Currently the instruments used in the pilot platform of mammalian cell expression system are NBS cell tanks 2.2L, 7L, 40L, and 150L; multi-functional cell culture analyzer and handheld CO2 analyzer for rapid analysis of the main or key nutrients, metabolites and gases in the cell culture medium; flow cytometer for rapid and accurate detection of cells; enzyme immunoassay detector and fluorescence microscope for subsequent detection. Enzyme-linked immunoassay detector, fluorescence microscope and so on. The development and optimization of large-scale high-density mammalian cell culture

process and small-scale production can be carried out rapidly.

1. This pilot platform is capable of developing, scaling up and validating pilot processes for mammalian cell expression systems, and preparing small-scale samples.

2. Rapid screening and optimization of cell culture medium by DOE method, screening of low-serum and serum-free medium, simplifying the means of isolation and purification, and improving the safety and yield of biologics.

3. Carry out mammalian cell high-density culture, optimize the control parameters through the NBS cell tank, and carry out the mapping and optimization of the replenishment process to improve the yield and reduce the cost.

4. Scale up from 2.2L-7L-40L-150L fermentation scale to find out the process difficulties in the scale-up process, and provide technical guarantee for the scale-up production.

5. Realize process validation in small and medium scale trials to provide data support and experience accumulation to ensure the final product quality.

6. Small-scale sample production, providing a source of samples for subsequent tests.