Application of Animal‑Free Recombinant Human Albumin in CGT Field

Human serum albumin (hSA), the most abundant protein in human plasma, functions as a transporter for hormones, lipids and other substances. Its key physiological roles include regulating plasma pH and maintaining plasma osmotic pressure. In China, the batch release volume of human albumin increased from 400 tons in 2016 to 650 tons in 2022. Driven by huge clinical demand, over 60% of domestic supply relies on imports. Since 1981, global researchers have attempted to replace plasma‑derived human albumin with recombinant human serum albumin. However, due to bottlenecks in safety, large‑scale production and cost, relevant products have not yet been commercially launched.

Recombinant human albumin (rHA) developed by Anruite is expressed and purified from Pichia pastoris via genetic recombination technology. The eukaryotic expression system of Pichia pastoris enables high‑purity, low‑cost and ultra‑large‑scale production of rHA. Its molecular structure is nearly identical to that of serum albumin naturally synthesized in the human liver. Containing no animal‑derived components, it fundamentally avoids shortages of plasma raw materials and immunogenic risks, and eliminates blood‑borne viral contamination. With superior batch‑to‑batch stability, it can replace plasma‑derived albumin as a pharmaceutical excipient and has wide applications in the biopharmaceutical industry.

Core Applications of Albumin in Biopharmaceutical Industry
1. Promoting Proliferation and Differentiation of Stem Cells
As a common component of cell culture media, albumin supports the growth of various cells and enables highly reproducible differentiation of human stem cells, including mesenchymal stem cells (MSCs), embryonic stem cells (ESCs), induced pluripotent stem cells (iPSCs) and immune cells.
Albumin performs multiple physiological functions in stem cell culture:
(1) Serving as a nutrient source to support stem cell proliferation;
(2) Acting as a free radical scavenger, heavy metal chelator, stabilizer and surfactant to eliminate toxins, proteases and other harmful substances that impair cell growth;
(3) Binding to vitamins, hormones and other agents, transporting them into cells to accelerate cell growth;
(4) Transporting and complexing metal ions and beneficial molecules to build an ideal microenvironment for sustained cell viability;
(5) Preserving the activity of stem cells during cryopreservation.

2. Reducing Physical Damage in Cell Culture
Eukaryotic cells, especially mammalian cells, are vulnerable to physical stress in bioreactors. Albumin effectively protects eukaryotic cells from damage. Evidence shows that a low concentration of albumin (1 g/L) significantly reduces cell lysis in mammalian cell cultures in pilot‑scale airlift bioreactors or bubble‑free aeration membrane bioreactors. Combined with other additives such as antifoams and Pluronic (shear protectant), albumin delivers optimal protective effects. It is widely acknowledged that albumin optimizes the physicochemical properties of cell culture systems to prevent physical cell damage.

3. Stabilizer & Protectant for Biological Products
Besides being a major additive in cell culture media, human serum albumin acts as a stabilizer and protectant for biological products, preserving active ingredients from degradation and inactivation. It provides excellent protection for protein activity, especially in lyophilized products.
Albumin maintains vaccine stability by preventing physical damage during vaccine production and processing. It transfers its high thermal stability to formulated vaccines to sustain vaccine efficacy, making it a proven and safe excipient for vaccines.

4. Plasma Volume Expander & Adjuvant Therapeutic Agent
As a plasma volume expander and clinical emergency drug, albumin is widely used for shock caused by blood loss, trauma and burns, as well as edema and ascites induced by liver cirrhosis and nephropathy. It treats hypoalbuminemia, neonatal hyperbilirubinemia, cerebral edema and hypertension caused by injuries. It also serves as an adjuvant therapy in hemodialysis and burn treatment. Additionally, it transports substances, detoxifies the body and stabilizes globulin.

5. Coating Material for Medical Devices
With its inherent biological properties, recombinant human albumin is extensively used in biocompatible medical device coatings, such as coatings for stents and catheters in dialysis, to enhance biocompatibility.
Polymeric hydrogels composed of rHA and polyethylene glycol (PEG) are innovative materials in the medical device sector. Rapid cross‑linking of the two components forms an adhesive hydrogel matrix, enabling more effective surgeries such as thoracic surgery and pulmonary air‑leak repair. Furthermore, the recombinant production process eliminates risks of human pathogens and viruses, improving product safety.

Core Advantages of Products from Beijing Anrate Biotechnology Co., Ltd.

1.Higher safety: Zero animal‑derived components, eliminating risks of animal‑source contamination;
2.Greater reliability: Ton‑scale production capacity with consistent batch‑to‑batch performance, supporting unlimited single‑batch supply;
3.Stable supply chain: All production materials are domestically sourced to ensure supply chain security;

Important Notice