Development of Fermentation Process

The pilot study is the basis of clinical and commercial production. In order to solve the practical problems faced by pharmaceutical enterprises, such as long process time of fermentation, low antibody expression, substandard antibody quality, and non-compliance with application requirements, we grandly launched the development service of fermentation process.

Our fermentation development service integrated four technologies of "plate / tube reactor screening, Gator high-throughput detection, matrix bioreactor and DOE experimental design", and established a robust cell culture process combined with systematic and comprehensive process control and product quality control.

It only takes 3 months to complete the development of cell culture process, the antibody expression is higher than the industry average level of 3-5 g/L, the antibody quality is up to standard, and the compliance meets the requirements of drug application.

Service Highlights

1. Surely standard antibody quality

• Purity: SEC-HPLC monomer ratio ≥ 95%, nrCE-SDS main peak ≥ 92%, CEX main peak ≥ 50%.

• Activity: The relative binding activity meets the requirements (70%-130%), and the biological activity meets the requirements.

2. Extremely compressed development period

• Experienced project management team ensures seamless connection between platforms, and completes one round of process optimization within 3-4 weeks.

• Mature and stable platform technology escorts the rapid process, and the development is completed in 2-3 rounds of tests.

3. International leading antibody production

• The average expression level of the upstream fermentation is 5-6 g/L, and the highest is 12 g/L.

• The average recovery rate of the downstream purification is 60%-80%, and the highest is 80%.

4. Compliance with drug declaration requirements

• The cell lines, culture medium, reagents, consumables and other materials meet the regulatory requirements. 

• The quality of the stock solution of the batch confirmed by the process conforms to the Chinese and US pharmacopoeia standards.

5. Four sets of authorized host cells

• Including Freedom CHO-S, HD-BioP3 Null CHO-K1, CHOZN, CHO-K1Q.

• A robust and efficient platform has been established for four sets of commercial authorized host cells.

6. Experience of more than 30 projects

• After more than 30 projects of repeated polishing and meticulous crafting, the cell culture process has been dramatically improved.

• Profound practical experience in increasing antibody expression, improving antibody quality, and reducing metabolic byproducts.