OUR TECHNOLOGY
A range of insulin analogues have been commercially developed by varying the amino acid sequences of natural insulin, altering its ADME (adsorption, distribution, metabolism and excretion) characteristics in glycaemic control. Insulin analogues are generally either fasteracting (i.e. offering a better post-prandial profile) or longer-acting (i.e. to supply the basal level during the day or providing overnight control) than natural insulin, offering advantages for diabetes mellitus management.
Insulin analogues are recombinant proteins, often produced in microbial expression systems and are commonly purified using a combination of downstream process steps such as reverse-phase HPLC, ion exchange or size exclusion chromatography. Due to the growing demand to reduce the number of process steps and overall cost of purifying insulin analogues, Astrea Bioseparations developed a high performance synthetic ligand affinity chromatography adsorbent which is compatible with large-scale process applications.
Insulin Adsorbent shares the same chemistry as Astrea Bioseparations’ proven Mimetic Ligand™ adsorbents and provides high yields and purities for naturally occurring forms of insulin and insulin analogues from a variety of sources. Exclusively manufactured by Astrea Bioseparations in our controlled environment manufacturing facility in accordance with an accredited ISO 9001 quality management system, Insulin Adsorbent is supported by a comprehensive regulatory support file.
Key Features
• Uniform particle size PuraBead® 6HF
• Selective for most forms of insulin including single chain & two chain insulin
• Binding capacity up to 25 mg insulin per mL adsorbent
• High purities & yields
• Cost effective & reliable
• Robust, reusable adsorbent
• Excellent Regulatory and Technical Support
Advantages
• Stable non-toxic chemical synthetic ligand
• PuraBead® HF agarose base matrix manufactured in-house giving security of supply and minimal lead times
• Chemically stable in all commonly used buffers and solutions
• Solvents not required during operation
• Easy to clean, sanitizable using 0.5 M NaOH
Excellent flow properties
Insulin Adsorbent is an easy to pack chromatography adsorbent and the PuraBead® 6HF near monodisperse agarose beads give excellent flow properties, allowing the product to be used at operational flow rates of up to 600 cm/h, with low column back pressures.
PRODUCT FORMATS
Bulk Manufacture & Supply
Astrea Bioseparations supplies bulk adsorbents for developmental and regulated cGMP manufacturing applications in volumes sufficient to meet the requirements of the largest biomanufacturing processes.
Insulin adsorbent is manufactured in Astrea Bioseparations’ controlled environment manufacturing facility under an accredited ISO 9001 quality system and is supported by a comprehensive regulatory support file.
Ordering information
For small orders up to 500 mL, please visit our webshop.
We also offer a range of larger pack sizes for supply of bulk resins into cGMP development and manufacturing scale processes.
Adsorbent Gel Slurry
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.
Astrea Bioseparations also offers a range of pre-packed columns including 1 mL and 5 mL column kits and other pre-packed solutions. For information on any aspects of supply please contact us at sales@astrea-bio.com
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.
