Biosimilars: Scale up from R&D to Commercial Stage

Abstract

The scale up of recombinant proteins involves a multi- dynamic strategic approach to achieve maximum output consistently. Various parameters during the fermentation will limit the synthesis of desired protein, which otherwise can be produced with ease in case of classical fermentation. In order to synthesis the protein, it is very important to understand the process at laboratory scale – both from scale up point of view and productivity improvement at large scale. Some of this parameters and scale up parameters are discussed below in this review.