Recombinant Human Serum Albumin (OsrHSA) Excipient Grade

Human serum albumin (HSA) is the most well studied plasma protein and an attractive macromolecular carrier due to its availability in pure form and its biodegradability, nontoxicity and non-immunogenicity. It has a serum half-life of approximately 20 days, and is widely used as a stabilizing component in pharmaceutical and biologic products, such as vaccines, cell and gene therapies and coatings for medical devices. Due to the potential existence of various infectious disease pathogens in the human blood, especially AIDS, hepatitis B and other viruses, these virus may be brought with HSA to the final products.
OsrHSA, a recombinant human serum albumin derived from rice grains, can provide an excellent solution to utilise a safer, more defined and consistent material. Compared to plasma human serum albumin (pHSA), OsrHSA has the same second and tertiary structure, physiological and biochemical properties with pHSA, while higher purity and excellent batch consistency.

The excipient grade OsrHSA has officially obtained the Drug Master Files (DMF) number (No. 029648) from US Food and Drug Administration (FDA) in 2015, which showed that the excipient grade OsrHSA has good safety and the rice expression platform has been highly approved by FDA and the international market. The rice expression platform is a world-leading technology and produces cost-effective OsrHSA that is safe and can help to satisfy an increasing worldwide demand for human serum albumin, thus open new doors in its applications and contribute to self-sufficiency in blood and blood products.

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Background

OryzHiExp - A Rice Endosperm Specific Expression Platform
OryzHiExp platform uses rice endosperm cells to express various recombinant proteins and small peptides at high levels. Through this platform, innovative animal-free protein products with a wide range of applications can be produced, such as OsrHSA, OsrhTF, OsrhFN, and other recombinant growth factors.
ADVANTAGES
• Elimination of the potential risk of viral and other unknown contaminants
• Avoid the quality changes from different batches, improve the repeatability of cellculture and experiment results
• Regulatory compliant with well-defined components
• Stable supply and manufacture capability at large scales to meet bulk processing needs
• Simplify the downstream bio-processing or biological research