Cell Line Development Overview

Production of recombinant proteins in animal cell culture for research, clinical development, and commercial purposes necessarily begins with the construction of a suitable cell line. The choice of expression system and mode of expression is generally based on the nature of the protein to be expressed, the quantity of material needed, and the timeframe over which maintained production is required. Mammalian expression systems are generally favored for the production of large, highly disulfide bound or glycosylated proteins. For production of small quantities of such molecules over a short timeframe, transient expression systems can be the method of choice whereas for clinical or commercial production, stable expression systems capable of continuous product expression over prolonged periods (months) generally are required. This chapter will discuss in detail the steps involved in the process of construction, selection, and screening of stable cell lines for industrial production of biotechnology products (Fig. 1).

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