Development of Safety Assessment and Risk Management Techniques for Genetically Modified Animal Biologics
In order to effectively manage genetically modified (GM) animal biologics, the establishment of safety assessment techniques is urgent. Moreover, strengthening international guidelines collection can ensure that inspection technology is consistent with international standards. In order to identify the gaps in effective technical inspections, we completed the collection of European Union and United States standards for the safety assessment of GM animal biologics and inventoried the recently reviewed documents and tests of these GM animal biologics. According to the results of the inventory, we established several safety assessment models including those that evaluate tissue tropism, transmission routes, virulence regression in vivo/in vitro, as well as environmental survival and spread. Furthermore, we also set up standard analytical techniques while also training technical staff in standard operating procedures. We have effectively used risk assessment to identify and address the current gaps in effective technological monitoring of GM animal biologics, and this will enhance the international competitiveness of the domestic biopharmaceutical industry involved in the production of veterinary GM products. The related research achievements can also be used as references when authorities draft future regulations.
Development of a Hog Cholera Vaccine at AHRI
Hog cholera, also known as classical swine fever (CSF), is caused by the classical swine fever virus (CSFV), and it is a highly contagious and lethal disease affecting swine. Clinical outcomes of CSFV infection vary with different virus strains, from the acute form, which results in mortality, to other strains resulting in mild, chronic or even inconspicuous symptoms. CSFV is a RNA virus belonging to the genus Pestivirus of the family Flaviviridae, which commonly induces fever, diarrhea and internal hemorrhage in infected hosts. The standard hog cholera vaccine produced by AHRI has gone through several advancements, from a crystal violet vaccine to a lapinized vaccine, and now to a tissue- cultured vaccine. Due to animal welfare concerns, the lapinized hog cholera vaccine is no longer produced by the AHRI starting in 2022.