Whitepaper: Downstream biopharmaceutical operations

The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD…

The Process Analytical Technology (PAT) initiative of the U.S. FDA provides a framework for implementing principles of “Quality by Design” (QbD), which promotes quality assurance through understanding and controlling the critical process parameters that affect a biologic product’s critical quality attributes. To this end, rapid, non-destructive spectro-scopic methods offer significant monitoring and control options for bioprocess unit operations such as in situ monitoring of purification cycles, buffer identification, protein aggregation, product identification, and quality control. 

Extending process understanding to downstream bioprocesses is vital to ensure high-quality biological products. Current research is focused on gaining a better understanding of biologic downstream steps by quantitatively measuring key analytes such as amino acids, sugars, and proteins. Similar technology has been used to trend nutrient and metabolite concentrations in situ and in real time during upstream bioprocessing stages. Raman spec-troscopy is uniquely useful for biotechnology QbD applications because it enables fast, non-destructive monitoring and control.