Breakthrough in Scientific Research | Jiangxi Bio Pioneers a Synergistic Dual-Enzyme “One-Pot” Method, Leveraging Molecular Mechanisms to Advance the Production of Equine Antiserum Toward Higher Purity and Greater Potency

Recently, Jiangxi Institute of Biological Products Co., Ltd. (hereinafter referred to as “Jiangxi Bio” or… “ Company ” ) is pleased to announce that the research on the production process of therapeutic equine‑derived polyclonal antibodies, jointly conducted by the company’s research team, 5 month 13 It was officially published in the internationally renowned journal “Journal of Chromatography.” B 》（ Journal of Chromatography B ). This study focuses on equine tetanus antitoxin ( TAT ) F(ab') ₂   High-quality process development, for the first time innovatively designed at the molecular level to develop a synergistic dual-enzyme system ( dual-endopeptidase ) a production platform, combined with affinity chromatography, to achieve high purity, high potency, and homogeneity under near-physiological conditions. F(ab') ₂ Fragment preparation offers a more industrially viable solution for the high-quality development of equine‑derived antiserum.

Figure: Company “ Affinity chromatography combined with a dual-enzyme platform ” A groundbreaking research finding was published in the Journal of Chromatography. B 》Journal

To continuously strengthen the company’s technological leadership in antiserum production, building on its existing mature processes, the company’s research team has further focused on equine‑derived products. F(ab') ₂ At the core of the preparation process, we are exploring innovative enzymatic cleavage strategies driven by molecular mechanisms, with the aim of achieving new breakthroughs in product precision, purity, and potency.

Dr. Shen Guangfu, a member of the company’s research team ( Dr. Clifton Kwang-Fu Shen ) stated that this study was conducted using a horse-derived source. IgG Starting from the structural differences and enzymatic cleavage mechanisms of the seven major subtypes, we explore design driven by molecular mechanisms. F(ab′) ₂ A new pathway for the high-quality preparation of fragments. This represents both a continuation and an innovation of existing processes, moving beyond the confines of purely empirical optimization and embracing innovation. Specific targeting of microbial-specific endopeptidases (of Streptococcus zooepidemicus) IdeZ2 Enzymes, of Streptococcus pyogenes IdeS enzyme), establish IdeZ2 + IdeS A dual-enzyme synergistic reaction system, namely “ One-pot method ” Process pathway, leveraging the complementary specificity of dual enzymes to achieve cleavage of horse IgG Comprehensive coverage of subtypes and precise cleavage at the hinge region efficiently convert complex polyclonal substrates into homogeneous products. F(ab') ₂ Product.

Figure: The company’s research team achieves innovative synergy through a dual-enzyme approach. “ One-pot method ” Achieve the horse IgG Precise cutting across all subcategories

Under the experimental conditions established in this study, compared with the conventional pepsin-based process, the synergistic dual-enzyme approach… “ One-pot method ” Combine Protein A The affinity chromatography process has enabled a breakthrough in product purity. 97% , achieving up to 92.2% Protein recovery rate ^[1] 、 77.1% Total titer recovery rate ^[2] Improvement of key production‑capacity indicators is expected. Based on experimental data, the application of this technology is likely to enable more precise and milder reaction conditions, thereby better preserving the antigen‑binding activity and neutralizing potency of the product. This will provide robust support for advancing the manufacturing process of equine antiserum products to a new level, achieving higher purity and enhanced efficacy.

Dr. Shen further stated that this process research has enabled the use of horse-derived… F(ab') ₂ Building on existing technologies, the preparation process has further shifted from an empirically driven approach toward a more scientific and controllable design of molecular mechanisms. Moving forward, the team will continue to focus on scale-up, cost optimization, and validation of the applicability of other equine‑derived antiserum products.

The management of Jiangxi Bio also stated that , this technological innovation represents a breakthrough, marking the company’s transition in the industrial production of antiserums from established processes to “ Design Driven by Molecular Mechanisms ” a “landmark signal” of cutting-edge technological advancement. This breakthrough will not only markedly enhance the high purity, potent efficacy, and stability of existing equine‑derived antiserums, but also inject fresh technological momentum into the company’s efforts to upgrade its technologies, scale up industrial production, and ensure a stable market supply. Moreover, it lays a solid foundation of technical competitiveness, enabling the company to continue leading the global antiserum industry toward high‑quality development.

Capacity Indicator Description: [1] Protein recovery rate: the proportion of the target protein in the source plasma that is successfully retained in the final product after the entire manufacturing process. A higher protein recovery rate indicates greater utilization of the raw material. [2] Total titer recovery rate: the proportion of antitoxin neutralizing activity originally present in the source plasma that is actually retained in the final product after the entire manufacturing process. A higher total titer recovery rate indicates that the antitoxin neutralizing activity of the source material is more fully preserved in the final product.

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About the Journal of Chromatography B 》（ Journal of Chromatography B )

Journal of Chromatography B 》（ Journal of Chromatography B ) is a prominent, influential academic journal in the international field of biomedical analysis, focusing on the development of separation and analytical techniques relevant to biological and biomedical research. It covers innovations in fundamental methodologies and their applications in biological systems, enjoying significant international scholarly impact in the interdisciplinary areas of bioanalytical chemistry, 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 the leading enterprise in China’s antiserum industry and a national high-tech company, with its history dating back to… 1969 The Jiangxi Branch of the Shanghai Institute of Biological Products, established in [year], is one of the few companies worldwide to have achieved full‑chain integration in the production of antiserums. The company adheres to… “ Providing high-quality medicines for people around the world. ” With a strong sense of mission and responsibility, the company has deeply cultivated four core areas—viral infections, bacterial and bacterial toxin‑induced infections, biotoxin poisoning, and autoimmune diseases—aiming to establish a global hub for antiserum products. To date, its products have been exported to markets around the world. 30 In more than [number] countries and regions, we have served over one billion patients worldwide, continuously contributing China’s strength to global public health. For more information, please visit: https://www.jxswzp.cn/ 。