High Titre, Robust Cell Culture-Bioworkshops-康日百奥生物科技

Cell Culture

Segregated cell culture process development laboratories provide capability to identify top cell pools and clones, screen media, and optimize product expression and key quality attributes with the capacity to execute up to 4 upstream development programs in parallel.

Our Cell Culture Process development team has broad experience in different types of biologics. We utilize our experts’ deep process development skills, high- standard facilities, and rational experimental design, to establish robust, high-quality and low-cost cell culture processes covering every stage of biologics development.

Services

Media screening and feed strategy optimization
Process development in bench-top bioreactors
Process scale up study in pilot scale bioreactors
Product quality attributes optimization
Late stage process develop-ment and characterization
Material generation for pre-clinical studies

Case Study

Challenge:

The content of Man 5 was 17.7% in the initial process, which was much higher than the expectation of client;

Solution/Result:

Through medium combination changing, culture duration shortening and substrates, the Man 5 content decreased to less than 10%, which finally met the requirements of client.

Challenge:

The G0F content is lower and G1F content was higher than those in the reference sample, which affected the similarity between the product and reference sample.

Solution/Result:

By adding substrates related to the glycosylation modification, the G0F content significantly increased and the G1F content reduced without the lost of titer.

Challenge:

The Man 5 need to be controlled below 5%. Galactosylation species need to be higher than 32%. Afucosylated species must be controlled within the range of 5~8%;

Solution/Result:

Through adding substrates related to glycosylation modification, the Man 5 was significantly decreased to 3.6%, and the content of Galactosylation and afucosylation finally met the requirements.

Challenge:

In the iCIEF results of initial process, the acid peak content was high and the main peak content was only 49.3%.

Solution/Result:

Through the optimization of temperature control strategy and additives, the acid peak content was finally reduced to about 20% and the main peak content was increased to nearly 70%.

The initial bioreactor process had low protein expression. The process was optimized without changing the cell line and medium combination, and the protein expression was significantly improved.

Typical Cell Culture Workflow

Step 1

4~6 weeks

Technology Transfer

Technology transfer

Cell line transfer

Cell line in-house safety test.

Step 2

4~6 weeks

Media Screening in Shake Flasks

Basal/Feed screening

Quality attributes optimization

Step 3

4~6 weeks

3L Bioreactor Runs

Feed strategy optimization

Parameter optimization （pH, Integrate Viability Cell Concentration, Temp., Growth profiles, Metabolism profiles, Titer, Aggregation, Charge, Glycosylation ）

Step 4

~4 weeks