OUR TECHNOLOGY
Isoagglutinins are plasma-derived IgM and IgG antibodies which recognize and bind to type A or B blood group antigens. The presence of isoagglutinin antibodies in plasma-derived products (particularly plasma for transfusion and IVIG) can give rise to serious side effects, such as haemolysis, depending upon the type of isoagglutinin present (A or B) and the blood type of the recipient.
Astrea Bioseparations has developed a next-generation chromatography adsorbent, IsoClear® XT, for the depletion of anti-A and anti-B isoagglutinins. Designed for effective isoagglutinin depletion, this newly developed resin consists of chemically synthesized trisaccharide blood group antigens attached to PuraBead® 6HF support matrix, offering a fully alkalistable platform.
IsoClear® A XT and IsoClear® B XT are manufactured exclusively by Astrea Bioseparations, produced in a controlled environment to ISO 9001 quality standard and are designed for isoagglutinin reduction from plasma and plasma-derived products in cGMP manufacturing processes.
Adsorbent uses
IsoClear® A XT and IsoClear® B XT are effective in the removal of anti-A and anti-B isogglutinins from plasma-related products, such as IVIG. The IsoClear® XT range provides an effective, efficient platform for the clearance of isoagglutinin antibodies, supporting the global demand for safer plasma products.
Key features
• Highly specific A and B trisaccharide blood group antigen ligands
• Ligands synthesized in house to give security of supply
• Utilizing PuraBead® 6HF 90 µm agarose support matrix
• Operational conditions up to 500 cm/h (up to 1 bar)
• Specific for anti-A, anti-B, and anti-A,B isoagglutinins (IgM and IgG isotypes)
• Superior isoagglutinin reduction
• Robust, long-life adsorbents capable of multiple cycles
• Fully alkali stable
Advantages
• Applicable with blood-derived compositions such as IVIG
• Excellent protein recovery including protective antibodies, coagulation, and thrombotic factors expected
• Easy-to-pack adsorbents
• Excellent flow properties
• Comprehensive regulatory support files
PRODUCT FORMATS
Bulk manufacture & supply
Astrea Bioseparations produces IsoClear® XT in volumes sufficient to meet the requirements of the largest biomanufacturing processes. Adsorbent batches are produced in Astrea Bioseparations’ controlled environment manufacturing facility under an ISO 9001 quality system.
Regulatory support
Astrea Bioseparations can provide customers with comprehensive regulatory support files for both IsoClear® XT adsorbents and can support customers with regulatory filings for their processes.
Commitment to quality
Astrea Bioseparations is honored to support the biopharmaceutical industry with products and services that help bring life-saving and improving medicines to market. Regardless of process scale, we are ready to build Purity by Design into each process to ensure quality and speed to market.
Ordering information
We also offer a range of larger pack sizes and prepacked columns for supply of bulk resins into cGMP development and manufacturing-scale processes.
IsoClear® A XT: Gel Slurry
FG00592-00025 IsoClear® A
FG00592-00100 IsoClear® A
FG00592-00500 IsoClear® A
FG00592-01000 IsoClear® A XT
IsoClear® B XT: Gel Slurry
FG00593-00025 IsoClear® B XT 25 mL
FG00593-00100 IsoClear® B XT 100 mL
FG00593-00500 IsoClear® B XT 500 mL
FG00593-01000 IsoClear® B XT 1000 mL
For more information on any supply matters please contact us at sales@astrea-bio.com.
Technical support
Astrea Bioseparations is a world leader in adsorbent manufacture and chromatography development and can provide full support and in-house training for the development of new applications and their implementation for biopharmaceutical manufacture.
