Isoelectric Focusing, Matrix-assisted Laser Desorption/ionization Time-of- Flight Mass Spectrometry, Electrospray Ionization Mass Spectrometry

LEVEL: INTERMEDIATE D iscovery, development, and commercialization of novel biologics frequently involve collaboration between two or more companies. In the context of these business relationships, transfer of technology from one institution to another is a crucial step that needs to be executed f lawlessly and rapidly. Follow-up activities usually include the development of productive, reliable, and scalable processes and are equally important because they are usually on the critical path to market. In the context of the licensing of a therapeutic antibody for the treatment of cancers over-expressing the insulinlike growth factor I receptor (IGF1R), this two-part article describes the steps and timelines that led to successful and rapid transfer of technology and its subsequent scaleup. These activities produced antibody used in preclinical and early clinical evaluations. Transfer of technology and its scale-up by ~150-fold was completed within a period of three months, and development of a more productive process and its ~1,000-fold scale-up was completed within about nine months. In the March 2008 issue of BioProcess International, the first half of this article listed materials and methods for the studies, detailed assay development and analytical methods involved, and provided analytical results before summarizing the initial scale-up efforts involving a batch process. This month concludes with a detailed discussion of the fed-batch process scale-up.