Developing the Safety Assessment and Risk Management Techniques of Genetically Modified Animal Biologics
To accomplish the management of genetically modified (GM) animal biologics, the establishment of safety assessment techniques is urgent. Moreover, strengthening international information collection can ensure that inspection technology is consistent with international standards. In this study, we collected European and American regulations of safety assessment of GM animal biologics and inventoried the documents and tests of the live GM animal biologics reviewed in recent years to identify the inspection technical gap. According to the results of the inventory, we established the safety assessment models such as the tissue tropism test, the transmission route test, virulence regression in vivo / in vitro test, and environmental survival/spread test. Furthermore, we also set up basic test technologies and trained technical staff in the team by standard procedure establishment and education. We can effectively fill the current risk assessment technology gap of GM animal biologics, and enhance the international competitiveness of biopharmaceutical industries for veterinary GM products in our country. The related research achievements can also be used as references when authorities elaborate on regulations.
Evolution of AHRI Hog Cholera Vaccine Manufacturing
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 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. Hog cholera vaccine made by AHRI has changed from crystal violet vaccine to lapinized vaccine, and then evolved into tissue- cultured vaccine. As concerns of animal welfare, the live lapinized hog cholera vaccine has no longer been produced by the AHRI since 2022.