Chuangze Biotech to Showcase China's First Self-Developed Fully Automated Cell Preparation System Compatible with Both Adherent and Suspension Cells
Guidance for Clinical Approval of Cell-Based TherapeuticsCell Preparation IndustryRapid development has led to an increased demand for cell research, development, and manufacturing. Currently, the mainstream method for cell preparation is manual 2D culture, which is highly susceptible to human factors. This approach presents several challenges, including a certain rate of anthropogenic contamination, batch-to-batch variability in culture outcomes, low levels of standardization in manufacturing and regulatory submissions, and difficulties in cost accounting due to operator-dependent variations in the use of reagents and consumables.
ByJinan Chuangze Biopharmaceutical Technology Co., Ltd.(hereinafter referred to as "Chuangze Biologics") independently developed “Fully Automated Cell Preparation System"forShandong Province's FirstAlso suitable forAdherent Cells and Suspension CellsAutomated cell preparation system for culture, featuringHigh-throughput, highly standardized, high-quality, low-cost, low risk of contamination, low error rate, low energy consumption, and multifunctionalsuch features, its fully automated production process for cell therapy products can serve as a model for the Technical Guidelines for Research and Evaluation of Cell Therapy Products (Trial).
On Wednesday, September 4, at 19:30, VCBeat New Product Review Session No. 91 will feature Wan Shouzhao, Sales Director of Chuangze Biotech, who will present “Domestically Developed, Fully Automated Cell Preparation System Compatible with Both Adherent and Suspension Cell Cultures” product promotion.
Fully Automated Cell Preparation System CZ-XBPY-150
Fully Automated Cell Culture System forShandong Province's First, the project was initiated in 2019, integrating biotechnology, automation technology, and IT technology across disciplines; this systemThe core research technology is automated cell culture expansion and manipulation., by developing intelligent robotic systems for high-level laboratories, integrated with micromanipulation, cell manipulation, and cell image processing technologies, to achieve automated handling of adherent cells (such as dermal fibroblasts including true skin and epidermal fibroblasts, mesenchymal stem cells, etc.) andSuspension Cells(Fully automated preparation of NK cells, CAR-T cells, etc.)
Currently, accurate assessment of cell adhesion confluence has been achieved (RMSE < 5%). The system enables prediction of cell density in petri dishes or culture flasks (RMSE < 10%), performs cell morphology analysis in these vessels, and facilitates early prediction of cell fate. Cell culture efficiency has improved by >10%. The single-unit culture capacity exceeds the per-capita output of three cell culture technicians. The precision of self-developed automated module control reaches 0.1 mm, with a low failure rate for devices such as cap-spinning mechanisms under unmonitored conditions.< 1/10,000。
There is an urgent need for stem cell preparation devices in the clinical application of cell therapy at hospitals today., this equipment minimizes manual intervention, effectively prevents contamination and cross-contamination, reduces labor and time costs, operates stably 24/7 to enhance cell yield, provides real-time monitoring of cell growth, enables differential culture, reduces operational errors, and avoids subjective judgment errors. It supports high-quality, integrated stem cell production in compliance with GMP and other medical standards, delivering significant social benefits.
Successful Development of a Fully Automated Stem Cell Subculture System,This marks a new breakthrough in China’s independent research and development of stem cell equipment, improving the situation where China’s high-end life science instruments and equipment relied on imports from Europe and the United States. Its achievements have filled multiple gaps in this field domestically.
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Wan Shouzhao
Sales Director, Chuangze Biotech
Graduated from Shandong First Medical University, with over a decade of dedication to the cell therapy industry. Possesses extensive experience in CGT laboratory establishment, R&D and application of intelligent equipment, and cell culture technologies.
Currently responsible for national sales and investment promotion cooperation regarding automated cell laboratory equipment at Jinan Chuangze Biology.
About Chuangze Biologics
Jinan Chuangze Biopharmaceutical Technology Co., Ltd. was founded in 2016. Against the backdrop of advancements in regenerative medicine, synthetic biology, and cell and gene therapy (CGT), the company focuses on developing intelligent life science solutions and products for automated cell production (upstream and downstream), smart biological laboratories, and automation in laboratory and pharmaceutical/medical device manufacturing. This is achieved by integrating AI technology, automation control technology, foundational electronics development, microscopic optical technology, and biochemical experimental process integration, combined with frontline research on experimental workflows.
The company has established research platforms including a Robotics Automation Laboratory, an Experimental Equipment Testing Laboratory, a Molecular Biology Laboratory, a Cell Biology Laboratory, and an Immunohistochemistry Laboratory. It currently possesses over 40 pieces of hardware and software R&D equipment as well as medical and biological experimental research instruments. The company employs more than 30 staff members, with R&D personnel accounting for 80% of the workforce. Among them are five experts holding doctoral degrees, including one recipient of the National Excellent Young Scientists Fund, one member of the Chinese Academy of Sciences’ “Hundred Talents Program,” and one Taishan Scholar. The company has been honored with titles such as National High-Tech Enterprise, Provincial Gazelle Enterprise, Provincial Specialized and Sophisticated Enterprise, Municipal Specialized and Sophisticated Enterprise, Jinan Engineering Research Center for Intelligent Cell Product Preparation and Biosafety Systems, and Jinan “One Enterprise, One Technology” R&D Center. It holds two Class II Medical Device Certificates, has five marketed products, and is certified under ISO 14001 Environmental Management System, ISO 45001 Occupational Health and Safety Management System, ISO 9001 Quality Management System, and ISO 13485 Medical Devices Quality Management System.
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