Cornerstone® Services specialize in advanced plasma fractionation using CIM monolithic columns, ensuring high-quality purification of blood plasma components for biopharmaceutical applications. Our goal is to achieve safe and efficient separation of essential plasma proteins, such as immunoglobulins or clotting factors, for treatments in immunology and haematology. Our technology purifies proteins from traditional plasma fractionation processes, as well as from direct plasma or cryo-poor plasma loads. Analytical Development Services include monitoring product quantity and quality, assessing impurities, and measuring plasma protein concentration utilizing analytical LC with CIMac monoliths and PATfix® for comprehensive analysis. Additionally, we use nephelometry, coagulometry, and other assays for specific blood-derived targets.
Revolutionizing Plasma Purification with CIM Monoliths
Monolith technology is transforming plasma purification by enhancing efficiency, purity, yield, and process speed. The following case studies illustrate the impact of CIM monoliths in Cornerstone® Services, showcasing their role in
IgG Purification: Achieving High Recovery
The production and purification of immunoglobulins is the core of the plasma fractionation industry, addressing challenges such as obtaining large quantities of pure IgG at low cost, maintaining functional integrity, preserving subclass composition, and eliminating contaminants without compromising therapeutic properties. The backbone process, Cohn fractionation, involves shifts in pH and ethanol concentration at low temperatures. While variations exist, the fundamental principles remain consistent. A monolith-based method for IgG purification from Cohn I+II+III paste demonstrates high recoveries, achieving more than 95% for IgG. During purification, a fingerprint-based method using analytical monolithic columns allows for rapid and accurate characterization, facilitating fast decision-making.
Factor IX: Enhancing Process Efficiency
In plasma-derived Factor IX (FIX) purification, process speed and specific activity are prioritized over recoveries. CIM Monolithic columns offer high binding capacity, rapid method development, easy scale-up, reproducible results, and enhanced specific activity, providing higher yield and faster purification compared to conventional columns. Efficient purification of Factor IX is crucial for producing therapeutic products for hemophilia B and other bleeding disorders. Monolithic columns can also be applied to other proteins from human plasma.
Advanced Techniques for Plasma Proteins
Monolithic columns enable specific binding of target plasma proteins from undiluted cryo-poor or whole plasma, preserving physiological activity without activation. This allows direct processing of undiluted plasma, facilitating specific binding of target proteins. Unbound proteins remain available for further processing. Measurements before and after passing through the CIMmultus OH column show unchanged plasma properties, with no activation or coagulation.
Characterizing IgG with CIMac Technology
Human plasma-derived IgG is essential for treating immunodeficiencies, necessitating effective removal of protein contaminants. Fast and reliable characterization methods enhance traceability and robustness. Monolith technology, using CIMac r-Protein G and CIMac r-Protein A columns, supports real-time decisions in process chromatography, analyzing UV chromatograms to inform critical process steps. The PATfix monolithic-based method for characterizing IgG from Cohn fraction paste is also applicable.
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FAQ About Analytics Development Services
Monolith technology offers improved binding capacity, rapid method development, easy scale-up, reproducible results, and enhanced specific activity, leading to higher yields and faster purification compared to conventional methods.
Yes, monoliths can purify proteins from both traditional plasma fractionation processes and direct plasma or cryo-poor plasma loads, preserving physiological activity without activation.
We employ analytical LC with CIMac monoliths, PATfix®, nephelometry, coagulometry, and other assays to monitor product quantity and quality, assess impurities, and measure plasma protein concentration.
The purification process for IgG involves maintaining subclass composition and eliminating contaminants without compromising therapeutic properties, achieving high recoveries and preserving functional integrity.
These columns support real-time decisions in process chromatography by analyzing UV chromatograms, enhancing traceability and robustness in the characterization of human plasma-derived IgG.
By prioritizing process speed and specific activity, we use CIM Monolithic columns to achieve higher yields and faster purification, crucial for producing therapeutic products for haemophilia B and other bleeding disorders.
Our facilities are located in Ajdovscina, Slovenia. We can support you with process development in our modern, fully-equipped BSL 1 and 2 facilities. Take a virtual tour of our laboratories.
Consult Our Experts
Our experts would be happy to discuss your project. Fill the contact form below or send us an email to cornerstone@biaseparations.com
