![]() ![]() The remaining process steps include virus ltration (VF) and ultra ltration/dia ltration (UF/DF) to formulate and concentrate the product, which is now the bulk drug substance. Finally, future directions in mAb processing are summarized. FIGURE 1.3 Typical mAb platform (current). A scalable high-yield exosomes production process was developed using HEK 293. Cell culture processes for monoclonal antibody production. Exo: exosomes PFD: process flow diagram mAb: monoclonal antibody. A brief description of process characterization and validation activities for these molecules is also provided. Design and Engineering of Trastuzumab emtansine production plant. Aspects that can be readily templated as well as those that require focused development effort are identified for each unit operation. Key elements of each type of unit operation are discussed along with data from 14 mAbs that have undergone process development. The platform hinges on the successful use of Protein A chromatography as a highly selective capture step for the process. An initial screen to select the best clones is followed by further application specificity testing and optimization. This platform consists of a well-defined sequence of unit operations with most operating parameters being pre-defined and a small subset of parameters requiring development effort. The selection process for monoclonals includes two stages. Here, we describe the key elements of a flexible, generic downstream process platform for mAbs that we have adopted at Amgen. In our experience, significant biochemical differences and the variety of challenges to downstream purification make the use of a completely generic downstream process impractical. Taking advantage of the biochemical similarities in this product class, several templated purification schemes have emerged in the literature. This therapeutic modality has become increasingly important with the recent approval of several drugs from this product class for a range of critical illnesses. This paper presents an overview of large-scale downstream processing of monoclonal antibodies and Fc fusion proteins (mAbs). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |