Our proven plasma regulatory track record Astrea Bioseparations’ plasma heritage spans more than three decades of chromatography development, industrialization, and regulatory integration. From its origins as ProMetic BioSciences to its evolution as Astrea Bioseparations, the organization has remained focused on a clear objective: advancing chromatographic purification for plasma-derived therapeutics within validated, licensed manufacturing frameworks.
From the outset, the emphasis was on modernizing plasma fractionation, particularly for albumin and immunoglobulins. Chromatographic processes were developed to complement and enhance traditional Cohn ethanol fractionation and more modern separation techniques, enabling selective adsorption rather than precipitation-driven recovery. Key industry pioneers, including Steve Burton and John Curling, contributed to this pivotal transition, laying the groundwork for highyield purification processes while preserving the established regulatory foundation of licensed plasma products.
IVIG and albumin: Core of the plasma platform Intravenous immunoglobulin (IVIG) and human serum albumin (HSA) have been central to the company’s plasma legacy. Chromatographic technologies developed within the ProMetic lineage were applied to IgG purification from Cohn fractions II & III, improving selectivity and enabling integration with advanced downstream purification steps. Triazine-based ligands, used in such resins as MiMode PuraBead® HL3, were engineered for industrial robustness, caustic stability, and repeated sanitization, requirements essential for GMP plasma manufacturing. These innovations enabled modern chromatography IVIG workflows that reduced reliance on solvent-heavy, Cohn-based fractionation methods. Astrea Bioseparations has also played a central role in the development and manufacture of the industry’s first immunoaffinity chromatography resins designed specifically
for isoagglutinin polishing in IVIG production, with IsoClear® XT. These highly selective ligands were engineered to target and remove anti-A and anti-B antibodies from IgG preparations with precision, while preserving overall product yield and functional integrity. The introduction of dedicated immunoaffinity polishing represented a significant advancement over traditional fractionation-only approaches, enabling plasma fractionators to more tightly control isoagglutinin titers within regulatory expectations. By incorporating these resins into validated downstream purification cascades, manufacturers were able to enhance batch-to-batch consistency and strengthen product safety profiles without disrupting established licensed processes. This technological step-change directly contributed to a measurable reduction in hemolysis-related adverse events associated with IVIG therapy, reinforcing both regulatory confidence and patient safety. In doing so, Astrea Bioseparations immunoaffinity platform marked a new benchmark for safety-driven chromatographic refinement within plasma-derived therapeutics. Albumin purification has been equally foundational. Mimetic Blue® was developed for selective albumin capture and removal, supporting both direct albumin production and optimization of upstream IgG purification cascades. As the highest-volume plasma protein globally, albumin is critical not only for therapeutic supply but also for the economic sustainability of fractionation facilities.
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