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Webinar Series of the Chinese Antibody Society
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Continued process development for monoclonal antibody (mAb) for more efficient manufacturing schemes is required to meet ever increasing patient needs. Process development for most mAb manufacturing focuses on Chinese hamster ovary (CHO) cells, as this host is relatively mature and has a long history of producing products with demonstrated safety to patients, high process yields, and suitable product quality requirements for human use. MAb process development is divided into upstream and downstream processing. The focus of this presentation is the upstream portion, which starts with the thaw of a cell bank vial, proceeds to seed culture expansion, and then finally to production in large-scale bioreactors. Recent advances in upstream process development will be discussed, including cell line generation strategies, medium development, bioreactor parameter optimization, high throughput screening, process analytical technology tools, omics pathway analysis and process modeling, upstream control of quality attributes, platform development and implementation, and scale-up manufacturing. In the second half of the seminar, we will focus on three hot upstream topics in detail, e.g., upstream levers for control of drug substance quality attributes, process intensification for improvement of manufacturing productivity, facility throughput / cost reduction, and process development at pandemic speed for anti-SARS-CoV-2 neutralizing mAbs. Future perspectives will be summarized in the end.
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Dr. Yuansheng Yang
Developing therapeutic antibodies remains a technically challenging, extremely time-consuming and costly process. The process of developing therapeutic antibodies starts with discovery of antibodies with specific binding affinity and desirable functionalities, followed by production of antibodies in mammalian cells to provide enough high-quality materials for preclinical and clinical studies before getting …
Dr. John (Zhihua) Zhang
Monoclonal antibodies (mAbs) are a well-established product class of biotechnology-derived pharmaceuticals as evidenced by many FDA/EMA approved mAbs for the treatment of multiple diseases, such as cancers and autoimmune diseases. Monoclonal antibodies that are molecularly engineered for enhanced functions and pharmacokinetic properties have become increasingly popular for development by many …
Dr. Yi Zhu
The basic design concept of GNC (Guidance & Navigation Control) multispecific antibody are as follows: It is expected to activate and maintain the activity of Naive T cells in peripheral/lymphatic tissues (Priming & Activation), and mediate the targeted migration and infiltration of T cells from peripheral/lymphoid tissue to tumor tissue …
Dr. Xiaoying ZHANG
IgY is a key immune molecule across species.And we need diversified antibody R & D strategies.Developments of pIgY and IgY functional fragments have been well established. Increasing IgY products are in pipeline and registration, but there are still obstacles and solutions in IgY technology development and industrialization.