Jiangxi Bio Publishes Research Findings on Key Technologies for High-Purity Tetanus Antitoxin

Help enhance the safety and efficacy of passive immunization medications.

 

Recently, the research team from Jiangxi Institute of Biological Products Co., Ltd. (referred to as “Jiangxi Bio”) published groundbreaking research findings in “Chinese Journal of Biological Products,” a leading Chinese academic journal specializing in biological products. In collaboration with institutions including the School of Medicine at the Southern University of Science and Technology, the team has for the first time developed a specific immunoaffinity chromatography method using a specially designed tetanus neurotoxin subunit (TeNT-Hc-C869A) as a ligand (patent number: ZL 2024 1 1593458.2). This method significantly enhances both the purity and potency of the specific antibody fragment F(ab')₂ present in equine tetanus antitoxin (TAT).

Previously, on April 15, 2025, the research team conducted a systematic analysis and validated the feasibility and innovation of the “specific immunoaffinity chromatography technology, which significantly enhances the safety and efficacy of tetanus treatment,” publishing their findings in the internationally renowned biomedical journal Journal of Chromatography B.

Tetanus is a severe bacterial disease caused by the spores of Clostridium tetani infecting wounds. According to the "Chinese Expert Consensus on Tetanus Immunization and Prevention in Adults," tetanus is highly pathogenic and has a high mortality rate, with an overall global mortality rate ranging from 10% to 30%. Among severe cases, the mortality rate can exceed 50%. According to data from Frost & Sullivan, the global mortality rate from tetanus infections is approximately 41.5%. Tetanus particularly affects regions with poor sanitation conditions and low vaccination coverage. Currently, passive immunization is the preferred and critical treatment approach for providing immediate protection after exposure to infection risk or the onset of clinical symptoms.

Based on the practical need to enhance accessibility and affordability of treatments for patients in developing countries and resource-scarce regions, a research team from Jiangxi Biotechnology has conducted a systematic evaluation of the quality and application potential of specific immunoaffinity chromatography methods. Multiple study results indicate that purifying F(ab')₂ fragments using immunoaffinity chromatography holds promise for improving the specificity of pharmaceutical products, reducing dosage requirements, and enhancing safety in clinical applications.

The study shows that after purification using an immunoaffinity column based on TeNTHc‐C869A, the aggregation of IgG and other impurities in the F(ab')₂ fragment were significantly reduced, increasing the purity to 95.46%. Moreover, its specific activity was markedly improved, reaching 243,902 IU/g—a more than threefold increase compared to the pre-purification level (65,789 IU/g) and far exceeding the national standard.

In addition to significantly boosting the yield of the key protein, this study also evaluated its durability and stability. The results showed that the chromatography column antigen stored at 4°C and 25°C maintained good stability, further confirming the reliability and industrial feasibility of the process.

The Jiangxi biological research team stated that, The specific immunoaffinity chromatography technique has successfully demonstrated its broad applicability in the purification of anti-tetanus antibodies. The developed chromatographic column holds promise for further optimization of the TAT purification process in subsequent studies, significantly enhancing the safety and efficacy of the resulting formulation and laying a solid foundation for research and clinical applications in the prevention and treatment of tetanus. Looking ahead, our company’s team will continue to deepen our scientific research and innovation efforts, consistently providing the biopharmaceutical industry with newer and improved technological insights and practical foundations.

Jiangxi Bio's management also stated that... Improving the purity and efficacy of tetanus antitoxin will have a profound impact on global public health, especially in regions with relatively limited medical resources. This technological breakthrough has enabled the company to achieve a qualitative leap in the field of equine-derived immunoglobulins. Not only does it help enhance the safety and effectiveness of treatments, but it also provides a valuable technical model for the development and industrialization of other equine-derived antibody products in the future. This breakthrough will strengthen the public health emergency drug system, reduce pressure on medical insurance funds, and significantly bolster the capacity of primary-level medical care to provide effective treatment.

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About the Chinese Journal of Biological Products

The Chinese Journal of Biological Products, supervised by the National Center for Disease Control and Prevention and sponsored by the Chinese Society of Preventive Medicine and the Changchun Institute of Biological Products, is a leading domestic academic journal specializing in biological products. It consistently focuses on the cutting edge of biotechnology product research and development, is indexed in important domestic and international databases such as the U.S. Biological Abstracts (BP) and China’s Core Journals of Science and Technology, and has repeatedly been awarded the Ministry of Health’s Outstanding Journal Prize, earning it high academic credibility within the field. For more information, please visit: http://www.zgswj.com.cn 。

About the Journal of Chromatography B

The Journal of Chromatography B is a highly influential, internationally recognized academic journal in the field of biomedical analysis. It focuses on the development of separation and analytical techniques relevant to biological and biomedical research, covering innovations in fundamental methodologies as well as their applications in biological systems. The journal enjoys significant international academic impact in the interdisciplinary area of bioanalysis, separation science, and biomedicine. For more information, please visit: https://www.sciencedirect.com/journal/journal-of-chromatography-b 。

Regarding Jiangxi Institute of Biological Products Co., Ltd.

Jiangxi Institute of Biological Products Co., Ltd. is a leading player in China’s antiserum industry and a national high-tech enterprise. Its origins can be traced back to the Jiangxi Branch of the Shanghai Institute of Biological Products, established by the Ministry of Health in 1969. The company is one of the few global antiserum firms that have achieved full-chain integration across the entire value chain. Upholding the mission of “providing high-quality medicines for people around the world,” the company focuses deeply on four core areas: viral infections, bacterial and bacterial toxin infections, biotoxin poisoning, and autoimmune diseases, thereby building itself into a global hub for antiserum products. To date, the company’s products have been exported to more than 30 countries and regions overseas, serving over one billion patients worldwide and continuously contributing Chinese strength to global public health. For more information, please visit: https://www.jxswzp.cn/ 。