Streamline The Path To FIH Trials With Advanced Cell Line Development

Cell line development (CLD) is the foundation for any successful biologic. The goal is not to create a cell line just good enough to advance to the next phase of development; it is to optimize a cell line for seamless advancement into process development, manufacturing, and commercialization.

An inexperienced partner may claim expertise but then struggle to meet protein production expectations and/or to minimize impurities. Neophyte CDMO partners also may encounter problems functionalizing the protein through post-translational modifications (PTMs), including linkages, cleavages, and chemical alterations. KBI Biopharma anticipates and plans for the impact of every upstream action on downstream development, as well as understands the costs associated with the development and manufacture of complex molecules.