Vice President Song Xiaodong of Hrain Attends 2018 Next-Generation CAR & TCR-T S
On November, 24, Next-generation CAR&TCR-T Seminar hosted by Bioon 2018 (the 4th Session) was held in Pudong, Shanghai. Well-known experts, scholars and clinicians at home and abroad have been present in the seminar and discussed the future development of CAR-T cell immunotherapy. Vice President Song Xiaodong of Hrain Biotechnology Co., Ltd. (hereinafter referred to as Hrain) attended the seminar upon invitation, delivered a speech titled “Pharmaceutically Technical Requirements for Clinical Declaration of CAR-T Cells in the United States”, and chaired a saloon themed “Automated Cell Culture”. His speech was warmly welcomed by the audience, and played a positive role in the clinical application of cell immunotherapy technology and standardized treatment.
On the morning of November 24, Vice President Song Xiaodong of Hrain delivered a report themed “Pharmaceutically Technical Requirements for Clinical Declaration of CAR-T Cells in the United States”. Mr. Song, with years of experience in foreign registration laws and regulations, interpreted the latest cell therapy policies to ensure that cell therapy enterprises have rules to follow. He also elaborated on relevant background, administration information, pharmaceutical summary, BPC and preparations as well as the pharmaceutically technical requirements for clinical declaration of CAR-T cells in the US and relevant regulatory documents. For years, Mr. Song has been active in activities related to Chinese drug supervision and regulatory registration, been working with NMPA and various industry associations to promote the improvement and development of regulations for China’s pharmaceutical industry, and played a positive role in standardizing CAR-T.
On the afternoon of November 24, Mr. Song chaired the saloon themed “Automated Cell Culture”, and expounded on “Quality by Design (QbD)” with a speech titled “QbD and CAR-T Production”. According to his speech, QbD is a concept where a research is built on preset product profile; by the sound knowledge of key quality attributes, reliable trial design, and detailed study on critical material, process parameters are defined. In spite of the interaction of multiple factors, a Design Space could be provided for ensuring good product performance and stable process; based on the Design Space, quality risk management, quality control strategies and drug quality system will be established.
The advanced idea of “applying QbD in CAR-T production” proposed by Mr. Song was warmly welcomed and discussed by participants, leading the meeting into a high tide.
According to relevant statistics, China is second only to the US in terms of applying for cell therapy clinical trials around the world. Hrain is a rising force with fruitful outcomes in the field of cell immunotherapy. Recently, Hrain’s CD19 was approved for clinical trials, China’s first clinical trial of new CAR-T drug, which enrolled the first patient and completed collection at Zhongshan Hospital affiliated to Fudan University. For Hrain, this is just a start, and there is still a long way ahead for CAR-T development in China. We hope that the cell immunotherapy will be increasingly standardized and aligned with international standards. This requires the common work of all the researchers. This meeting is of profound importance to the joint endeavor to promote the development and open up new prospects for cell immunotherapy, as it serves as a gathering of authoritative experts and scholars within the industry to have face-to-face exchange of views, solve doubts and standardize regulations.