Albumin Fusion Protein

Recombinant human serum albumin (rHSA) fusion proteins are proteins formed by the fusion expression of a target protein with albumin. They can extend the in vivo half-life of the target protein and have broad application value in the biomedical field.

As early as 1992, European scientists attempted to fuse the genes of albumin and CD4 protein, then express the fusion product in a yeast system for HIV treatment. In 2014, GlaxoSmithKline (GSK) launched albiglutide, a GLP-1 receptor agonist used for the treatment of type 2 diabetes. This drug is composed of two tandem GLP-1 molecules fused with rHSA, featuring long-acting properties—requiring only one injection every 1–2 weeks—and can effectively help patients manage their blood glucose levels.

In 2016, Idelvion (developed by CSL Behring) was approved for marketing by the U.S. Food and Drug Administration (FDA). This product is a fusion protein of coagulation factor IX and rHSA, which has a longer half-life in the blood and is used for the treatment of hemophilia B.

In addition, many other types of albumin fusion proteins are currently in the clinical trial stage, such as growth factor-rHSA fusion proteins, interleukin-2 (IL-2)-rHSA fusion proteins, antibody fragment-rHSA fusion proteins (e.g., scFv-rHSA fusion proteins), and interferon alpha-2b (IFN-α-2b)-rHSA fusion proteins. 

AlbuPure® Chromatography Resin

AlbuPure® is an albumin affinity chromatography resin co-developed by Astrea Bioseparations and Albumedix. The resin matrix is highly cross-linked agarose with a uniform particle size, and the ligand is a synthetic triazine compound. It features high flow rate, high dynamic binding capacity, and strong chemical resistance, and is mainly used for the purification of albumin fusion proteins. The performance parameters of AlbuPure® are shown in the table below.

AlbuPure® exhibits excellent binding performance for albumin fusion proteins. As shown in Figure 4, researchers investigated the dynamic binding capacity (DBC) of AlbuPure® for scFv-rHSA under loading conditions with different pH values and flow rates. The results indicated that AlbuPure® achieves the optimal dynamic binding capacity for the target fusion protein at a pH of 4.5 and a linear flow rate of 240 cm/h—when 10% breakthrough occurs, the binding capacity reaches as high as 38.4 mg/mL.

Figure 4. Study on Dynamic Binding Capacity of AlbuPure®

Similar to Mimetic Blue® SA HL P6XL, AlbuPure® affinity chromatography resin also exhibits excellent chemical stability. It can withstand cleaning with 1 M NaOH solution and has good compatibility with common denaturants, surfactants, reducing agents, and other substances.

In a research test, researchers expressed the Anti-HIV gp41-rHSA fusion protein (72 kDa) using a yeast system. After clarification of the harvest solution, the sample was loaded onto a chromatography column packed with AlbuPure®. The chromatography process parameters are shown in the table below:

As can be seen from the chromatogram in Figure 5 and the SDS-PAGE analysis results in Figure 6, AlbuPure® can efficiently capture the Anti-HIV gp41-rHSA fusion protein. Contaminant proteins flow through during sample loading; after three washing steps at different pH values, the small amount of contaminant proteins that remain bound to the resin can be further removed. Finally, the target fusion protein is eluted from the column using sodium caprylate, achieving extremely high purity.

Figure 5. Chromatogram of Anti-HIV gp41-rHSA Fusion Protein Purification Using AlbuPure®

Figure 6. SDS-PAGE Analysis Results

Lane: 1. Load (diluted); Lane 2: FT (neat); Lane 3: post load wash (neat); Lane 4: wash 1 (neat); Lane 5: wash 2 (neat); Lane 6: wash 3 (neat); Lane 7: elution (diluted); Lane 8: elution (10 fold dilution of lane 7); Lane 9: human albumin standard (1μg)

AlbuPure®Ordering Information

Bulk Resin

Prepacked Column

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Astrea Bioseparations was spun out of the University of Cambridge in 1987. With over 30 years of experience in the R&D and manufacturing of chromatography media, it is a world-class supplier of chromatography media products and services. To date, more than 21 manufacturing processes using Astrea’s products have obtained approvals from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Astrea Bioseparations has 3 R&D and manufacturing facilities worldwide, focusing on providing industry-leading chromatography media and technical services for the biopharmaceutical (large molecule) and Cell & Gene Therapy (CGT) sectors. The novel nanofiber-based chromatography technology launched by Astrea Bioseparations addresses the issues of low capacity and time-consuming processes associated with traditional bioseparation tools. It enables faster, more environmentally friendly, and more cost-effective purification processes, fully aligning with the needs of today’s biotherapeutic innovation.

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References

1. 人血清白蛋白融合技術(shù)在藥物長效化改造中的應(yīng)用，生命科學(xué)，第27卷，第9期，2015年9月

2. R. Raoufinia et al., Overview of Albumin and Its Purification Methods, 2016

3. M. Sanches et al., AlbuCORE: an albumin-based molecular scaffold for multivalent biologics design, 2020

4. Technical User Guide:  Mimetic Blue® SA HL P6XL, Astrea Bioseparations

5. Application Note: Capture and purification of human serum albumin from human source plasma using Mimetic Blue® SA HL P6XL, Astrea Bioseparations

6. Technical User Guide: AlbuPure®, Astrea Bioseparations

7. Technical Note: Capture and purification of recombinant albumin-fusion proteins using AlbuPure®, Astrea Bioseparations