ISO Certificate Recombinant Human Albumin Off - White Powder Compliant With GMP

ISO certificate recombinant human albumin powder

Human serum albumin has been widely used as plasma expansion reagent. Because of its non-enzymatic activity and no immunogenicity, etc. HSA can also be used as excipient and stabilizer in a variety of pharmaceutical preparations and serum-free cell culture medium component. In addition, HSA is also used as a drug carrier due to its antioxidant properties, thereby conferring drugs better physicochemical properties. At present, most HSA products in the market are directly derived from human plasma.

On the one hand, due to the potential existence of various infectious disease pathogens in the human blood, especially AIDS, hepatitis B and other viruses. Thereby, these virus from human plasma will be brought with HSA to the final products. What’s more, the supply of human blood is limited. Therefore, it’s very urgent to search blood substitutes. The establishment and development of recombinant technology provide an important method for the acquisition of biological materials.

Healthgen Biotech has developed the rice endosperm cell expression platform (Oryz^HiExp), which has such advantages: high expression level, safety, scale-up easily, simple production process and environmental protection etc. Using this advanced technology, Healthgen Biotech has expressed and purified the human albumin (OsrHSA) from rice grain. The OsrHSA has high purity, more than 99%, and low endotoxin, less than 0.125EU/mg, and is animal origin free, which effectively avoid any potential risk of animal contaminants, bacteria, prions, virus and contagious protein disease.

Healthgen Biotech’s Quality Control System has been certified by ISO 9001: 2015 and ensures standardized process as well as qualified products. Our scale production facility is compliant with GMP.

Physical Appearance: Off-white to light beige lyophilized powder

Formulation: It is lyophilized with saline

Purity: More than 99% as determined by SDS-PAGE and HPLC analysis.

Endotoxin: Less than 0.125EU/mg

Supplemental Description

Healthgen Biotech has strong technical force and advanced and complete protein expression and purification technology development and large-scale production facilities. Self-developed rice endosperm cell expression platform (Oryz^HiExp), which is domestic initiative and the international leader, has such advantages: high expression level, safety, scale-up easily, simple production process and environmental protection etc. After 10 years of unremitting efforts, Healthgen Biotech has established recombinant protein expression and purification technology platform to customize recombinant protein or peptide expression and purification process service for pharmaceuticals, health products, scientific research and industrial reagents. Using the Oryz^HiExp platform, Healthgen Biotech has achievements in developing and commercializing a series of medium ingredients, including recombinant human albumin (OsrHSA), recombinant human α-1 antitrypsin (OsrhAAT), recombinant human lactoferrin (OsrhLF), recombinant human basic fibroblast growth factor (OsrhbFGF), recombinant human epidermal growth factor (rhEGF), recombinant human insulin-like growth factor-1 LR3(rhIGF-1 LR3), recombinant human fibronectin (OsrhFN) and recombinant human Lysozyme (OsrhLYZ), which can provide a full set of solutions for animal component free cell culture medium.