EurekaBio, as a leading upstream supplier in the CGT field, has been focused on the research and development of core technologies and processes, providing high-quality products, technology, and services for biopharmaceutical companies. In recent years, EurekaBio’s independently developed CellSep™ PRO fully closed automated cell processing system (hereinafter referred to as CellSep™). In recent years, EurekaBio’s independently developed CellSep™ has gained widespread adoption in the research and development of cell therapy products, successfully assisting nearly 30 domestic CGT companies in filing their IND applications.
With the launch of CAR-T drugs in China, the country’s CGT industry has entered a crucial stage of commercial development. However, there are still two major “challenges” that need to be addressed in the journey towards commercialization. The first challenge relates to the high cost and lengthy supply cycle of imported equipment, and the second challenge involves the immaturity and inadequacy of production processes and quality control technologies for CGT products. Overcoming these two major “challenges” can effectively help reduce costs and increase efficiency in the CGT industry, accelerate successful IND applications, and promote the commercialization process of CGT products.
To address these two major “challenges”, it is crucial to have domestically produced core process equipment that is fully closed, automated, disposable, digital, and compliant with the GMP standards. In response to the industry’s pain points and emerging trends, EurekaBio has independently developed the CellSep™ PRO.
The CellSep™ PRO, launched in 2020, has successfully broken the market monopoly of similar imported equipment. Through continuous product optimization, EurekaBio has independently addressed various technical difficulties, accumulating a wealth of successful customer cases and application experience. The stability of the equipment and associated consumables has been extensively verified over a significant period, providing comprehensive support for the research, production, and commercialization of CGT products.
Among EurekaBio’s CGT customers, 10 companies have already incorporated the CellSep™ PRO in Phase I, Phase II, and Phase III clinical trials. Additionally, nearly 20 companies have incorporated the CellSep™ PRO into Phase IIT or are preparing or undergoing IND applications, with the potential to obtain IND approval in the near future. The CGT companies and R&D pipelines served by EurekaBio encompass a wide range of cell therapy product types, including autologous CAR-T, allogeneic CAR-T, TCR-T, CAR-NK, TIL, MSC, and other cellular therapies. With its significant potential, the CellSep™ PRO is poised to become the first domestically produced cell processing equipment, contributing to the commercialization and market entry of cellular therapies.
The CellSep™ PRO is a versatile, fully automated, and closed cell processing equipment that can perform multiple standard processes for cell preparation, including PBMC separation, beads incubation, lentiviral vector centrifugation transduction, post-culture enriching & washing, cell washing & dispensing, etc. Additionally, it offers customization and optimization options tailored to to different sample types and experimental requirements. This flexibility effectively assists pharmaceutical companies throughout the research and development to clinical stages, making the CellSep™ PRO an indispensable tool for the research, process development, and production of cellular therapies.
Quality assurance – The CellSep™ PRO’s fully closed system and automated control can reduce contamination risks caused by human error, minimize inter-batch variability, and enhance product stability. This can facilitate rapid approval from regulatory agencies and provide strong support for the development of innovative drugs.
Traceability – During the IND application process, it is necessary to establish a strict document management system to ensure that the entire production and process records are traceable. Upon completion of the CellSep™ PRO process, the system automatically generates a PDF report containing vital information such as raw materials, equipment, process parameters, and operators. This traceable data serves as an important support for drug approval procedures.
Industrialization implementation – The CellSep™ PRO ensures process stability and reproducibility through automated procedures, which can be customized and applied to different types of cells and cell processing. It facilitates the transition from the R&D stage to the IND application, meets GMP production requirements, and achieves swift industrialization implementation through parallel amplification.
Through years of optimization and accumulation, EurekaBio’s independently developed CellSep™ PRO has earned recognition and praise from numerous customers. Currently, the CellSep™ PRO is capable of meeting customers’ customized requirements, offering advantages such as high process stability and user-friendly operations. It serves as the optimal partner for CGT product preparation, saving costs and time.
Building upon the wealth of experience and a deep understanding of market demand, EurekaBio recently launched the CellSep™ MAX, a fully closed automated continuous flow cell processing system. This system can be used for concentration, washing, preparation, and dispensing of large volumes of cell supernatant. Meanwhile, EurekaBio has launched other equipment including sterile tubing welders, heat sealers, and wave reactors, providing end-to-end integrated solutions for the preparation and production of CGTs.
With a steadfast commitment to the mission of “Empowering CGT and Solving the Most Challenges in the Industry”, EurekaBio remains focused on addressing the core challenges of CGT. Through the provision of high-quality CGT products and technical services, EurekaBio actively supports IND applications and promotes the industrialization and commercialization of CGT products.
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