Advancing plasma purification with proven performance, regulatory confidence, and long-term partnership
A long-standing commitment to plasma biomanufacturing
Astrea Bioseparations is a long-standing partner to the global than three decades of experience in chromatography development, regulatory integration.
From its early work in chromatographic separation through to its current role as a specialist provider of purification technologies, the company remains focused on enabling safe, scalable production of plasma-derived therapies.
Plasma-derived medicinal products depend on human donor material, making plasma both valuable and limited. This places constant pressure on manufacturers to maximize recovery, maintain consistency, and operate within strict regulatory frameworks. These constraints shape process design and influence how technology partners are selected.
Astrea Bioseparations’ chromatography technologies have been incorporated into licensed manufacturing processes, supporting both clinical and commercial-scale production. The company operates at the interface of science, regulation, and large-scale manufacturing, contributing to the evolution of purification approaches used in plasma processing.
This experience has been built through long-term collaboration with plasma fractionators, supporting
purification strategies that integrate with established facilities, validated processes, and existing regulatory approvals.
As demand for plasma-derived therapies continues to increase, manufacturers require solutions that improve performance without introducing unnecessary risk. Astrea Bioseparations focuses on delivering reliable, industrially proven technologies that support yield, consistency, and regulatory compliance.
Core capabilities: Chromatography expertise designed for plasma realities
Astrea Bioseparations’ core capabilities are centered on chromatographic purification technologies developed specifically for plasma processing. Plasma is a complex and variable biological material, requiring technologies that combine selectivity, operational stability, and reproducability at industrial scale.
Chromatography plays a key role in modern plasma manufacturing by enabling targeted purification while maintaining high recovery. It complements established fractionation processes, improving product quality and impurity removal without disrupting validated workflows.
The company has particular strength in immunoglobulin and albumin purification, where yield, consistency, and process economics are critical. Mixed-mode and affinity-based technologies enable efficient IgG and albumin purification alongside targeted impurity removal.
Astrea Bioseparations also provides solutions for polishing and purification of other plasma proteins, supporting manufacturers in maximizing recovery from each plasma pool. All technologies are developed with scalability in mind, ensuring reproducible performance across large volumes and multiple manufacturing sites.
Through this focus on practical, proven solutions, Astrea Bioseparations supports plasma fractionators in improving efficiency, maintaining compliance, and sustaining long-term production performance.
Regulatory standing: Embedded in licensed manufacturing
Regulatory compliance is fundamental to plasma manufacturing, shaping process design, validation, and operation. Astrea Bioseparations delivers chromatography solutions aligned with these requirements, supporting both technical performance and regulatory expectations.
Astrea Bioseparations’ technology has been integrated into licensed plasma manufacturing across a broad cross-section of the industry, including collaborations with organizations such as the American Red Cross and major global plasma fractionators. Its solutions support validated purification processes for both clinical and commercial production, including plasma-derived treatments for rare diseases.
These technologies underpin purification cascades used in widely adopted therapies such as IVIG, as well as specialized programs including FDA-approved rare disease treatments. Continued use in commercial manufacturing reflects long-term regulatory acceptance and process reliability.
Astrea Bioseparations’ solutions are designed for GMP environments, with a focus on reproducibility, traceability, and product safety. This supports validation activities and integration across global manufacturing networks.
What matters to plasma companies: Partnership, security, and sustainability
The plasma industry operates under structural constraints. Plasma supply is limited, manufacturing is complex and capital intensive, and regulatory oversight is stringent. These factors shape how manufacturers evaluate process changes and select technology partners.
Supporting
Astrea Bioseparations’ approach is aligned with these requirements, focusing on three areas that consistently influence decision-making:
• Partnership
• Security of supply
• Environmental responsibility
Partnership is a key consideration. Plasma manufacturers work with partners who support process development, validation, and ongoing optimization within established frameworks.
Astrea Bioseparations collaborates closely with customers to understand workflows and constraints, enabling solutions that integrate with existing processes.
Security of supply is equally critical. Plasma-derived therapies are essential medicines, and interruptions directly impact patient availability. Astrea Bioseparations supports this through robust manufacturing, consistent product performance, and technologies designed for extended operational lifetimes.
Environmental responsibility is also an increasing focus. Traditional fractionation relies heavily on solvent use, particularly ethanol. Chromatography supports more selective purification with reduced environmental impact. Astrea Bioseparations contributes through PuraBead®, manufactured using a solvent-free process, and by working with fractionators to reduce waste while maintaining suitability for large-scale manufacture.
These factors reflect how plasma manufacturers assess both technologies and partners. Astrea Bioseparations supports incremental improvements that strengthen yield, consistency, and operational resilience.
Core competencies in plasma purification
Intravenous immunoglobulin and albumin represent the foundation of plasma-derived therapeutics. They are highvolume products with well-established clinical applications and significant economic importance within fractionation facilities. Astrea Bioseparations has developed deep expertise in the purification of both protein classes, supporting manufacturers in optimizing yield, purity, and process stability within established manufacturing frameworks.
