CelluPro Leads Development of New Group Standard for Serum-Free Mammalian Cell Culture Medium

June 1, 2025 – The group standard for Serum-Free Mammalian Cell Culture Medium (Standard No.: T/CSBME 086-2025), drafted under the leadership of Yantai CelluPro Biological Technology Co., Ltd., was officially released. The standard was issued by the Chinese Society of Biomedical Engineering (CSBME) and has been published on the National Group Standard Information Platform. has been publicly listed on the National Group Standards Information Platform.

Image: Announcement on the National Group Standards Information Platform

The release of this standard marks a significant milestone in the development of China's serum-free cell culture media industry. It provides key technical specifications for sectors such as biopharmaceuticals and cell therapy, signaling an important step toward greater standardization and regulatory alignment in China’s serum-free mammalian cell culture media sector.

Serum-free media are essential raw materials for mammalian cell culture and are widely used in the production of monoclonal antibodies, recombinant proteins, viral vectors, and cell therapy products. Compared to traditional serum-containing media, serum-free media offer advantages such as defined composition, high batch-to-batch consistency, and reduced risk of animal-derived contamination—making them a critical enabler of innovation and advancement in the biopharmaceutical industry.

This newly released group standard was authored by Yantai CelluPro Biological Technology Co., Ltd., with contributions from several institutions, including Tongji University, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., Tasly Pharmaceutical Group Co., Ltd., Suzhou Youyi Biotechnology Co., Ltd., RemeGen Co., Ltd., and MabPlex International, Ltd. The project was initiated in July 2024 and underwent multiple rounds of expert review, including project evaluation, technical review, and final approval, before its official release. The standard systematically defines the physicochemical indicators, performance requirements, quality control, and testing methods for serum-free mammalian cell culture media, providing a unified technical evaluation framework for the industry.

Industry Impact and Significance

The implementation of the Serum-Free Mammalian Cell Culture Medium group standard is expected to:

● Guide media manufacturers in standardizing technical approaches, enhancing product competitiveness, and supporting greater localization and supply chain resilience;

● Provide biopharmaceutical companies with a basis for media selection, reducing R&D and production costs while ensuring stability in cell culture processes;

● Offer a reference standard for industry regulatory oversight, supporting the improvement of safety evaluation systems for biological products, and potentially paving the way for future industry and national standards.

The adoption of this standard will help address long-standing issues in the serum-free mammalian cell culture media market, such as inconsistent quality and the lack of unified evaluation criteria, thereby strengthening supply security and technological independence in critical upstream biopharmaceutical materials.

Future Outlook

With the rapid growth of cell and gene therapy (CGT), mRNA vaccines, and other emerging fields, the demand for serum-free mammalian cell culture media is expected to continue rising. Moving forward, the standard working group plans to promote international standardization efforts and initiate future revisions and updates to address emerging applications such as dynamic cell culture and customized media formulations.