Microtools for single-cell analysis in biopharmaceutical development and manufacturing

• Microtools for single-cell analysis with potential application in the pharmaceutical industry.
• Key industry challenges in development of biologic drugs.
• Understanding single cells is critical for reducing timelines for biologic development.
• Advantages and limitations of classes of microtools for single-cell analysis.

Biologic drugs are promoting growth in the biopharmaceutical industry. Despite the clinical benefits of these drugs, the time and costs required to bring new biologics to market still are substantial. Three key challenges, among others, persist in the development of biologic drugs: namely, establishing product similarity, product toxicity, and global accessibility. New classes of microtools that facilitate the isolation and interrogation of single cells have the potential to impact each of these challenges. This opinion considers recent examples of microtools with demonstrated or potential utility to address problems in these areas. Integrating these advanced technologies into the development of new biologics could greatly reduce time and costs required to bring alternative products to market, and thus expand their global availability.