IsoClear A and B ™
www.astreabioseparations.com
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2 | IsoClear A™ and B™
OUR TECHNOLOGY Isoagglutinins are antibodies (IgM and IgG isotypes) which recognise 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 have developed two affinity chromatography adsorbents (IsoClear A™ & IsoClear B™) comprising of immobilized trisaccharide blood group antigens (A & B). These antigens are chemically synthesized and covalently attached to a biocompatible polymethacrylate support matrix. IsoClear A™ and IsoClear B™ adsorbents are highly selective for the removal of isoagglutinin antibodies, enabling cost effective and efficient reduction of isoagglutinin titre for plasma and plasma derived products.
Key Features • Highly specific A and B trisaccharide blood group antigen ligands • Ligands synthesised in house to give security of supply • Biocompatible polymethacrylate base matrix • Operational conditions up to 500 cm/h (up to 1 bar) • Specific for anti-A, anti-B & anti-A,B isoagglutinins (IgM and IgG isotypes) • High performance (> 97% isoagglutinin clearance from plasma) • Robust, long life adsorbents capable of multiple cycles
Advantages • Applicable with most blood derived compositions including plasma, serum and IVIG • Excellent protein recovery including protective antibodies, coagulation & thrombotic factors • Easy to pack adsorbents • Excellent flow properties IsoClear A and IsoClear B 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. ™
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• Comprehensive regulatory support files
Adsorbent Uses IsoClear A™ and IsoClear B™ are effective in the removal of anti-A and anti-B isoagglutinins from a number of products including plasma, IVIG and serum and provide a cost effective and efficient platform for the clearance of isoagglutinin antibodies, supporting the global demand for safer plasma products.
IsoClear A™ and B™ | 3
PRODUCT FORMATS Bulk Manufacture & Supply
Ordering Information
Astrea Bioseparations produces IsoClear A and IsoClear B™ 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.
For small orders up to 500 mL, please visit our webshop.
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Regulatory Support Astrea Bioseparations can provide customers with comprehensive regulatory support files for both IsoClear A™ and IsoClear B™ adsorbents and can support customers with regulatory filings for their processes.
We also offer a range of larger pack sizes for supply of bulk resins into cGMP development and manufacturing scale processes.
Adsorbent Gel Slurry Pack Size
Product Code
25 mL
9301-00025
100 mL
9301-00100
500 mL
9301-00500
1000 mL
9301-01000
Adsorbent Gel Slurry Pack Size
Product Code
25 mL
9302-00025
100 mL
9302-00100
500 mL
9302-00500
1000 mL
9302-01000
Astrea Bioseparations also offers a range of pre-packed columns. For more information on any supply matters please contact us at sales@Astrea-bio.com.
Commitment to Quality
Technical Support
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.
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.
+44 (0) 1223 433 800 | astreabioseparations.com sales@astrea-bio.com | techsupport@astrea-bio.com | quality@astrea-bio.com Global bases in North America, Canada and Cambridge UK HQ: Horizon Park, Barton Road, Comberton, Cambridge, CB23 7AJ, UK
IsoClear A™ and B™ - V1 All trademarks, trade names, trade dress, product names and logos appearing in this brochure are the property of Astrea UK Services Ltd. Copyright © 2022 Astrea Bioseparations Ltd. All rights reserved.