Background of the project

Glycosylation modifications of therapeutic antibodies (IgG type) account for more than 50% of all post-translational modifications, which have a great impact on the biological activity, safety and effectiveness of drugs.

Among them, the increase of Man5 content will increase the ADCC effect of the antibody, but it will also reduce the half-life of the drug in the body, and it has strong immunogenicity.

The production of high mannose type is affected by many factors such as cell line, medium, and process. Therefore, the content of Man5 is usually controlled within 5%.

Demand from the customer

The customer entrusted QuaCell to develop a customized medium, required to reduce the Man 5 ratio of the original product from 5.7% to less than 5%, and kept the yield and other quality data consistent with the original process.

Outcome of the project

According to the relevant data of customer needs and feedback,  QuaCell optimized the performance of 4 kind of media (Medium 1, 3, 8, 15) through two rounds of systematic media design and experiments.

( Picture 1 shows titer detection data of cells in each medium )

( Picture 2 shows detection data of cells in each medium Man 5 )

(  Picture 3 shows IEC detection data of cells in each medium ) 

Highlights of the project

• Within 2 months, QuaCell quickly obtained customized medium formulations through platform solution
• Man 5 ratio decreased from 5.73% to 3.12%, a reduction of nearly 46%
• Compared with the original process, the customized culture medium has increased by 20% in terms of product expression
• Compared with the original process, the main peak of IEC has increased by 13.3%, and the acid peak has decreased by 10.8%.