Recently, the production line for the fourth-generation human immunoglobulin for intravenous injection of Grand Shuyang Life Sciences (Chengdu) Co., Ltd. was officially commissioned. The project is designed according to EU GMP standards, with an annual plasma feeding capacity of 3000 tons, positioning it as a leading large-scale production line with advanced technology for the human immunoglobulin for intravenous injection. The new production line achieves groundbreaking enhancements in impurity control, clinical safety, and production efficiency through core process upgrades such as chromatography purification and nano-scale virus filtration, providing improved treatment options for patients with immunodeficiency and autoimmune diseases.

Technological Breakthrough: Defining a New Standard for Human Immunoglobulin for Intravenous Injection

The newly constructed production line for the fourth-generation human immunoglobulin for intravenous injection utilizes the "three-step chromatography purification technology", developed with Grand Shuyang's fully independent intellectual property rights. Through the precise combination of low-temperature ethanol precipitation, caprylic acid treatment, ion exchange chromatography, and affinity chromatography, IgG purity is increased to over 99%. Notably, this process reduces residual coagulation factor XIa to below 1 mIU/mL, significantly decreasing the thrombotic risk compared with conventional products and offering a safer therapeutic option for patients with cardiovascular and cerebrovascular diseases.

To ensure product safety, an innovative 20-nanometer viral filtration system has been implemented, effectively intercepting a range of pathogens, including parvovirus B19. Combined with an independently developed high-temperature, low-pH viral inactivation process, this method significantly shortens the overall production cycle while balancing efficiency and product safety.

Production Capacity and Social Benefits

The production line focuses on "scalability + lean" principles to achieve a significant leap in human immunoglobulin production capacity:

Leading Scale: Single-batch processing of 12 tons of plasma components enhances antibody spectrum integrity by 30%, ensuring high titers of therapeutic antibodies;

Cycle Shortening: The high-temperature accelerated low-pH inactivation technology reduces the plasma-to-bulk production cycle time by 80% compared with industry averages;

Green Manufacturing: The automated enclosed system minimizes human intervention while ensuring compliance with the WS/T 786-2021 standards in critical processes.

Inheritance and Innovation: Forty Years of Perseverance

August 2025 marks the significant 40^th anniversary of Grand Shuyang. From its origins in 1985 at a military blood donation station, to joining the Grand Life Sciences Group in 2001, and the establishment of Asia's largest single-site intelligent manufacturing center for blood products., Grand Shuyang has consistently upheld the original mission of pharmaceutical enterprises with the principle of "one dose, two lives". It has always treated clinical needs as the starting point and focal point of technological innovation. For 40 years, driven by the vision of becoming an "international high-quality service provider across the entire blood product chain", Grand Shuyang has consistently innovated in areas such as plasma collection, R&D, quality control, and marketing, establishing itself as a benchmark enterprise in China's blood products industry. The newly constructed production line for the fourth-generation human immunoglobulin for intravenous injection signifies a historic leap in China's blood product manufacturing process, advancing from imitation-driven innovation to a position of leadership in innovation.