Journal of Blood Disorders & Transfusion

Study for the development of in vitro method determining the potency of anti-tetanus human immunoglobulin

International Conference on Hematology & Blood Disorders

September 23-25, 2013 DoubleTree by Hilton Hotel Raleigh-Durham Airport at RTP, NC, USA

Yong Seok Kang

Posters: J Blood Disord Transfus

Abstract:

Anti-tetanus human immunoglobulin (hTIG) is biologics which is prepared by plasma fractionation and is administered for the prophylaxis or treatment of tetanus. For this purpose, it is essential to measure the accurate potency of hTIG. Currently, the potency of hTIG for quality control is tested by in vivo toxin neutralization assay. However, in vivo method is time-consuming, relatively expensive, and raises ethical issues regarding the use of live mammals. The aim of this study is to establish in vitro potency method based on enzyme-linked immunosorbent assay (ELISA). We developed in vitro method and compared with 2 commercial EIA kits. There was no significant difference between developed and commercial kits when statistically analyzing their precision and accuracy. The method validation study was conducted on developed EIA kit according to ICH guideline. All validation parameters including accuracy, precision, specificity, linearity and range satisfied the defined specification. Correlation study between currently used in vivo method and in vitro method couldn't show the correlativity because of the insufficient experiments, but importantly there was no statistical distinction of potencies obtained by in vitro and in vivo methods (p=0.2423). Finally, in vitro potency of national standard hTIG candidate was tested collaboratively in 3 laboratories. The candidate hTIG standard material was assigned a potency of 37.15 international units (IU) per vial by the international standard hTIG (NIBSC, TE-3). In conclusion, we developed a reliable EIA kit for in vitro hTIG potency assay. However, further study is needed to confirm that the developed in vitro assay can be used as an official quality control test.

Biography :

Yong Seok Kang has completed his Ph.D. from Gwang ju Institute of Science and Technology. He is currently the scientific officer of blood product team, National Lot Release Center of South Korea.