[Innovation-Driven, Win-Win Cooperation]

On December 17, 2023, the training seminar on "Quality Management Standards for Raw Materials Used in the Production of Cell Therapy Products," jointly organized by the Bone Tissue Bank Branch of the China Association of Pharmaceutical Biotechnology and the Regenerative Medicine Professional Committee, concluded successfully. Concurrently, the Fourth China (Shaoxing) Life and Health Industry Conference and the Development Conference of the Entire Industrial Chain of China's Pharmaceutical Biotechnology also came to a successful close.

[Training Seminar on Standards]

As a key participant in the formulation of the standards, CytoNiche has been involved in the development of the standards for 4 and a half years. These standards represent the first set of guidelines in China for the quality management of auxiliary materials used in the production of cell therapy products. The standards were officially released by the China Biotechnology Association on September 14, 2023.

In the training seminar on the standards, Dr. Sun Yanxun, Vice General Manager of CytoNiche and one of the main drafting experts of the standards, delivered an interpretive lecture. As an invited lecturer, he discussed various dimensions of the standards with experts and scholars, including the effective implementation of the standards, trends in related fields, and other topics.

Dr. Sun Yanxun's interpretation primarily focused on Chapter 8 of the standards, titled "Production and Biological Safety," covering elements related to the establishment of quality management systems by raw material producers, challenges faced by quality management systems, content of supplier audits, evaluation and approval processes, classification of changes in raw materials, considerations for changes, change control management, pollution control strategies for external factors during raw material production processes, applicability of containers and closed systems, risk assessment of extractables and leachables (E&L), and quality requirements for preventing contamination of raw materials used in production.

["Extracellular Vesicle Research and Transformation" Workshop]

As an expert in high-quality three-dimensional cell manufacturing, CytoNiche was also invited to attend the conference. Dr. Lan Miaomiao, a senior R&D engineer at CytoNiche, gave a presentation on "Large-Scale MSC Cultivation Facilitating Extracellular Vesicle Large-Scale Production Process" during the "Extracellular Vesicle Research and Transformation" workshop. She shared the latest progress in related research, emphasizing the use of CytoNiche's 3D microcarrier with a bioreactor for large-scale preparation of cell culture supernatant. Additionally, she introduced the 3D FloTrix® vivaEXO extracellular vesicle harvesting system, which enables batch and simultaneous large-scale harvesting of extracellular vesicle products, ensuring the uniformity of vesicle quality. The application of extracellular vesicles harvested using CytoNiche's 3D process has shown significant therapeutic effects in the treatment of pulmonary fibrosis and bone marrow injuries, further highlighting the broad prospects of extracellular vesicles in clinical applications.

[Opening a New Era of Cellular Industrial Development]

As a leading enterprise in the field of three-dimensional cell manufacturing, CytoNiche will continue to release standardized capabilities and research and development transformation capabilities, stimulate industry innovation, and lead the industry's vigorous development. Together with industry partners, CytoNiche is committed to opening a new era of cellular industrial development.

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【CytoNiche】

CytoNiche was established in 2018, led by Professor Yanan Du's research team from the School of Medicine at Tsinghua University, with Tsinghua University as a shareholder. The core technology originated from the transformation of scientific achievements at Tsinghua University and was recognized as a leading technology in "Science and Technology Innovation in China" by the China Association for Science and Technology. As a national-level high-tech enterprise, a national-level specialized and new technology "Little Giant" enterprise, a potential unicorn enterprise, it has also received key research and development special support from the Ministry of Science and Technology.
As an expert in high-quality three-dimensional cell manufacturing, CytoNiche provides a one-stop customized solution for cell scale-up based on 3D microcarriers. The company has built an original 3D cell smart manufacturing platform, achieving large-scale, automated, intelligent, and closed-cell drug and derivative production preparation. This helps global customers establish the most advanced cell drug production lines. After pioneering the production process pipeline for "billion-level" stem cells, the company is accelerating towards "hundred billion-level," dedicating efforts to empower the cell and gene therapy industry with 3D cell scale-up smart manufacturing technology to benefit more patients.