Modular automatic cell culture system and method

Abstract

The invention relates to a modular automatic cell culture system and method. The system comprises a cell preparation unit, a cell manufacturing unit, a quality detection unit and a cell cryopreservation unit, the cell preparation unit is used for separating and sorting target cells and purifying the target cells before production; the cell manufacturing unit is used for manufacturing cells and carrying out daily production quality detection; the quality detection unit is used for complete detection of the manufactured cells before patient reinjection; and the cell cryopreservation unit is usedfor short-term or long-term cryopreservation of cells. According to the invention, cell preparation, manufacturing, quality detection and cell cryopreservation are divided into modules, are integrated to form a structure and are connected through a standard connection expansion interface; and data recording and daily operation planning and management of the units are carried out by utilizing a server, so that the cell culture process is modularized, the facility construction cost is reduced, cells are automatically cultured, and effective cost optimization, industrial scale expansion and economic benefits which are brought by large-scale cell production are realized.

Description

technical field [0001] The invention relates to a cell culture method, more specifically to a modularized cell automatic culture system and method. Background technique [0002] The clinical efficacy of cell therapy has been verified, domestic and foreign policies strongly support the development of related industries, and the industry is ushering in the development trend, which puts forward a huge demand for large-scale cell preparation. [0003] At this stage, cell preparation at home and abroad is still mainly manual production. When expanding production capacity on a large scale, a large number of personnel costs, a large number of personnel training costs, large-area high-cleanliness facility construction costs, and high certification costs for new facilities, etc., make Industrial investment is unaffordable. At the same time, the quality instability and inhomogeneity brought about by manual preparation make it difficult to meet the high quality and safety requirements ...

AI Technical Summary

Problems solved by technology

[0003] At this stage, cell preparation at home and abroad is still mainly manual production. When expanding production capacity on a large scale, a large number of personnel costs, a large number of personnel training costs, large-area high-cleanliness facility construction costs, and high certification costs for new facilities, etc., make Industrial investment is unaffordable. At the same time, the quality instability and inhomogeneity brought about by manual preparation make it difficult to meet the high quality and safety requirements of cell therapy.

Manually operated semi-automated equipment can only produce and prepare for a single patient at the same time. In order to realize the scale of industrialized cell production and effectively reduce the cost of preparation and production, the benefits brought are limited and the cost of use is high. Existing semi-automated equipment is usually customized based on specific production processes Research and development, it is difficult to meet the adaptability and scalability requirements of different cell therapy programs and different production processes, and the quality and quality control of large-scale production in the later stage. It is difficult for existing semi-automated equipment to provide systematic production and quality control data, although in terms of production efficiency It has been improved, but the existing semi-automatic equipment still requires a lot of manual operation, and still requires the construction of a high-level purification room environment. In addition, before the cells are prepared for large-scale production, it is necessary to separate, sort, clean and purify the target cells After the cell preparation is completed and at important nodes in the production process, it is necessary to carry out sample retention and release testing of the cell product. Before the cell product is injected back into the patient's body, it is necessary to observe and plan the injection window. Frozen storage, based on the existing production and business model, the relevant steps are distributed in different places. The operation process requires a large number of special plant facilities and personnel training, and the operation and transshipment during production, inspection, and storage bring products Pollution and quality fluctuations, as well as the extension of the delivery cycle of the final product, for the regulatory authorities, the quality control of the whole process is more difficult. Once a quality or safety accident occurs, it is difficult to efficiently and accurately locate the cause of the accident, and the cycle is longer and more difficult. Effective cost optimization, industrial scale expansion and economic benefits brought about by large-scale cell production

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