2024–2025 Report on Biological Product Quality Control Performance and GMP Manufacturing Process Enhancement

Cheng-chu Hsieh

Abstract

Since 1988, our institute has operated an animal pharmaceutical manufacturing facility that complies with Good Manufacturing Practice (GMP) requirements. The Formulation Division is primarily responsible for the research and development, production, stockpiling, supply, and quality management of livestock and poultry vaccines as well as diagnostic reagents. Currently, the institute holds 22 biological product manufacturing licenses. Major products include New Castle Disease Virus H.A Antigen, Pullorum Disease Antigen, Bovine Ephemeral Fever Inactivated Vaccine, Trivalent Inactivated Bacterin Against Riemerella Anatipestifer Infection, and Sheep Pox and Goat Pox Attenuated Live Vaccine, among other important biological products. This report presents a comprehensive analysis of the production batches and quality control testing results of various biological products manufactured between 2024 and 2025. By evaluating manufacturing process consistency, quality trends, and analytical performance data, the report aims to provide a scientific basis for subsequent process optimization and continuous product quality improvement, thereby enhancing the safety, efficacy, and supply quality of the institute’s biological products. In addition, to further improve the quality of veterinary vaccine manufacturing and align with the Ministry of Agriculture’s Veterinary Drug Good Manufacturing Practice (GMP) regulations, as well as international trends in pharmaceutical validation and quality assurance adopted in Europe and North America, the institute is currently implementing a water system upgrade project for its GMP manufacturing building. This initiative is intended to strengthen the stability of process water quality and enhance system validation capabilities, ensuring that the overall production facilities are more fully compliant with current regulatory requirements and international standards. Ultimately, the project is expected to further improve the safety, reliability, and manufacturing efficiency of the veterinary vaccine supply system.

Study on Validation Parameters for Alternative Methods in Veterinary Vaccine Final Product Testing

I-Ting Ko

Abstract

In recent years, international trends have shifted toward utilizing non-animal alternatives for the batch testing of veterinary biologicals. Aligned with the principles of replacing animal testing, Taiwan has also incorporated manufacturer-developed alternative approaches for potency evaluation in certain chapters of the Testing Standards of Veterinary Drugs. To enhance the credibility of these alternative methods for routine batch testing, this study references international guidelines to review and identify the validation parameters required to establish alternative methods for finished product testing fully. These parameters encompass the batch validation of reference standards used in various assays, as well as analytical method validation criteria, including specificity, sensitivity, accuracy, precision, and robustness, as well as an assessment of their practical implementation. For alternative methods used in current animal vaccines (e.g., antigen quantification or relative potency tests), we reviewed the correlation between these alternatives and vaccine efficacy from data submitted by companies to build a background database. Moving forward, we will continue to assist manufacturers in designing alternative potency assessments and validating their proprietary methods, ensuring the effectiveness of in-house finished product controls and their future applicability to national testing standards.