3Rs implementation in veterinary vaccine batch-inspection and method establishment

I-Ting Ko

Abstract

 The Animal Drugs Inspection Branch conducts batch-by-batch testing of all types of veterinary vaccines according to the criteria outlined in the "Test Standards of Veterinary Drugs." Following the principles of replacement, reduction, and refinement (3Rs) in animal experimentation, we have implemented changes in veterinary vaccine inspection techniques since 2020, especially regarding large batch inspections or the use of medium to large animals in testing. These changes included: (1) evaluating the rationality of animal numbers used for each testing standard based on scientific validation methods and historical testing results to reduce animal usage in experiments; (2) developing molecular biology techniques or in vitro testing methods as substitutes for animal testing; and (3) establishing serological methods to replace experimental challenge tests, thereby minimizing animal suffering. By 2023, 17 sections of the Test Standards of Veterinary Drugs have been established or revised following the 3Rs principle. Legal processes and announcements have also been completed, significantly reducing experimental animal use required for batch inspections. Domestic veterinary vaccine manufacturers can also adhere to the updated regulations during in-factory quality control inspections, benefiting from reduced reliance on experimental animals. We will continue inventorying and allocating resources to develop new testing methods, adopt international standards, and adjust regulations to enhance testing quality and improve the welfare of experimental animals.

Application of next generation sequencing on studying avian influenza and other diseases

Yu-Pin Liu

Abstract

Compared with traditional nucleic acid sequencing methods, next generation sequencing (NGS) has the advantages of high-throughput, cost and speed, and has been widely used in the fields of pathogen identification and genome sequencing. In recent years, high pathogenicity avian influenza (HPAI) viruses have caused severe epidemics globally, and poultry cases appeared in Taiwan in 2015. Analyzing genomic sequences of avian influenza virus extensively broadens our understanding of biology and ecology of this heavily impacting virus. In order to improve the sequencing capacity, we established the NGS method, which has been actually applied to the genome sequencing of avian influenza viruses in poultry and wild birds, including H6N1 subtype, Mexican-strain H5N2 subtype, HPAI H5Nx subtype, vaccine strains of reverse genetic H5Nx subtype, and those of a variety of subtypes viruses isolated from wild birds. In addition, our laboratory has used NGS in the genome sequencing of lumpy skin disease virus isolated from cattle, bovine viral diarrhea virus isolated from a calf, and Tembusu virus isolated from geese, and these researches have been published in scientific journals. In the future, we will continue to evaluate and establish the third generation sequencing and assist our investigation on other pathogens.

Report on the visitation of Animal and Plant Health Agency and The Pirbright Institute in UK

Yu-Liang Huang

Abstract

For the sustainable development of our livestock industry, our country has spent 24 years on successfully eradicating foot-and-mouth disease and strictly preventing the invasion of African swine fever to protect our local industry. Currently, we are implementing a plan to eradicate classical swine fever, and our institute is also in the process of constructing a high biosecurity laboratory and animal facilities. Therefore, during this visit to the Animal and Plant Health Agency (APHA) and The Pirbright Institute in the UK, we focused on exchanging information regarding the research and diagnosis of foot-and-mouth disease, African swine fever, classical swine fever, and other important swine diseases. During the visit, we engaged with the foot-and-mouth disease and African swine fever research teams at The Pirbright Institute and the classical swine fever research team at APHA, assisting our institute in improving relevant diagnostic methods and initiating academic collaborations on vesicular diseases, African swine fever, and classical swine fever. Additionally, we visited The Pirbright Institute's high biosecurity laboratories and animal facilities to exchange experiences in design and management, which contribute to the construction and management of our institute's high biosecurity laboratories and animal facilities.