Plasma Derived Therapeutic Products (PDTs)
Plasma Derived Therapeutic Products (PDTs)
Plasma derived therapeutic products (PDTs) are essential medicines manufactured from human plasma. They treat a wide range of serious and life-threatening conditions, many cannot be produced using recombinant technologies due to technical or economic limitations. Product classes include immunoglobulins (IgG), coagulation factors, albumin, hyperimmune globulins, and specialized anti-inflammatory proteins. Plasma proteins are structurally complex, require human specific post-translational modifications, or exist as polyclonal mixtures that current recombinant systems cannot replicate. In other cases, such as albumin, the required global volumes make recombinant production commercially impractical.
In the United States, plasma-derived therapeutic products (PDTs) are regulated under a well-established biologics framework that begins with donor eligibility screening and plasma collection. Regulatory requirements are defined in 21 CFR Part 630, with additional standards in 21 CFR Parts 610 and 640 governing product testing, processing, and plasma quality. 21 CFR Part 640, Subpart G establishes specific requirements for source plasma collection, manufacturing controls, and quarantine-hold procedures that must be satisfied before plasma is released for further processing. Globally, plasma-derived products are expected to comply with internationally harmonized quality, safety, and risk-management frameworks to ensure consistent product quality and patient protection across markets.
Key Issues
Biosafety: Plasma, although extensively screened, may contain viral pathogens requiring robust containment and inactivation strategies.
Hazard management: fractionation processes involve flammable solvents and inert gases, requiring specialized fire protection and ventilation systems.
Ergonomics: Significant material handling, equipment movement, and maintenance activities require thoughtful facility layout and process design to minimize ergonomic risks and support worker safety.
Cold Processing: Many plasma fractionation operations are conducted at subzero temperatures, requiring cold rooms, insulated process equipment, and specialized HVAC systems capable of maintaining stringent environmental conditions.
Because cold ethanol fractionation employs flammable solvents, comprehensive process safety management systems are essential to mitigate fire and explosion hazards while meeting applicable regulatory requirements. Compliance with frameworks such as the ATEX Directives in Europe and NFPA 30 in the United States typically includes hazardous-area classification, lower explosive limit (LEL) monitoring, engineered ventilation, and appropriate fire and explosion protection measures. In addition, clear segregation of HVAC systems between solvent-handling and non-solvent areas is required to prevent cross-contamination and maintain safe operating conditions.
How Fluor Helps
Fluor brings more than 30 years of experience in project planning, estimating, feasibility and conceptual studies, basic and detailed engineering, construction, commissioning and qualification of regulatory‑compliant plasma fractionation, purification, fill‑finish, and secondary packaging facilities across North and South America, Europe, and Asia.
Process Features
Plasma fractionation facilities separate plasma into proteins through precipitation, filtration, chromatography, and viral inactivation steps. Most operate under cold chain conditions using ethanol-based Cohn or KistlerNitschmann fractionation as the primary separation platform, supported by downstream purification for immunoglobulins, albumin and coagulation factors. These facilities require precise control of process parameters, robust cleaning and validation systems, and reliable utilities such as chilled water, ethanol recovery, and cryogenic storage to ensure consistent product quality and regulatory compliance.
Facility Features
Features include refrigerated suites, high-bay areas for large vessels, ethanol-classified processing zones, segregation between clean, cold, and solvent-handling spaces. Designs emphasize safety, thermal stability, and long-term adaptability to evolving manufacturing technologies.
PDT manufacturing operates within the most stringent global regulatory frameworks, requiring facilities to demonstrate full compliance with FDA biologics regulations under 21 CFR Parts 210/211 and 600-680, as well as plasma-specific controls outlined in 21CFR 610 and 640 governing eligibility, collection, testing, processing, and quarantine requirements. These expectations are mirrored in the EU through Eudralex Volume 4, Annex 1 for sterile manufacturing, Annex 2 for biological products, Annex 15 for qualification and validation, and Annex 11 for computerized systems, all align with PIC/S PE 009-17 and WHO guidance for blood and plasma establishments.
Fluor Projects
Plasma Fractionation Facility
Location: Osaka, Japan
Scope: Engineering
Fluor provided concept, basic and detailed design services for two plasma fractionation projects in Japan. Scope included drug substance fractionation and purification, drug product filling, lyophilization, and packaging, supported by utilities and warehouse infrastructure. Designs enable up to 1,000,000 L/year plasma throughput and included LEED and energy conservation assessments that produced recommendations to enhance building efficiency.
Takeda (Formerly Baxalta/Baxter Formerly Shire) Biologics Facility
Location: Covington, Georgia, USA
Scope: EPCM
Starting 2012, Fluor provided EPCM and ongoing project management (PM) services for Takeda’s 100-acre plasma fractionation campus with 1 million square-feet of building space. The greenfield facility processes up to 3,000,000 liters annually across dual trains producing immunoglobulin and albumin therapies. Scope included process buildings, wastewater treatment, utilities, laboratory and admin. Fluor also supported feasibility studies to double immunoglobulin output, and continued PM services through 2024.
Read the expanded project profile here.
CSL Behring Everest Plasma Fractionation Facility Expansion
Location: Kankakee, Illinois, USA
Scope: Engineering and Procurement
Fluor provided engineering, procurement, and project services for CSL Behring’s plasma fractionation expansion in Kankakee, Illinois, supporting a multi-building facility comprising of seven-story manufacturing, warehouse space and plant utilities building. The project enabled three process trains producing 7.8 million liters annually. Other services included detailed design, equipment procurement, site selection, HVAC engineering for Building 21, B3/22 capper line support, and utilities modifications for Buildings 34 and 39 to expand manufacturing capacity.
Grifols (formerly Talecris) North Fractionation Facility
Location: Clayton, North Carolina, USA
Scope: EPCM
Fluor provided EPCM services for Grifols’ North Fractionation Facility expansion in Clayton, North Carolina. The project included a new 160,000 square-foot fractionation facility, utilities expansions, and a revamp of an ethanol fractionation plant, incorporating advanced centrifuge technology. Modular design and construction enabled an accelerated schedule. 6MM liters plasma/year fractionation capacity. Closed processing and minimal operator intervention to optimize compliance. Highly automated centrifugal separation and valve array fluid transfer. The project was recognized as the ISPE 2014 Facility of the Year for Project Execution.
Read the expanded project profile here.
Business Inquiries
Contact Fluor's sales team to learn how Fluor can help you with your business needs and what solutions Fluor offers in your industry. See the buttons below for questions on other topics.