Over recent decades biotechnology has made significant advances owing to the emergence of powerful biochemical and biophysical instrumentation. The development of such technologies has enabled high-throughput assessment of compounds, the implementation of recombinant DNA technology, and large-scale manufacture of monoclonal antibodies. Such innovations have ultimately resulted in the current experienced biopharmaceutical stronghold in the therapeutic market. Yet aggregate prediction and profiling remains a challenge in the formulation of biopharmaceuticals due to artifacts associated with each analytical method. We review some emerging trends and novel technologies that offer a promising potential for accurately predicting and profiling protein aggregation at various stages of biopharmaceutical product design.
- product development
- quality by design
- biopharmaceutical aggregation