I. General principles of design

The preparation of stem cell preparations should follow the basic principles of good manufacturing practices (GMP)

Second, functional zoning.

1. Receiving, sampling and distribution area: it should be isolated from the preparation area and have an independent clean environment, and the sampling operation at the time of receiving should be Class A clean.

In the big environment.

2. Preparation production area: set up special and independent preparation area, preparation facilities and equipment. Cell manipulation (such as separation, culture, filling, etc. ) The operation of reagents and instruments that are not completely sealed and are in direct contact with cells and cannot be sterilized at the terminal should be carried out in Class A environment under Class B background.

Preparation of reagents, isolation, amplification and induced differentiation of stem cells, preparation and filling or sub-packaging of stem cell preparations should be carried out in clean areas in different regions.

3. Quality control area: the preparation area is physically isolated, and the administrative area, living area and auxiliary area should not interfere with the preparation of stem cell preparations.

The components of stem cells should meet the quality requirements of current China Pharmacopoeia.

At different stages of the process (including cell bank), stem cells should formulate corresponding process control items and quality standards, including sterility, mycoplasma, exogenous and exogenous viruses, cell identification, cell viability and growth characteristics, cell purity and uniformity, nuclear type, biological efficacy, specific indicators of clinical indications, abnormal immune response, endotoxin and tumorigenicity.

4. Packaging area:

There should be enough space in the packaging area to ensure the orderly storage of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products to be inspected, qualified, unqualified, returned or recalled. Avoid confusion and cross-contamination of different products or materials, and avoid omissions or errors in production or quality control operations.

5. Storage area:

The design and construction of stem cell preparation cryopreservation bank should ensure good storage conditions, the freezing temperature should not be higher than-150℃, and there should be ventilation and lighting facilities, as well as necessary gas monitoring facilities.