Quality Control Inspection of Biologics During 2022-2024
Cheng-chu Hsieh
Abstract
In 1988, we established a pharmaceutical factory, which complied with the GMP standard requirements at the Veterinary Research Institute (VRI). The main tasks are to produce, to develop, to store and to supply vaccines and diagnostic reagents. VRI currently possesses 21 manufacturing licenses for various biological animal products including Newcastle disease hemaggluutination antigen, pullorum disease antigen, bovine ephemeral fever inactivated vaccine, goat pox attenuated live vaccine, and Riemerella anatipestifer (RA) inactivated trivalent bacterins (serotype 1, 2 and 6), among many others. Analysis of biological product production data from 2022 to 2023, a total of 7 batches were produced in 2022, while in 2023, the number increased to 8 batches. Each batch passed the internal quality control and the national inspection tests, meeting the requirements for domestic epidemic prevention and diagnosis. Furthermore, to enhance the yield of cell culture vaccines, to optimize the production process, and to improve product quality for reserves or emergency vaccine preparation, the area previously used for frozen dried lapinized hog cholera vaccine production went under renovation. This area is being converted into a large-scale cell culture vaccine production zone during 2023 to 2024. The renovation aims to bridge the gap between laboratory research and commercial production by collaborating with industry, government, and academia. This will facilitate the scaling up of cell culture vaccines from experimental production to commercial manufacturing, advancing the development of veterinary pharmaceuticals in our country.
Report on Official Visit Abroad: Improvement of Immersion type Inactivated Streptococcus iniae Vaccine
Tzu-Ming Huang
Abstract
In Taiwan, the annual production value of aquaculture and fishery industries is over $35 billion NTD, and Streptococcus infections cause significant economic losses in the aquaculture industry. The prevention and treatment of streptococcosis can be carried out by several means: antibiotics, which can be used to treat the disease, but have the possibility of inducing the emergence of antimicrobial resistance (AMR) as side effect; vaccines, which can be used to prevent the disease, but the efficacy and cost should be put into consideration; and probiotics, which can be given to improve health and immunity of the fish, but the cost must also be taken into judgment. To prevent and control Streptococcus iniae in fish, the Veterinary Research Institute (VRI) has developed a formalin-inactivated Streptococcus iniae vaccine, which is administrated via intraperitoneal injcction, and can induce adequate immune protection in sea bass and grouper. However, in addition to efficacy, the vaccine administration route and the economic value of the target fish are important issues that affecting the willingness to use such vaccines in aquatic animals. To improve the willingness to use among aquatic animal vaccines, VRI has improved the development of Streptococcus iniae vaccine, and planned to include adjuvant to improve the vaccine, from injection type to immersion immunization. The objectives of this workshop are to learn about the prevention and treatment, and the already established or under development technologies and strategies for infectious diseases from the ARS-USDA experts, and to assist VRI in developing inactivated immersion vaccine for Streptococcus iniae, in order to enhance the capacity of monitoring and research among aquatic animal infectious disease.
The report of participating 27th International Pig Veterinary Society Congress and On-Site Visit in Reference Laboratory of Classical Swine Fever in the University of Veterinary Medicine Hanover
Kuo-Jung Tsai
Abstract
The 27th International Pig Veterinary Society Congress (IPVS) and 15th European Symposium of Porcine Health Management (ESPHM) was held in Leipzig City during June 4th- 7th, 2024. The topics includes pig health, diagnosis and control of swine diseases, pig production and management, food safety and porcine animal welfare. The hot issues of swine diseases included African Swine Fever virus (ASFV)、Porcine Circovirus (PCV), Porcine Reproductive and Respiratory Syndrome (PRRS). By attending 27th IPVS, we could obtain updated knowledge about swine diseases diagnosis and research on control measures via presentations by worldwide swine disease experts, and also publish research results on classical swine fever (CSF) via posters. This not only gains exposure to veterinary research in our country, but also gives the opportunity to exchange study experience with foreign experts. Through the schedule of this conference, we visited Reference Laboratory of Classical Swine Fever in the University of Veterinary Medicine Hanover. Research results were shared between experts and cherish experience of maintaining a high containment facility was learned. This can serve as reference to strengthen biosafety and diagnosis procedures in diagnostic laboratories in Taiwan.