First 2 serum-free culture media association standards were released in China, BioEngine is the project lead and co-author!

On December 1, 2022, Shanghai Biopharmaceutics Industry Association officially released two association standards, "Serum-free Medium Standard for Cell Culture" and "Serum-free Medium Standard for Human Cell and Tissue Culture". The setting of these two association standards is led by Prof. Wensong Tan, Organized and coordinated by the Shanghai Biopharmaceutics Industry Association, and jointly drafted by East China University of Science and Technology and Shanghai BioEngine Sci-Tech Co., Ltd.  Shanghai Municipal Drug Administration, and many culture medium R&D and production enterprises and biopharmaceutical companies in Shanghai also took an active part in the discussion and development of the standards to integrate the opinions from R&D, production, application and government regulation of serum-free culture media.

The above two serum-free medium standards are the first association standards in China, which fill the gap of serum-free medium standards in the domestic biopharmaceutical industry chain. These two standards are scientific, exemplary, and widely applicable. The content of the association standards refers to the U.S. FDA's classification guidelines for serum-free media, the Chinese Pharmacopoeia's requirements for quality control of raw materials and excipients used in the production of biological products, and the technical guidelines for the research and evaluation of cell therapy products regarding raw material control. Based on their decades of work in serum-free medium and extensive research and investigation in the industry,  and taking the current situation and future development needs of serum-free culture media at home and abroad into account, The drafting team put forward normative requirements in many aspects such as raw material control, product quality evaluation and control to serum-free medium development and production enterprises. These two standards provided a clear evaluation standard and basis for the audit and verification of serum-free medium, the key raw material in the upstream process, for Chinese biopharmaceutical enterprises. They also provided a reference for the evaluation and management of the production and quality of serum-free medium by the pharmaceutical regulatory authorities in China. Moreover, it is of great significance to promote the healthy and sustainable development of the Chinese biopharmaceutical industry and improve the international competitiveness of the industry.

Wensong Tan, professor of East China University of Science and Technology and founder of Shanghai BioEngine Sci-Tech Co., Ltd., stated that:

As we all know serum-free medium of animal cells is the key raw material for biological products manufacturing, the design, and manufacture of the serum-free medium have been the weak links in the chain from new drug development to industrialization in China. The domestic standards and production specifications for serum-free medium have been missing for a long time. The high-quality serum-free medium is urgently needed to support and guarantee the healthy and rapid development of China's biopharmaceutical industries such as recombinant protein drugs (including antibody drugs), viral vaccines, and stem cell/cell therapy. The State Key Laboratory of Bioreactor Engineering of East China University of Science and Technology has been engaged in research and teaching of large-scale high-density serum-free culture technology of animal cells for more than 30 years and has rich experience in designing and developing serum-free culture media. BioEngine is the advocate and practitioner of "Intelligent Manufacturing in China" serum-free culture media. Its  Phase I manufacturing site was operated with an international advanced production process and EU Standards. BioEngine built its phase II medium manufacturing base in Shanghai Jinshan Industrial Park in 2021as. This site is a cutting-edge culture medium factory, operated according to GMP regulations, and certified by multiple international quality systems including ISO13485 and MDSAP. It provides the theoretical and practical basis for the development of these two association standards.

The release of these two serum-free medium association standards not only standardizes the production and quality management of domestic medium suppliers but also provides scientific guidance for the localization of serum-free medium. It is critical to break the foreign monopoly, solve the stranglehold of technical problems in the Chinese biopharmaceutical industry, and empower the sustainable development of the biopharmaceutical industry.

The release of these association standards is the first step in establishing the quality management standard for serum-free culture media in China. I believe that in the near future, with joint efforts from the whole biopharmaceutical industry including culture media R&D and production enterprises, the association standards will upgrade to become a more comprehensive industry standard and national standard for "Intelligent Manufacturing in China" serum-free culture media. It will play a supporting and guaranteeing role in the development of Chinese biopharmaceutical industry.

Moving forward, BioEngine will continue to cultivate the field of large-scale animal cell culture technology and practice the "Intelligent Manufacturing in China" serum-free culture medium. We will continue to make breakthroughs and surpass the original intention with craftsmanship, to be the most reliable partner for animal cell culture in the world, and to advance the global biopharmaceutical industry.