Our proven plasma regulatory
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.
Instead of relying solely on:
• Ethanol fractionation
• Plasma donor screening/exclusion
Reflects industry movement toward:
• Hybrid fractionation + chromatography models
• More targeted impurity removal
• Greater control vs. bulk precipitation
bulk impurity removal
immunoaffinity polishing
• 94% IgG
• Removal of albumin and IgM impurities
Beyond its primary capture function, Mimetic Blue® enabled fractionators to improve overall plasma protein recovery economics by increasing process flexibility within established Cohn-based trunk fractionation workflows. The resin was engineered for industrial robustness, including chemical stability under caustic cleaning and sanitization regimes required in GMP environments. This durability supports high cycle numbers and long operational lifetimes, key considerations in large-scale plasma fractionation where throughput, validation stability, and cost control are tightly linked.
Importantly, the integration of chromatographic albumin capture provided fractionators with a pathway to modernize operations incrementally, introducing adsorption-based selectivity without disrupting licensed processes. In this way, albumin chromatography became not only a purification tool, but a strategic lever for yield optimization, facility efficiency, and long-term supply resilience within regulated plasma manufacturing.
Regulatory-embedded plasma products
A defining milestone in the company’s plasma track record was the development of chromatographic cascades supporting plasma-derived therapeutics in both clinical and commercial manufacture. In collaborative programs involving the American Red Cross and pharmaceutical partners, a suite of fifteen chromatography adsorbents were developed specifically for plasma purification cascades.
• 96% ±1.8% average IgG recovery
• ≥2-titer isoagglutinin reduction
These partnerships supported multiple clinical programs and culminated in the world’s first intravenous rare-disease plasminogen product receiving U.S. FDA approval. The approved plasminogen therapy continues to be manufactured using chromatography products developed within Astrea Bioseparations platform, including a highly specific plasminogen capture ligand. This represents direct integration of Astrea Bioseparations’ technology into a licensed raredisease plasma therapeutic.
Parallel safety-focused initiatives led to the formation of Pathogen Removal and Diagnostic Technologies (PRDT), targeting affinity-based removal of variant Creutzfeldt–Jakob disease (vCJD) prions from blood and plasma. Ligand-based chromatography approaches for prion reduction subsequently informed plasma product safety paradigms, including those referenced in products such as OctaplasLG®, manufactured by Octapharma.
For rare diseases such as plasminogen deficiency, plasmaderived proteins may represent the only viable therapeutic option. Supply chain resilience therefore relies on validated, scalable purification technologies capable of maintaining regulatory compliance while maintaining yield. Astrea Bioseparations’ portfolio of chromatography solutions provided a pathway to achieve these objectives, ensuring critical patient access to rare-disease treatments.
Frederic Vanderhaegen, Chief Executive Officer, Astrea Bioseparations:
“Plasma and its derivatives are life-saving essentials for patients worldwide. We recognize that plasma supply is inherently limited, which makes it critical to maximize both its availability and safety.
At Astrea Bioseparations, we are proud to support manufacturers in increasing plasma yield while ensuring safer outcomes for patients globally. Through close collaboration with plasma fractionators, we help optimize process efficiency, strengthen product safety profiles, and enhance supply resilience.
As demand for plasma-derived therapies continues to grow, our focus remains consistent: delivering robust, scalable solutions that align scientific innovation with regulatory expectations, supporting sustainable access to these critical therapies for patients worldwide.
”Industry leadership and customer engagement
Throughout ProMetic’s evolution, the organization has worked alongside major plasma fractionators, biopharmaceutical companies, and institutional partners in collaboration with leading global plasma fractionators, as publicly referenced in industry publications.
In 2023, Astrea Bioseparations was acquired by Biotage AB, integrating its chromatography expertise into a global life sciences tools portfolio and strengthening its ability to serve regulated plasma biomanufacturing markets worldwide.
Across organizational transitions and industry evolution, the plasma mission has remained unchanged: delivering regulatory-grade chromatography solutions embedded within licensed plasma therapeutic manufacturing.
Today, Astrea Bioseparations maintains its position as a specialist provider of advanced chromatography resins and purification solutions for plasma proteins, supported by deep expertise in chromatographic separation tailored to demanding biomanufacturing environments. Its products continue to serve regulated plasma protein purification processes worldwide, affirming its sustained, technologydriven legacy in plasma regulatory support. Rather than operating as a conventional chromatography vendor, Astrea Bioseparations works alongside plasma fractionators worldwide as a long-term partner. We work to co-develop, validate, and sustain purification processes within regulated therapeutic manufacturing, supporting the alignment of scientific, regulatory, and manufacturing requirements to safeguard sustainable plasma-derived therapeutic supply for patients globally.
If you are looking to strengthen plasma purification performance, contact our team to discuss how we can support your workflow.