| Popis: |
The clinical success of monoclonal antibodies (mAbs) has been accompanied and complimented by the development of innovative mAb products, technologies, and manufacturing processes. This article reviews information on new and emerging mAb products and product classes, and manufacturing and testing issues such as the use of platform processes, disposable and small-scale bioreactors, quality by design, and new analytics. Regulatory concerns related to these issues as well as those related to newly identified product-related impurities, and demonstration of product comparability after manufacturing changes are made, are also discussed. |
