Antibodies
For different products in the biopharmaceutical industry (e.g. monoclonal antibody, bispecific antibody, polyclonal antibody, ADC, fusion protein) and different culture modes (e.g. batch, fed-batch, perfusion, high-density N-1 culture, etc.), BioEngine has developed Eden series CHO Cell CD medium by using its huge formulation library and patented iBioG-Med development platform. This medium can support the high-density culture of CHO cells and the efficient production of therapeutic proteins, and the expression and quality of the protein products are comparable to global brands. Besides, BioEngine provides cell culture technical services, including medium formulation development and process optimization, to meet different quality requirements. The media of BioEngine have a large number of successful application cases for mainstream production cell lines such as CHO-K1, CHO-ZN, CHO-S, CHO DG44, HORIZON, etc.
Currently, BioEngine has served 60+ antibody/fusion protein projects, including 4 marketed product projects, 20+ phase I-II clinical projects, and 30+ IND projects.
Serving
Biosimilars and innovative drugs (Monoclonal antibody/multi-specific antibody/Mab fusion protein)
Traditional targets (CD20/HER2/PD1 etc.) and new targets (CD38/IL6 etc.)
*The statistical data as of June 2022.
Typical Cases
| No. | Update | Antibody type | Culture method | Features |
|---|---|---|---|---|
| 01 | Marketed | Antibody fusion protein | Traditional fed-batch | 6-fold increase in titer CQAs comparable with the RLD |
| 02 | BLA | Monoclonal antibody | Traditional fed-batch | 3-fold increase in titer CQAs comparable with the RLD |
| 03 | Phase III clinical trial | Monoclonal antibody | High density fed-batch | 2-fold increase in titer Manufacturing process change |
| 04 | IND | Tetra-specific antibody | Traditional fed-batch | 3-fold increase in titer Meet CQA requirements |
| 05 | IND application in both China and the US | Bispecific antibody | Perfusion |
A 12-fold increase in yield compared with traditional fed-batch process |
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