2017 was the inaugural year of CAR-T cell therapy,NovartisThe success of Gilead’s Kite has sparked a global wave in the research and development of immunotherapy drugs. In the process of translating research achievements into practical applications, the demand for standardization and scalability in commercial manufacturing has gradually become prominent.
The most prominent challenges in the large-scale manufacturing of CAR-T cell therapies include:
(1) Operation in a sterile, closed system
(2) Robust and streamlined workflow
(3) Flexible and Scalable Solutions
(4) Application Models of Digitalization and Automation
(5) Comprehensive Drug Monitoring and Risk Early Warning
(6) Strictly adhere to current Good Manufacturing Practices (GMP) and regulatory guidelines
On October 9, 2018, Shanghai UniCAR-Therapy Biomed-Phamaceutical Technology Co., Ltd. (UniCAR) (hereinafter referred to as “UniCAR”) announced a collaboration with Terumo BCT, selecting its Quantum® Cell Expansion System to jointly advance the automation of CAR-T cell therapy manufacturing processes. The two parties also planned to establish a Terumo BCT Technology Center in Shanghai this November. UniCAR’s various CAR-T cell therapy technologies are designed to reduce treatment-related side effects and improve patient outcomes.
As a global provider of comprehensive solutions in blood components, therapeutic apheresis, and cell technologies, Terumo BCT is committed to delivering flexible solutions for the development of CAR-T cell therapies. Compared with traditional manual cell expansion methods, Terumo BCT’s Quantum system operates within a closed-cell culture environment, thereby reducing the risk of open-system contamination, improving the quality of both expanded cells and viral vectors, and shortening expansion time. Furthermore, the Quantum system incorporates multiple predefined tasks, offering greater protocol flexibility to accommodate diverse manufacturing requirements.
This collaboration between UNICAR-THERAPY and Terumo BCT clearly demonstrates UNICAR-THERAPY’s commitment and determination to advancing the clinical translation of cell therapy outcomes.
Gene TherapyA pioneer in the field, Dr. Yu Lei, CEO of UNICAR-THERAPY, stated, “It is only by sharing best practices and showcasing innovative technologies that drive the industry’s robust growth that we can make wise decisions.”
UNICAR-THERAPY was established in February 2015, focusing on the development of CAR-T technologies and products. By collaborating with Carl June’s team at the University of Pennsylvania and clinical research centers in the hematology departments of multiple renowned large tertiary hospitals in China, UNICAR-THERAPY ensures that its CAR-T technology remains at the forefront globally, while maintaining product standardization and quality. Currently, it has completed hematologic
TumorCAR-T clinical study cases have exceeded 400, and have reached international standards.
Clinical Trialexpected efficacy consistent with that reported in
Since 2018, Unicarth (Shanghai Unicar-Therapy Biomed-Pharmaceutical Technology Co., Ltd.) has submitted and is preparing to submit multiple chimeric antigen receptor T-cell (CAR-T) candidate drugs to the National Medical Products Administration (NMPA) of China in the form of Investigational New Drug (IND) applications.
Clinical TrialsApplication. In addition, SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD has also advanced CAR-T 2.0 technology, which aims to reduce treatment side effects and improve patient efficacy.
Next, UNICAR-THERAPY will integrate
Big Data, artificial intelligence and the Internet of Things, in blood
Tumorand spare no effort in increasing investment in cellular immunotherapy for solid tumors, truly implementing precision medicine, striving to become a domestic leader in the field of cellular immunotherapy in the coming years, and acting in response to patients' urgent needs. (
BioonBioon.com)
References:
https://globenewswire.com/news-release/2018/10/10/1618932/0/en/UniCAR-Therapy-and-Terumo-BCT-Collaborate-to-Advance-CAR-T-Cell-Therapies-and-Create-a-Shanghai-China-Center-of-Excellence.html