The "2nd China Plasma Protein Industry Development Conference" was held in Chengdu, Sichuan from November 07 to 09, 2025. Themed "Plasma Protein Drugs: Enhancing Independent Innovation Capabilities and Upgrading Industrial Development Level", this conference was hosted by the China Biochemical Pharmaceutical Industry Association and organized by the Institute of Blood Transfusion of the Chinese Academy of Medical Sciences and the Plasma Protein Branch of the Association. It brought together industry authorities such as Academician Ma Guanghui, representatives from regulatory authorities, and enterprises across the entire industrial chain to create a high-end communication platform covering technological innovation, standard setting, and international compliance. As a co-organizer, Grand Shuyang Life Sciences (Chengdu) Co., Ltd. was deeply involved in this industry event.

Unified Standards Lay a Strong Foundation for Industry Quality

During the conference, the launch meeting for the association standard,Technical Guidelinesfor Viral Marker Testing in Pooled Plasma, was held concurrently. To address the industry's challenges of inconsistent pooled plasma testing methods and limited data comparability, this standard was led by the China Biochemical Pharmaceutical Industry Association, with Grand Shuyang as a key contributor, and jointly drafted alongside the Institute of Blood Transfusion of the Chinese Academy of Medical Sciences and several leading blood product manufacturers. The standard will integrate Grand Shuyang's practical experience in source plasma testing by optimizing the viral marker detection process, defining critical parameter thresholds, and establishing a data traceability system. This will enable ensure consistent and comparable test results of test results "across enterprises and production batches", providing a unified technical foundation for quality control of source plasma in the industry.

Industry research indicates that unified pooled plasma testing standards can significantly reduce production risks caused by testing discrepancies, while also providing essential technical support for the international registration of plasma protein drugs. Wei Yongchen, Quality Director of Grand Shuyang, stated that "As a blood product manufacturer, we fully understand that 'standards first' is the foundation for the industry's high-quality development. Participating in drafting this standard is not only our responsibility to transform corporate practices into industry assets but also a vital step toward aligning China's plasma protein detection technology with international standards".

Technological Empowerment Drives Compliance Management Advancement

Wei Yongchen, Quality Director of Grand Shuyang, presented the company's latest practical achievements in international compliance under the theme International Compliance Orientation: Practical Innovations and Strategic Approaches in Blood Product Validation Management. In response to the industry's core pain points of "difficulty in implementing international standards and low validation efficiency", the company has innovatively built a "data-driven + full-process coverage" validation management system. Through real-time collection of 2100 key data points in the production process, combined with AI-assisted validation, the blood product validation cycle is shortened by 20%. For international regulatory requirements such as those of the Food and Drug Administration (FDA) and European Medicines Agency (EMA), a full-chain solution of "standard interpretation, process alignment, and risk control" has been formed, helping the company's three core products pass international certification inspections.

The report also unveiled the first application case of Grand Shuyang's "Validation Management Digital Platform". This platform integrates multi-dimensional data from production, quality, and R&D, enabling real-time generation of validation reports that comply with international standards. It effectively addresses the challenges of data fragmentation and traceability difficulties in traditional validation processes, driving the shift from "manual-driven" to "intelligence-driven" validation management, and offering a replicable technical solution to support the industry's international compliance efforts.

Ecological Collaboration Shapes the Blueprint for Industrial Development

Shuyang has devoted over 40 years to deep industry commitment, consistently upholding three core responsibilities: First, guided by the principle of "One Dose, Two Lives", it fortifies a comprehensive safety barrier across the entire supply chain to provide patients with efficient and accessible medical solutions; second, it advances industry collaboration by integrating testing expertise into association standards and sharing the "AI + Compliance" digital platform to help break through international barriers; third, it embraces openness and mutual benefit by strengthening international cooperation and fostering healthy competition within the industry, jointly building a sustainable industrial ecosystem.

Blood products are vital to public health and safety, and their high-quality development depends on the collaborative efforts across the entire industry chain. Moving forward, Grand Shuyang will continue to deepen its collaboration with the China Biochemical Pharmaceutical Industry Association, research institutions, and industry peers. It will both accelerate innovation and implementation in quality management and digital technologies, and work together to explore a new industry ecosystem model based on "technology sharing, joint risk prevention, and shared success". Through these efforts, Grand Shuyang aims to empower China's plasma protein industry with enhanced international competitiveness and contribute to protecting public health.