Recombinant human serum albumin OsrHSA successfully obtained the DMF from U.S. FDA

Source:Posted by Themecurve| Time:2015-12-16| Hits:97

OsrHSA(excipient grade), plant-derived recombinant human serum albumin independently developed by Wuhan Healthgen Biotechnology Corp.(hereinafter referred to as Healthgen Biotech), has officially passed the US Food and Drug Administration (FDA) certification and successfully obtained the Drug Master Files (DMF) number(No. 029648), which showed that Healthgen Biotech rice bioreactor has been highly recognized by the international market.

 

 

Currently, it has become a trend to replace blood-derived products with recombinant human albumin internationally, and the domestic market demand is also expanding year by year. At the same time, the production technology of plant bioreactors, especially the production technology and safety of recombinant proteins are becoming mature day by day.

 

Healthgen Biotech is a private company founded in 2006, focusing on developing and manufacturing a series of environmentally friendly and safe biopharmaceutical products by using the State-of-the-Art technological platforms: rice endosperm specific expression platform OryzHiExp and protein high purification platform OryzPur. After ten years of technical research, Healthgen Biotech has completed the transformation from independent innovation technology into large-scale production and has established a sound solid quality control system, having high capacity to express proteins or small peptides in the rice grain. The Quality Control System has been certified by ISO 9001: 2015 and ensures standardized process as well as qualified products. And the scale production facility is also compliant with GMP.

 

The OsrHSA(excipient grade) expressed from plant bioreactor have advantages of high expression, no animal components, safety, high capacity and stable supply, and can be used as excipient or stabilizer in other recombinant and biotechnology-based products, formulation in vaccine and other biologicals, agent in therapeutic apheresis, carrier of small molecular conjugation for half-life extension, and coating agent in medical devices.

 

Long press the QR code to identify the query link of excipient grade OsrHSA DMF number.

 

 

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