Establishment of Analytical Techniques for Evaluating the Efficacy of Monoclonal Antibody Drugs in Animals
Mei-Hsien Chang
Abstract
Monoclonal antibody (mAb) drugs are highly specific therapeutic agents that act on particular antigens through precise antibody-antigen interactions. These drugs have been employed in the treatment of diverse diseases, including cancer, autoimmune disorders, and viral infections. The Muromonab-CD3 (Orthoclone OKT3®) was the first monoclonal antibody drug which had been approved by the U.S. Food and Drug Administration (FDA) for clinical use in humans, then that became available in 1986 as a treatment for acute rejection in kidney transplant patients. Following this milestone, numerous monoclonal antibodies targeting cancers and autoimmune diseases have been introduced, and these therapies have now become integral to treatment options for human diseases. To meet the growing demand for veterinary monoclonal antibody drugs, analytical methods were developed to assess their efficacy in animal applications. These evaluations encompass the determination of quantity, purity, identity, and potency. Quantity was determined by using ultraviolet (UV) spectroscopy, leveraging the characteristic maximum absorbance of proteins near 280 nm. The repeatability of the measurements was evaluated across various concentrations, with relative standard deviation (RSD) values ranging from 1.3% to 5.2%. Purity was assessed by using size-exclusion high-performance liquid chromatography (SE-HPLC), which separates immunoglobulin components based on differences in molecular size and shape. The proportions of aggregates, monomers, and fragments were calculated, and the RSD for repeatability of the reference standard was determined to be 1.92%. The identity and potency of the monoclonal antibody were analyzed by using enzyme-linked immunosorbent assay (ELISA), a technique grounded in the interaction between antigens and antibodies. The calibration curve demonstrated a linear range of 0.78–4.70 ng/mL, with a regression coefficient (R²) of 0.9997. The repeatability of measurements across different concentrations showed RSD values ranging from 0.79% to 6.02%.
Bat coronavirus surveillance in Taiwan, 2022-2024
Shu-Chia HU
Abstract
Coronavirus surveillance project in the Taiwanese bat population has been continuously conducted. In this project, Veterinary Research Institute cooperates with Bat Conservation Society of Taipei and local animal disease inspection authorities to collect bat samples. To monitor and investigate the epidemiology of bat coronaviruses in Taiwan, the collected samples are surveilled via molecular techniques. From 2022 to 2024, 452 bat samples from 16 species were collected across various cities and counties in Taiwan. The predominant species of collected samples were Scotophilus kuhlii (42.9%, 194/452), followed by Pipistrellus abramus (29.6%, 134/452). Coronavirus was detected in five species of bats (S. kuhlii, P. abramus, Eptesicus pachyomus horikawai, Pteropus dasymallus formosus, and P. sp.2 (montanus)). The results showed that the coronavirus detected in S. kuhlii belonged to the subgenus Pedacovirus in the genus Alphacoronavirus; the coronavirus detected in P. abramus, P. sp.2 (montanus) E. p. horikawai belonged to the subgenus Merbecovirus in the genus Betacoronavirus; and the coronavirus detected in P. d. formosus belonged to the subgenus Nobecovirus in the genus Betacoronavirus. Current surveillance results show that no coronaviruses related to human infection have been detected in Taiwanese bat. This project of long-term coronaviruses surveillance is required to understand and early warning of the possible zoonotic diseases among Taiwanese bat population.
Report on “the Laboratory Training on AMR Surveillance in Food Animals”
Nan-Ling Kuan
Abstract
A colleague from Veterinary Research Institute, Taiwan, had participated the regional short-term training program, co-hosted by the World Organization for Animal Health (WOAH) and National Veterinary Assay Laboratory (NVAL) in Tokyo, Japan, lasted from November 11th to November 15th, 2024. Other participants included Philippines, Singapore, Sri Lanka, and Vanuatu trainees. The training aimed to enhance laboratory expertise in standardizing methods for monitoring antimicrobial resistance (AMR) in food animals. Key topics covered included an overview of AMR monitoring system in Japan, fundamental principles of resistance mechanisms, and diverse antimicrobial susceptibility testing techniques (including broth microdilution, disk diffusion, agar dilution, colistin broth disk elution, and PCR detection of AMR genes. The focus was also on applying matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI TOF-MS) and sharing knowledge and experiences in whole genome sequencing and analysis. By engaging in this program, laboratories can bolster their ability to monitor and study antimicrobial resistance while sharing practical insights with international professionals, contributing towards improved expertise and collaborative solutions to tackle AMR-related challenges.