, due to variability in demand across emerging modalities, to maintaining competitive, future-ready CDMO operations.
How Fluor Helps
Fluor brings over 40 years of experience delivering complex cGMP facilities and high-containment laboratories for CDMO operations across diverse therapeutic modalities. Our integrated EPCM approach spans feasibility through commissioning and qualification, enabling safe, scalable, and efficient manufacturing of biologics, small molecules, cell and gene therapies, peptides, oligonucleotides, and ADCs.
Fluor designs flexible, future-ready facilities that support multi-product operations, rapid changeovers, and evolving client pipelines. By integrating advanced automation, digital manufacturing systems, optimized layouts, and robust utility infrastructure, Fluor enables reliable, high-quality production while improving facility utilization. This approach supports efficient tech transfer, accelerates clinical-to-commercial transitions, and positions CDMOs for sustainable growth in a dynamic market.
Process Features
CDMOs operate dedicated and flexible multi-product suites supporting a wide range of biologics and ATMPs, including mAbs, ADCs, recombinant proteins, vaccines, mRNA, and viral vectors. Modular, single-use systems are widely used in early- to mid-phase manufacturing, enabling rapid changeovers and reduced contamination risk.
Biologics typically scale using platform processes with single-use bioreactors up to approximately 2,000 L, while ADCs require segregated, high-potency containment with isolators, closed transfers, and controlled conjugation workflows. mRNA and viral vector production emphasize closed, automated systems supported by digital control platforms such as manufacturing execution systems (MES), distributed control systems (DCS), and real-time data monitoring. ATMP manufacturing favors segregation, multi-lot, scaled-out approaches with integrated fill-finish, where robust cold-chain handling is critical to maintain product stability, viability, and potency from production through patient delivery.
Facility Features
Future-ready CDMO facilities are purpose-built for flexibility, speed, and end-to-end digital manufacturing. Adoption of Pharma 5.0 technologies integrates robotics, automation, and advanced analytics to manage the complexity of biologics, cell and gene therapies, and multi-product operations. Autonomous material handling, robotic aseptic processing, closed single-use systems, and integrated platforms such as MES enable consistent, contamination-resistant manufacturing from raw material receipt through final drug product.
Digital twins, AI-driven process control, predictive maintenance, and real-time quality monitoring support right-first-time tech transfer and accelerated batch release. Real-time supply chain analytics improve resilience and responsiveness. Facilities emphasize modular, scalable layouts, continuous processing, and process intensification to reduce footprint, shorten schedules, lower energy use and emissions, and maximize productivity and cost-efficient drug supply.
Fluor Projects
CDMO Facility
Location: South Korea
Scope: Engineering
Fluor provided concept and basic design services for a CDMO campus in South Korea. The program includes three plants, with an initial facility featuring eight 15,000-liter production bioreactors and single-use operations with two 2,000-liter bioreactors, plus fill/finish and packaging. Scope included site infrastructure, utilities, warehouses, laboratories, administration, wastewater treatment, and support amenities supporting scalable biologics manufacturing and expansion across the campus footprint.
CDMO Facility
Location: Colorado, USA
Scope: Engineering and Construction Management
Fluor provided basic and detailed design and procurement services for a new facility that will manufacture advanced intermediates and chemically synthesized active pharmaceutical ingredients (APIs).
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