Human serum albumin (HSA) is responsible for 80% of the colloid osmotic pressure of plasma (25-33 mmHg). Its main clinical use is in maintaining colloid oncotic pressure and increasing circulating plasma volume with the typical dosage in excess of 10g per dose. HSA is isolated by fractionating human plasma, which entails possible contamination by viruses or prions. Healthgen Biotech Recombinant human serum albumin (OsrHSA) has been successfully produced using a patented rice endosperm. The OsrHSA purity is more than 99.99% and endotoxin is less than 0.01EU/mg. The structural and functional properties of OsrrHSA are similar to those of plasma derived HSA. The OsrHSA has finished the preclinical and is doing clinical trials phase I. In addition to its use as a plasma expander, OsrHSA has great potential as a biomaterial for other medical and pharmaceutically related applications.
Vaccine cell culture is the important part of the vaccine production. Vaccines are used in the control of human infectious diseases, so the safety of vaccine cell culture is very important. Healthgen OsrHSA is derived from rice grains, which is animal component free and has high purity and stability. The OsrHSA would facilitate the quality control of vaccine production. OsrHSA is preferred in vaccine cell culture.
The OsrHSA liquid also can be used to improve the stability of the vaccines in both the liquid and solid state as well as improved yields during the process of harvesting virus for vaccine preparation. The use of OsrHSA allows for the formulation of vaccine stabilizers that do not contain products of animal origin, non-recombinant human serum albumin or gelatin. The OsrHSA do not necessarily solely stabilize the virus against inactivation; also help to prevent the physical collapse of the freeze-dried material during lyophilization and subsequent storage in the solid state. Thus, OsrHSA would be advantageous to develop stabilizers which both directly stabilize the live virus against inactivation, as well as protect against physical collapse of the vaccine preparation in the lyophilized state. The recombinant human serum albumin has reported that used in the manufacture of M-M-R and live virus vaccine.
In the rotavirus vaccine production, the concentration of OsrHSA is 3g/L, the virus titer is 4.579 times, which higher than the control (without HSA).
In the rabies vaccine production, the titer results of VMM containing 0.3% pHSA and 0.3% OsrHSA are comparable.
Slightly sticky, yellow or brown transparent liquid
more than 99.99% as determined by SDS-PAGE and HPLC analysis.