Recombinant protein A의 short-term stability에 관한 연구

• Accepted : 2011.06.07
• Published : 2011.06.25

Abstract

The purpose of this experiment is to evaluate the stability of products according to the storage methods, the period of use, and the diurnal variations through the short term stability experiment of recombinunt protein A (rProtein A) produced in AP Tech Co. That is, we investigated how long the stability of the products would last, when we used the samples frozen at $-20^{\circ}C$, which is one of the storage conditions of the produced rProtein A and then kept them refrigerated at $4^{\circ}C$. The experiment was conducted for 8 weeks and 6 experiment points were established. The experiment was done by thawing the samples frozen at $-20^{\circ}C$ at room temperature, and then refrigerating them at $4^{\circ}C$. In addition, experiments for endotoxin, bioburden, HPLC purity, and concentration were conducted. As a result of the experiment, 0.5 EU/mg endotoxin was detected both at the beginning and at the 8th week and bioburden was not analyzed. In the case of purity, it showed 99.23~99.90% at 210 nm (RSD% 0.23%) and 100% at 280 nm, which meant the change into other materials didn't happen and there was no material degradation characteristics. Finally, we also found the fact that the concentration stayed stable at 55.15 mg/mL (RSD% 0.55%) both at the beginning and at the end. From the experiment results, we were able to conclude that the stability at the condition to store rProtein A at 4 oC for 8 weeks was procured without producing microorganisms or having material degradation characteristics.

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