AlbuPure® Brochure

AlbuPure

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www.astreabioseparations.com

2 | AlbuPure®

OUR TECHNOLOGY Human serum albumin (HSA) has a vast array of applications within the biopharmaceutical industry, including as a fusion partner to extend the half-life of a protein drug while maintaining its activity. In order to support the rising production of a wide range of recombinant albumin fusion proteins, an affinity chromatography adsorbent has been developed that is highly stable, robust, non-toxic, and provides high binding capacity, recovery and purity: AlbuPure®.

AlbuPure®, developed in collaboration with Albumedix and manufactured exclusively by Astrea Bioseparations, is produced in a controlled environment to ISO 9001 quality standard and is designed for use in cGMP manufacturing of biological molecules.

The AlbuPure® adsorbent comprises a novel synthetic triazine ligand derived from Astrea Bioseparations’ Mimetic Ligand™ technology and is coupled to proprietary PuraBead® 6HF base matrix.

This proven technology provides a stable ligand and attachment chemistry with excellent selectivity for albumin fusion proteins and is compatible with the use of 1 M NaOH for cleaning and sanitization.

Key Features • High dynamic binding capacities • Robust and long-life adsorbent • Sanitizable using sodium hydroxide • Colorless ligand • Rugged and easy to pack - PuraBead® 6HF base matrix • Manufactured to ISO 9001 accredited standard • Supported with a comprehensive regulatory support file

Advantages • Proven Mimetic Ligand™ technology • Stable across a very wide pH range from pH 2.0 (short term) to pH 14.0 • Resistant to denaturants (urea, guanidine hydrochloride), detergents (Triton, SDS) and thiol-reducing agents • Can be sterilized by autoclaving at neutral pH • Stability data for up to 5 years at room temperature (long term storage at 2 - 30°C) • Reusable for multiple process cycles

Operational Flexibility The PuraBead® 6HF base matrix enables the operation of large diameter process columns at high linear flow rates (up to 600 cm/h).

AlbuPure® | 3

PRODUCT FORMATS Bulk Manufacture & Supply

Code

Description

Pack Size

Astrea Bioseparations supplies bulk adsorbents for developmental and regulated cGMP manufacturing applications in volumes sufficient to meet the requirements of the largest biomanufacturing processes.

6626

AlbuPure HT 1 mL Column Kit

4 x 1 mL columns

6627

AlbuPure® HT 5 mL Column Kit

4 x 5 mL columns

6628

HT-1 Albumin purification selection kit

2 x 1 mL AlbuPure®, 1 x 1 mL Mimetic Blue® SA P6HF, 1 x 1 mL Mimetic Blue® SA HL P6XL

6629

HT-5 Albumin purification selection kit

2 x 5 mL AlbuPure®, 1 x 5 mL Mimetic Blue® SA P6HF, 1 x 5 mL Mimetic Blue® SA HL P6XL

AlbuPure® 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.

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We also offer a range of larger pack sizes for supply of bulk resins into cGMP development and manufacturing scale processes.

Pack Size

Product Code

25 mL

3151-00025

50 mL

3151-00050

100 mL

3151-00100

500 mL

3151-00500

1000 mL

3151-01000

Astrea Bioseparations also offers a range of pre-packed columns including 1 mL and 5 mL column kits and a range of other larger pre-packed column solutions.

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

AlbuPure® - V3 AlbuPure® is a registered trademark of Albumedix Ltd. This product is covered by or for use under one or more patents: www.astreabioseparations.com/patents All other trademarks, trade names, trade dress, product names and logos appearing in this brochure are the property of Astrea UK Services Ltd. Copyright © 2023 Astrea Bioseparations Ltd. All rights reserved.