Quality control of immune cell storage

With the development of life science, cell therapy has gradually removed its mysterious veil and come to the stage to be reviewed and evaluated by the public. In this process, there are extensive research by R&D personnel, process exploration by preparators, and more importantly, exploration by quality personnel on the risk and quality control of the whole cell life cycle.

This paper takes immune storage as an example to share with you the quality control of immune cell storage.

1. Collection and transportation control
In order to ensure the quality of the samples, the quality control personnel will screen the samples for 5 viruses before collection, and those who pass the screening can be allowed to formally collect. Collection is performed by qualified professionals using certified sterile medical device products. After the collection is completed, the collection personnel will post barcode, one code for each person, which can be traced to the source and prevent confusion.

The collected samples are put into a special sample transfer box for transportation, and the whole process of transportation is temperature controlled. After the samples arrive at the laboratory, the temperature measurement, sample weighing and information verification should be carried out, and the preliminary rapid virus detection should be carried out after the verification. After passing the rapid test, it enters the preparation stage.

2. Separation and preparation control
The preparation process was carried out in a clean laboratory in accordance with the design Standard of Clean Workshop for Pharmaceutical Industry GB50457-2019 and the relevant requirements of Pharmaceutical Manufacturing Quality Management Practice (GMP). Suspended particles, settling bacteria and plankton in the clean laboratory are monitored regularly according to the national standards.

Before, during and after the preparation, the quality control personnel will test the cell number, viability and cell morphology of the samples, and the final product quality control personnel will conduct sterility check, mycoplasma, endotoxin and other safe tests. At the same time, a small number of samples will be retained for quality tracking and comparison.

All processes of preparation and testing are carried out in accordance with the standard operating procedures that have been controlled. Personnel receive 2-3 months of professional knowledge and biosafety training before working to ensure that their skills can meet the post requirements. Materials are purchased from qualified suppliers after evaluation, and can only be used after the arrival inspection. Periodic maintenance plan is made for instruments and equipment. Spare instruments are available for key equipment to ensure that samples can be prepared and tested smoothly at the first time when they arrive at the laboratory.

3. Stored procedure control
After the samples are tested and qualified, they enter the freezing storage link, in which the temperature is controlled by the programmed temperature reducer throughout the whole process. After strict verification, the cooling curve can ensure that the cells can maintain good cell activity after cell recovery.

After cooling, transfer to temporary storage area, and release into storage only after all test results are issued. The formal tube adopts automatic gas-phase liquid nitrogen storage system which can automatically replenish liquid nitrogen to ensure the stability of storage temperature.

4. Test item control
The detection methods of all test items are regularly compared and validated. For example, for complete blood count, the quality control personnel will not only carry out the quality control test every day, but also invite the manufacturer to come to the factory every year for the annual instrument calibration and maintenance. In addition, the quality control department staff will participate in the national quality assessment activities every year to confirm the accuracy of the quality control personnel's test results through quality assessment and testing.

To sum up, the quality control of immune cell storage is an organic whole involving people, machines, materials, methods, rings and measurements, which needs sufficient funds and a certain number of professionals as support. In the future, the company will continue to increase the investment and support in quality control to ensure the safety and effectiveness of every cell stored.