February 18, 2025
rHu Albumin

rHu Albumin – A Life Saving Albumin Produced Recombinantly

Recombinant human albumin is a purified recombinant form of the protein albumin that is produced through recombinant DNA technology. Albumin is the most abundant plasma protein in the human circulatory system, where it acts as a transport and storage molecule. This is produced through genetic engineering techniques using hansenula yeast cells that have been modified with the gene that codes for human albumin production. The gene encoding human albumin is inserted into the yeast cells, which then produce and secrete recombinant albumin identical to human albumin. The albumin is then purified from the culture media.

Production and Regulation

The production process for rHu Albumin allows it to be manufactured in large quantities through fermentation rather than relying on scarce human blood plasma supplies. The fermentation process using engineered hansenula yeast is carefully controlled to optimize albumin production. Once secreted by the yeast cells, this is purified through various chromatography steps to remove other proteins and ensure it matches the purity and quality of human albumin derived from plasma. Strict quality control measures are implemented throughout the production process to ensure rHu Albumin meets all regulatory standards. Its production is regulated and approved by agencies like the FDA in the United States and EMA in Europe to ensure its safety, purity and therapeutic equivalence to human albumin.

Uses and Applications of rHu Albumin

Due to its similarity to endogenous human albumin, human albumin can be used to replace plasma-derived albumin for various clinical applications. Some major uses of human albumin include:

– Volume Expanders – As a colloid it can be administered intravenously to expand fluid volume in conditions like trauma, burns or hypovolaemia.

– Liver Disease – It is given to patients with cirrhosis or other liver conditions who have low endogenous albumin levels to restore oncotic pressure.

– Surgery – Human albumin is commonly used during surgery and in critial care settings to replace blood loss and maintain adequate fluid volumes.

– Protein Supplement – In conditions like nephrotic syndrome where rHu Albumin is lost in urine, rHu Albumin supplements help maintain proper protein levels.

– Pharmacological Uses – It improves the solubility and stability of many drugs and vaccines, allowing for new parenteral drug formulations.

Benefits of human albumin Over Plasma-Derived Albumin

While plasma-derived human albumin remains an important therapeutic, rHu Albumin offers several advantages:

– Unlimited Supply – Its production through microbial fermentation enables reliable, large-scale manufacturing not limited by blood plasma collection.

– Consistent Quality – The fermentation process results in a highly purified product with uniform quality from lot to lot, eliminating contaminant concerns.

– Freedom from BSE/TSE – Unlike plasma products, rHu Albumin completely eliminated any theoretical risk of transmissible spongiform encephalopathies like variant Creutzfeldt-Jakob disease.

– Hospital Cost Savings – The abundant supply and elimination of viral inactivation steps result in reduced production costs compared to plasma-derived albumin.

– Equivalent Safety and Effectiveness – Extensive clinical trials have demonstrated rHu Albumin has identical structure, function and safety/efficacy profile as human albumin.

Future Perspectives

With the growing global demand for albumin to treat various clinical conditions, rHu Albumin represents a safe and reliable solution given its unlimited scalability. Current research efforts are exploring new production systems that may further lower manufacturing costs. The use of human albumin can help alleviate the pressure on limited plasma supplies while avoiding infectious disease transmission risk. Looking forward, human albumin will continue expanding indications and playing a vital role in therapy areas like critical care, surgery, trauma and liver diseases worldwide.

*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it

Money Singh

Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc.

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