Major Global Albumin Manufacturers
The production of medicinal albumin is a specialized process, and as such, it is handled by a select group of global manufacturers with the capacity for large-scale plasma collection and processing. These companies are leaders in the field of plasma-derived therapies.
- CSL Behring: A global biotechnology leader, CSL Behring is a major producer of albumin solution derived from blood plasma donations. The company operates manufacturing facilities, such as its site in Kankakee, Illinois, where it refines and processes human plasma into therapeutic albumin products. CSL Behring supplies its products worldwide and emphasizes long-term partnerships to ensure a reliable source of albumin.
- Grifols: A Spanish multinational pharmaceutical and chemical manufacturer, Grifols is another key player in the albumin market. They produce Human Albumin Grifols from human plasma, following the Cohn cold alcohol fractionation method, and have their products approved in numerous markets. The company sources its plasma from FDA-approved plasmapheresis centers.
- Takeda Pharmaceutical Company Limited: As one of the largest pharmaceutical companies in the world, Takeda manufactures human albumin products, such as their Human Albumin 20% solution, used for various fluid replacement and hypoalbuminemia treatments. Takeda acquires plasma from blood donors and ensures rigorous viral testing and inactivation steps during manufacturing.
- Kedrion Biopharma: An Italian company with a significant global presence, Kedrion manufactures and distributes albumin, including its product KEDBUMIN®. In 2022, Kedrion joined forces with BPL (Bio Products Laboratory), significantly expanding its plasma collection and product portfolio globally.
- Bio Products Laboratory (BPL): Based in the UK and now part of Kedrion, BPL has decades of experience in manufacturing plasma protein therapies. Their albumin products, such as ALBUMINEX, are derived from human plasma and are available in various concentrations for medical use.
The Albumin Manufacturing Process: From Plasma to Product
The journey of albumin from a plasma donation to a final medicinal product is a complex and highly regulated process. The most widely used method is the Cohn cold ethanol fractionation process, followed by steps to ensure the product's safety and purity.
- Plasma Collection: Albumin is sourced from donated human plasma, collected through a process called plasmapheresis at licensed donor centers. Each donation is meticulously screened for infectious agents.
- Fractionation: The pooled plasma undergoes a process known as Cohn fractionation, where varying temperatures and ethanol concentrations are used to precipitate specific plasma proteins. Albumin is separated in the final stages of this process.
- Purification: The precipitated albumin fraction (Fraction V) is further purified. Modern manufacturers often employ an additional chromatography 'polishing' step to increase purity and remove impurities like endotoxins and aluminum.
- Viral Inactivation: To mitigate the risk of transmitting infectious agents, manufacturers employ rigorous viral inactivation steps. A common method is pasteurization, where the solution is heated to 60°C for 10 hours.
- Formulation and Filling: The purified and sterilized albumin solution is then formulated into specific concentrations (e.g., 5% or 25%) and filled into sterile vials or bags.
Human Plasma vs. Recombinant Albumin
While most therapeutic albumin is derived from human plasma, recombinant albumin, produced through genetically engineered organisms, also exists. This alternative is used in specific biopharmaceutical and research applications.
- Human Plasma-Derived Albumin: The gold standard, with extensive clinical history. It is a derivative of human blood and carries an extremely remote risk of viral transmission, though rigorous screening and inactivation processes minimize this risk.
- Recombinant Albumin: This form is not derived from human blood, eliminating the risk of transmitting human blood-borne pathogens. It is primarily used in specialized applications like biopharmaceutical manufacturing and in drug delivery. Companies such as InVitria are involved in the production of recombinant albumin.
Comparison of Major Albumin Manufacturers
| Feature | CSL Behring | Grifols | Takeda | Kedrion Biopharma | BPL |
|---|---|---|---|---|---|
| Primary Manufacturing Method | Cold ethanol fractionation, viral inactivation, and pasteurization. | Cold alcohol fractionation, heat treatment. | Plasma fractionation, viral testing/inactivation. | Cold ethanol fractionation, pasteurization. | Cold ethanol fractionation, chromatography, pasteurization. |
| Main Product Source | Human plasma donations. | Human plasma donations (US FDA-approved centers). | Human plasma donations. | Human plasma donations. | Human plasma donations (US FDA-licensed facilities). |
| Key Brands | Albuminar, AlbuRx. | Human Albumin Grifols, Albutein. | Takeda Human Albumin. | Kedbumin, Albuked. | Albuminex. |
| Noteworthy | Emphasizes long-term collaborations for sustainable supply. | Leader in plasma protein therapeutics, large global footprint. | Focus on developing and launching novel therapies, large market share. | Expanded global presence by joining forces with BPL. | High purity, chromatography-based process. |
Conclusion
In summary, the manufacture of pharmaceutical-grade albumin is a complex, multi-stage process dominated by a few global leaders. Companies like CSL Behring, Grifols, Takeda, Kedrion, and BPL utilize advanced plasma fractionation techniques, rigorous viral inactivation methods, and strict quality controls to produce this vital medication. While the majority of therapeutic albumin is derived from human plasma, recombinant alternatives are also available for specific uses. Continuous advancements in the industry ensure that patients worldwide have access to these life-saving therapies with a high degree of safety and purity. For further information on human albumin, its functions, and applications, you can visit Grifols' dedicated albumin resource page.
