The Impact of Six Critical Impurities on Recombinant Protein Recovery and Purification from Plant Hosts
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2018 John Wiley & Sons, Inc. Molecular pharming of plants for recombinant protein expression has undergone several shifts in focus since inception. Initially, achieving commercially viable protein expression levels was the primary focus without giving much attention to the downstream processing (DSP) and critical plant-derived impurities. Thus, there is an increasing need to further develop robust and efficient DSP operations following recent successes of plant-based recombinant proteins in clinical trials and in the FDA regulatory approval process. There are several nuanced challenges that arise during DSP of seed-, leaf-, and bioreactor-based expression platforms. These challenges or critical impurities are proteases, native host proteins, phytic acid (salts), polysaccharides, phenolics, and pigments. While mitigation strategies to circumvent the effects of these impurities have been independently developed on a case-by-case basis, this chapter describes the critical impurities and proposes measures whereby impurities can be minimized during extraction or removed during further downstream processing.
