Determination of Remained Host Derived Proteins in the Commercially Available Biotechnological Products Using a Sandwich Enzyme Linked Immunosorbent Assay Method

Sandwich ELISA 방법을 이용한 생물공학의약품에 잔류하는 숙주유래단백질의 검출법개발

We obtained the total protein antibodies of Saccharomyces cerevisiae KCTC 1720 and Escherichia coli K-12 from the rabbit and the guinea pig to determine the host-derived proteins which may be remained in biotechnological products. The protein concentration of rabbit antibodies was 4.05 mg/mι in the case of yeast, 7.14 mg/mι in the case of E. coli and that of guinea pig antibodies was 1.90 mg/mι in the case of yeast, 7.17 mg/mι in the case of E. coli, respectively. To determine remained host-derived proteins in biotechnological products which produced by the hosts, S. cerevisiae or E. coli, we used a sandwich enzyme linked immunosorbent assay method in 96 well microplate. When the method applied to determine the remained host-derived proteins in commercial biotechnological products, it detected less than 3.5 ng/vial in human growth hormone, less than 1 ng/vial in hepatitis B vaccine and interferon-${\gamma}$ and 2~23 ng/vial in interferon-$\alpha$. The method can be used to determine the remained host-derived protein in biotechnological products.