Defining a robust production process for a recombinant protein product comes with various challenges. From the earliest stages of development, it is key to have a thorough understanding of how your product evolves during fermentation, harvesting, downstream processing and beyond. Given the biological nature of the manufacturing process, recombinant proteins are prone to physicochemical modifications such as aggregation, precipitation, degradation as well as(intentional or accidental) post-translational modifications (e.g. oxidation, deamidation, isomerization, phosphorylation). In addition, various organic compounds present during fermentation need to be monitored from process start to the final product (e.g. raw materials, host cell proteins). All of these compounds can have a significant impact on final product safety and efficacy so close analytical control is a must-have. In this presentation we will give an outline of the main assays used in recombinant protein production as well as a few real-life examples on how these tools will help finetune and upscale the manufacturing process (e.g. batch-to-batch comparisons). 

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