Development of An Inactivated Porcine Epidemic Diarrhea Virus Vaccine
Yu-Liang Huang,
Division of Hog Cholera Research
Abstract
A global pandemic of porcine epidemic diarrhea (PED) occurred from 2013 to 2014. This outbreak reached Taiwan in late 2013 and led to the death of numerous suckling pigs. After the 2013-2014 outbreak, PEDV became endemic in Taiwan and sporadic outbreaks currently occur every year in a number of small hog farms. Animal Health Research Institute (AHRI) analyses indicate that PED is currently the major cause of enteric disease in Taiwanese hogs. In order to prevent and control PED, an inactivated PEDV vaccine was developed by AHRI. Research and development activities on the inactivated PEDV vaccine, have included the selection of cell and strain lines, methods for inactivating PEDV, adjuvant selection, as well as antigen titer and vaccine efficacy tests. Next major steps include production of the prototype PEDV vaccine and the start of field trials.
Quality Control Testing of Biologics from 2016-2017
Cheng-chu Hsieh
Abstract
In 1988, we established a pharmaceutical factory at the Animal Health Research Institute (AHRI) that complied with GMP standard requirements. The main tasks of the biological products division are the production, development, storage and supply of vaccines and diagnostic reagents. AHRI currently possesses 21 manufacturing licenses for various biological animal products including Newcastle disease hemagglutination antigen, freze-dried lapinized hog cholera seed virus, pullorum disease antigen, frozen-dried lapinized hog cholera vaccine, bovine ephemeral fever inactivated vaccine, hog cholera tissue culture live vaccine, waterfowl parvovirus live vaccine, goat pox attenuated live vaccine, grouper iridovirus inactivated vaccine, and Riemerella anatipestifer (RA) inactivated trivalent bacterins (serotype 1, 2 and 6), among many others. An analysis of data from 2018-2019 shows that more than 20 different batches of biological preparations were manufactured each year, and each batch passed quality control and national inspections, thereby supporting domestic epidemic prevention and diagnostic efforts. To further improve the quality of biological animal products manufactured in Taiwan as well as their international competitiveness, we plan to “build a pilot plant for animal vaccines” from 2020-2023, which will comply with PIC/S GMP pharmaceutical factory standards, and drive indusrial animal vaccine development in Taiwan.