ExCell Bio's Serum-Free T Cell Medium Supports PersonGen's IND Submission for Off-the-Shelf CAR-Vδ1 T Therapy
PersonGen
Developer of Tumor Cell Immunotherapy Technologies and Products
ExCell Bio News
Recently, the clinical trial application for UTAA09 injection developed by Bo Shengji Pharmaceutical Group, a strategic partner of Excell, has been accepted by the National Medical Products Administration. This is reported to be the first off-the-shelf universal UCAR-Vδ1T cell therapy in China to be accepted by the CDE.Excell extends its warm congratulations to its partner on this significant progress and feels greatly honored to have contributed to the advancement of UTAA09 injection by providing serum-free culture medium products and technical services for immune cells in this project.
UTAA09 Injection
UTAA09 Injection is the first universal off-the-shelf CAR-T cell product submitted by Bo Sheng Ji Medicine Science and Technology (Suzhou) Co., LTD. This product is a UCAR-Vδ1T cell therapy derived from healthy donor apheresis as the starting raw material. The UTAA09 Injection, which has now been accepted for review, not only retains its strong tissue and organ homing ability but also ranks among the global leaders in CMC manufacturing processes, achieving significant cost reduction for cell-based drugs. This creates favorable conditions for UTAA09 Injection to potentially expand its indications to autoimmune diseases in the future.
Excell sincerely congratulates Bo sheng ji medicine science and technology (suzhou) co., LTD on its new achievements, and looks forward to more progress in cell therapy drugs, hoping they will be launched soon to benefit patients.Excell's multiple serum-free culture media (T/NK/293/CHO, etc.) have completed the U.S. FDA DMF filing and have assisted multiple clients with FDA/CDE applications, covering multiple technical pipelines such as TCR-T, TIL, γδ-T, CAR-T, UCAR-T, and universal NK cells. This demonstrates that Excell's production processes and quality control systems have reached international standards and regulatory requirements. We will continue to adhere to our mission of "accelerating life science applications and benefiting public health" by providing high-quality and efficient comprehensive product services to global partners, promoting the vigorous development of the biopharmaceutical industry.
Excell Serum-Free Medium
CGT GMP-grade Serum-free Medium Preferred Brand
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Compliance and Stability:
GMP level, FDA filing, supporting from R&D to commercialization, empowering rapid biopharmaceutical submissions.
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International Quality:
Excellent performance, stable quality, self-developed and self-produced, digital factory, annual production capacity reaching tens of millions of liters.
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Multi-category Coverage:
T/NK/293/MSC/CHO/Cryopreservation solutions and other product lines, fully covering the CGT and biopharmaceutical fields.
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Customized Services:
Meet the personalized needs of different projects (formula optimization, packaging customization, etc.) to achieve cost reduction and efficiency improvement.
About Bo Sheng Ji Medicine
Bo Shengji Medicine Science and Technology (Suzhou) Co., Ltd. was registered and established in Suzhou Industrial Park on May 31, 2010. Bo Shengji, or PersonGen, is an abbreviation of Personalized Gene Therapy, symbolizing dedication to the research, development, and innovation of personalized medical technologies. Founded by Dr. Yang Lin and a group of biopharmaceutical experts who have worked for more than a decade in top overseas cancer clinical treatment and research institutions, it is a high-tech enterprise with the primary goal of developing breakthrough tumor cell immunotherapy technologies and products. A wholly-owned subsidiary of the Bo Shengji Group, Bo Shengji Anke Cell Technology Co., Ltd., was registered and established in the High-Tech Zone of Hefei City, Anhui Province, on November 17, 2016. Since its establishment, Bo Shengji Anke has completed hardware construction covering 10,000 square meters, including an internationally top-tier GMP-compliant immune cell preparation workshop, plasmid and lentivirus GMP production and purification workshops, a P2 safety laboratory, as well as advanced quality control and R&D laboratories. It possesses a complete production chain system from plasmids, lentiviruses, to CAR-T cell preparation. Bo Shengji Anke is, to date, the only company in China equipped with a fully automatic, fully enclosed CAR-T cell production line that is complete and internationally leading.
About Excell
ExCell Bio (ExCell Bio) was founded in 2013 with the mission of "accelerating the application of life science and technology to benefit public health." It is committed to resolving bottlenecks in the biopharmaceutical industry and achieving the domestic production of key raw materials. It has now become one of the leading enterprises in China's biopharmaceutical upstream core raw materials sector. The company aims to be a global leader in providing cell-related products and solutions for biopharmaceuticals and life science research.
The company is a national high-tech enterprise, a national specialized and new small giant enterprise, a national intellectual property advantage enterprise, a unicorn cultivation enterprise in the province and Suzhou, the first Chinese member unit of the International Serum Industry Association (ISIA), the Engineering Research Center for CD Serum-Free Culture Medium in the fields of biopharmaceuticals and cell therapy in Jiangsu Province, and a winner of the Suzhou Quality Award.
The company currently focuses on three major product sectors: serum-free media, fetal bovine serum, and identification reagents, providing customers in biopharmaceuticals, cell and gene therapy, biomanufacturing, and basic scientific research with products and services of international quality.
