Operation of an animal testing facility for genetically modified veterinary products

Ko, I-Ting

Abstract

In order to develop, manage, and establish a scientifically-based safety evaluation system for genetically modified (GM) veterinary products, the Animal Drug Inspection Branch (ADIB) built an animal testing facility in 2005. The facility has continually improved in its mission to conduct research on, and registration of GM veterinary products, by implementing quality management and equipment maintenance systems as well as personnel trainings throughout the years. This facility is a negative pressure bio-safety secondary animal house that is designed with double corridors and 12 animal rooms. The facility strictly implements bio-safety control procedures and workflows in accordance with the relevant regulations. Since 2008, the facility has completed 24 new animal biological product trials, 72 pre-development evaluation tests of animal vaccines, 13 R&D trials from the biotechnology industry, and 207 routine vaccine inspections. Every year, the facility performs a routine equipment, instrument, and environmental assessment, as well as updates equipment as necessary, reassesses the animal management program, and assesses the biological risk (via a recently introduced biological risk management system). The facility will continue to provide comprehensive services for the testing of GM veterinary products on an established basis, and will continue to review the costs, revenue and facility usage to achieve the most efficient use of its services.

Detection and phylogenetic analysis of avian paramyxoviruses 1 strains Isolated isolated in Taiwan from 2010 to 2018

Yu-Pin Liu

Abstract

Avian paramyxovirus 1 (APMV-1), synonymous with Newcastle disease virus, is a worldwide viral agent that infects various birds that is responsible for outbreaks of Newcastle disease, one of the most important diseases affecting poultry. In this study, 40 APMV-1 isolates collected from poultry, migratory birds, and resident birds from 2010-2018 in Taiwan were characterized phylogenetically. Our phylogenetic analysis of the complete fusion protein gene of the APMV-1 isolates, revealed that 39 of the 40 Taiwanese isolates were either closely related to APMV-1 class I genotype 1, or to class II genotypes I, VI or VII. One lone isolate met criteria for its designation as a novel genotype within class I. One sub-clade of sequences, that was nested within the class I sub-genotype 1.2, were closely related to those isolated from wild birds in North America. Viruses placed in class II sub-genotypes VI.2.1.1.2.1 and VI.2.1.1.2.2 were the dominant pigeon paramyxovirus 1 strains circulating during the last decade in Taiwan. All the Newcastle disease outbreak-associated isolates belonged to class II sub-genotype VII.1.1, which has been mainly responsible for the present epizootic in Taiwan. We conclude that at least five sub-genotypes of APMV-1 circulate among multiple avian host species in Taiwan. One genetically divergent group of APMV-1 should be considered as a novel genotype within class I, and migratory birds may play an important role in intercontinental spread of APMV-1.