Choi Yejin, Kwon Seong Yi, Oh Ho Jung, Shim Sunbo, Chang Seokkee, Chung Hye Joo, Kim Do Keun, Park Younsang, Lee Younghee
Vaccines Division, National Institute of Food and Drug Safety Evaluation, 187 Osongsaengmyeoung 2-ro, Osong-eup, Heungdoek-gu, Cheongju-si, Chungcheongbuk-do, 28159, Republic of Korea.
Department of Biochemistry, College of Natural Sciences, Chungbuk National University, Cheongju-si, Chungcheongbuk-do, 28644, Republic of Korea.
Biotechnol Lett. 2017 Sep;39(9):1375-1380. doi: 10.1007/s10529-017-2372-8. Epub 2017 Jun 13.
The single radial immunodiffusion (SRID) assay, used to quantify hemagglutinin (HA) in influenza vaccines, requires reference reagents; however, because centralized production of reference reagents may slow the emergency deployment of vaccines, alternatives are needed.
We investigated the production of HA proteins using recombinant DNA technology, rather than a traditional egg-based production process. The HA proteins were then used in an SRID assay as a reference antigen. We found that HA can be quantified in both egg-based and cell-based influenza vaccines when recombinant HAs (rHAs) are used as the reference antigen. Furthermore, we confirmed that rHAs obtained from strains with pandemic potential, such as H5N1, H7N3, H7N9, and H9N2 strains, can be utilized in the SRID assay. The rHA production process takes just one month, in contrast to the traditional process that takes three to four months.
The use of rHAs may reduce the time required to produce reference reagents and facilitate timely introduction of vaccines during emergencies.
用于定量流感疫苗中血凝素（HA）的单向放射免疫扩散（SRID）检测需要参考试剂；然而，由于参考试剂的集中生产可能会减缓疫苗的紧急部署，因此需要替代方法。
我们研究了使用重组DNA技术而非传统的基于鸡蛋的生产工艺来生产HA蛋白。然后将HA蛋白用作SRID检测中的参考抗原。我们发现，当使用重组HA（rHA）作为参考抗原时，基于鸡蛋和基于细胞的流感疫苗中的HA均可进行定量。此外，我们证实从具有大流行潜力的毒株（如H5N1、H7N3、H7N9和H9N2毒株）获得的rHA可用于SRID检测。rHA的生产过程仅需一个月，而传统过程则需要三到四个月。
使用rHA可能会减少生产参考试剂所需的时间，并有助于在紧急情况下及时引入疫苗。
