Bioanalytical Techniques Applied on the Downstream Protein Purification Process

A study of the main bioanalytical techniques that are applied at different stages of the downstream protein purification process to ensure overall product quality control.
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Abstract 
This paper aims to identify and evaluate bioanalytical techniques applied in the downstream protein (DSP purification process) to get high-quality product quality control. There is a review of past research on bioanalytical techniques for downstream protein product quality control. The approach helps identify and collect relevant data and information on bioanalytical techniques and DSP processes. Data obtained from secondary sources is synthesized based on relevance to the research topic. Centrifugation, chromatography, and filtration methods are the main bioanalytical techniques in the harvest and filtration, the release of intracellular products, buffer exchange and concentration, purification, and formulation stages of the downstream protein purification process. Utilizing the most efficient techniques in each phase of downstream protein is essential to getting high-quality protein products.
Introduction 
Downstream processing (DSP) is required to separate, (isolate), refine, and purify a mixture of components, and there is a need to overcome bottlenecks. There has been advancement in protein production and purity, focusing on optimizing high yield production and purity in less costly means. In DSP, there is a focus on controlling product quality and purification, and it is helpful to differentiate the product and process-related contaminants (Rolinger, Rüdt & Hubbuch, 2020, p. 2). Protein purification often depends on the size, form, solubility, and surface charge of protein molecules, including biospecific affinity. A multistage downstream process is required to eliminate impurities and get the concentration of the required product. 
Obtaining the target protein product in a purified form. Effective downstream bioprocessing enhances protein purity, but there is also a decrease in process volume that needs to be addressed to avoid losing the protein products. Optimizing bioseparation is also prioritized to ensure product quality in downstream protein purification. Removing impurities is essential, so the whole downstream protein purification process achieves a high yield (Somasundaram et al., 2018, p. 2895). In biotherapeutic manufacturing, the DSP is the last stage where the target protein is harvested and purified. The research focuses on bioanalytical techniques in protein purification in the downstream processing stages and elaborates how the techniques are used.
Research Question: What bioanalytical techniques are applicable in the downstream protein purification processes to guarantee high product quality and control ?
Literature Review
Downstream Process Development
 Downstream protein purification is a multistep process that eliminates contaminants to ensure the protein product is pure and homogeneous. DSP is the last phase where the protein gets harvested and purified to achieve the desired product quality. The DSP steps for recombinant protein preparation follow similar steps but are also influenced by the expression host system (Tripathi, and S...