System and method for collinearly preparing multi-batch biological products

Abstract

The invention relates to a system and a method for collinearly preparing multi-batch biological products. The system comprises a feed module, a discharge module, an inspection module, a transfer passage, a culture module and a plurality of liquid operating modules, wherein the feed module feeds raw materials and consumables required during preparation; the liquid operating modules separate and sort the raw materials and purify the raw materials before production; the culture module prepares cells; the inspection module detects and checks the prepared cells; the discharge module discharges thecells; the transfer passage transfers the cells among the feed module, the discharge module, the inspection module, the liquid operating modules and the culture module; air pressure control modules are arranged inside the feed module, the discharge module, the inspection module, the transfer passage, the culture module and the plurality of liquid operating modules respectively; the air pressure ofthe transfer passage is higher than those of the liquid operating modules. Through the system and the method, a cross-contamination risk during collinear production of non-finally sterilized biological preparations between different batches is lowered and the production efficiency is improved.

Description

technical field [0001] The present invention relates to a biological product preparation system, more specifically to a system and method for collinear preparation of multiple batches of biological products. 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] For the production process where some cells do not need to be sterilized in the last step, that is, non-terminal sterilized biological product production system, a production line can only produce the same batch of products from the same source at the same time to avoid cross-contamination that leads to a reduction in the production success rate Problems occur, but because the time required for different processes in the production process is different and most of them are...

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Problems solved by technology

[0003] For the production process where some cells do not need to be sterilized in the last step, that is, non-terminal sterilized biological product production system, a production line can only produce the same batch of products from the same source at the same time to avoid cross-contamination that leads to a reduction in the production success rate The problem occurs, but because the time required for different processes in the production process is different and most of them are carried out sequentially, this has caused a large number of idle equipment, which seriously affects the efficiency of the production of non-terminal sterilized biological products

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