Downstream Processing In The Age Of Precision Medicine: Trends And Challenges

By, William Barrett, PhD, GORE PharmBio

Drug development and manufacturing have undergone a seismic shift in the last two decades, from blockbuster small molecules to highly personalized biologics and cell and gene therapies. While the drugs may offer significant value for patients, smaller batch medicines may not be financially feasible for a larger company to manufacture – especially if they have a broader pipeline. Companies are now working to address this disconnect, optimizing their processes for smaller batch biologics.

This article discusses one of the key areas where innovation is needed: downstream processing. Surveys show downstream processing remains a serious bottleneck – one that significantly impacts overall production. Surging demand for treatments and vaccines fueled by the COVID-19 pandemic has only exacerbated these bottlenecks. Many have been exploring alternative processes and products, such as new chromatography columns that better reflect modern manufacturing needs. Biopharmaceutical leaders urgently need these kinds of solutions to improve the productivity, efficiency and flexibility of downstream processing.