Analytical strategies for the determination of protein modifications

Assessment of recombinant protein product purity and consistency has been successfully accomplished by using a battery of quantitative analytical methods. The development of analytical methods for product control requires an understanding of potential changes in protein structure which could be caused by degradation and modification. This paper will review some of the common mechanisms of protein degradation and common modifications which can occur during the fermentation/cell culture and purification processes. It will also present examples of analytical techniques which have successfully elucidated some of these changes in protein structure.