IVIG purification
While traditional cold ethanol fractionation remains widely used, it is increasingly complemented by chromatographic methods that offer greater selectivity and process control. This is particularly important given the complexity of IVIG, which is derived from large pooled plasma sources and must meet stringent requirements for safety, viral clearance, and consistency. Regulatory scrutiny continues to increase, particularly around isoagglutinin titers, as these antibodies can cause hemolytic reactions in patients.
Astrea Bioseparations’ chromatography technologies are designed to integrate into IVIG purification workflows using a high-flow, alkali-stable PuraBead® platform designed for largescale, multi-cycle operation.
Astrea Bioseparations’ key chromatography solutions for IVIG purification include:
• Mixed-mode resins for selective IgG capture and purification
• Immunoaffinity resins for targeted isoagglutinin removal and polishing
• Ion exchange chromatography resins for impurity clearance, including IgA and aggregate removal
PuraBead® has superior perfromance to market leading products
Albumin purification
Albumin, as the highest-volume plasma protein, presents a distinct set of manufacturing priorities. Production must be highly efficient, reproducible, and cost-effective, with strong emphasis on throughput and process stability. Astrea Bioseparations’ chromatography solutions support albumin purification by enabling selective capture and efficient removal of co-purifying plasma proteins, while maintaining the robustness required for large-scale manufacturing. These technologies are designed for consistent performance under repeated cleaning and sanitization conditions, supporting long operational lifetimes and stable process economics.
Astrea Biosepartions’ key chromatography solutions for albumin purification include:
• Affinity-based resins for selective albumin capture from plasma fractions
• Ion exchange chromatography resins for removal of residual plasma proteins and impurities
• Mixed-mode and boronate-based resins for specialized applications, including glycated albumin separation
Beyond IVIG and albumin, Astrea Bioseparations provides chromatography solutions for the polishing and purification of additional plasma proteins. These technologies enable more selective impurity removal, improved product quality,
and enhanced process control, supporting manufacturers in maximizing the value of each plasma pool and aligning with industry priorities around yield optimization and resource efficiency.
PuraBead® technology: Robust, industrial chromatography
Astrea Bioseparations’ PuraBead® platform is built around a highly engineered agarose bead designed for industrial plasma processing. At scale, performance depends not only on ligand chemistry, but on bead properties such as packing consistency, flow behavior, and mechanical stability.
PuraBead® resins are manufactured using a controlled process that produces a narrow particle size distribution, enabling reproducible column packing and stable flow distribution. This reduces channeling risk and supports consistent performance in large-scale columns.
Key characteristics include:
• Narrow particle size distribution for consistent packing and flow
• Uniform bead structure supporting stable hydraulics
• Mechanical strength for high flow rates and long campaigns
• Chemical stability under repeated cleaning and sanitization
Derived from agarose sourced from red seaweed, the matrix is produced using a fully aqueous process, reducing environmental impact and eliminating solvent handling. The result is a durable, scalable platform suited to both capture and polishing applications.
Manufacturing excellence: Built for reliability, scale, and continuity
Astrea Bioseparations’ manufacturing capabilities support the demands of large-scale plasma fractionation, ensuring consistent supply, product performance, and regulatory compliance.
Recent investment in capacity, including expanded production on the Isle of Man, strengthens support for global demand. This enables:
• Increased production capacity aligned with market growth
• Flexible scheduling for routine supply and demand fluctuations
• Scalable manufacturing for process transfer and expansion
Security of supply is embedded in operations, with resilient infrastructure and long-term capacity planning supporting continuity.
Manufacturing is conducted within an ISO 9001-aligned quality framework, ensuring traceability, batch consistency, and compliance with GMP expectations.
Astrea Bioseparations’ integration into Biotage further strengthens its ability to deliver reliable, scalable supply through combined manufacturing expertise and global infrastructure.
A partner for the future of plasma processing
The plasma industry continues to evolve, driven by increasing demand, more stringent regulatory expectations, and a growing focus on sustainability, while operating within the inherent limitations of plasma supply.
Meeting these challenges requires technologies that improve predictable performance without disrupting established processes. It also requires partners with the experience to operate within regulated environments and support long-term production.
Astrea Bioseparations brings over three decades of experience, with technologies embedded in licensed manufacturing and long-standing industry relationships. Its combination of technical expertise, manufacturing capability, and regulatory understanding enables reliable support across both current operations and future demands.
By focusing on incremental innovation and operational robustness, Astrea Bioseparations supports the continued availability, safety, and consistency of plasma-derived therapies. For plasma manufacturers, this translates into a partner trusted to deliver consistent performance over time.
For further information on how Astrea Bioseparations can support your plasma purification processes, we would be happy to explore your specific requirements.
