Preparing For Next-Generation (or Future) Biopharmaceutical Manufacturing

Drug pricing challenges, exacerbated by the CoVID-19 pandemic, mounting labor costs and an uncertain economic landscape are all affecting performance of the biopharmaceutical industry. Ongoing pressures to update legacy biopharmaceutical systems and processes and integrate upstream and downstream bioprocessing workflows round out the many obstacles to overcome.

The biopharmaceutical industry, along with the Contract Research Organization (CRO) community, has invested significant research and development dollars to develop a strong clinical pipeline: 992 phase 3 studies for biological molecules (Source: clinicaltrials.gov as of March 2021). Responding to the rapidly changing manufacturing requirements of these novel biologic therapies means tackling some of the biggest challenges that have the potential to hinder this evolution. One such area is productivity improvement and technology advancements in manufacturing. From a manufacturing perspective, stringent requirements to achieve consistent quality are driving companies to optimize their operations. This requires a holistic approach to re-engineer manufacturing, both at the front end and at the downstream commercial stages.

In this article derived from a recent webinar panelists discuss how innovative digital technologies can address challenges faced by biopharmaceutical companies to overcome limits on manufacturing productivity and scalability.

While the early days for mAbs were a bit unsteady, the science behind these therapies is now well accepted. While comparing developments in the cell and gene therapies to what industry has seen in the mAb space, there are many important lessons that can push the current results coming from the clinic for cell and gene therapies. Digital technologies will be required to address challenges faced by biopharmaceutical companies to overcome limits on manufacturing productivity and scalability. Access to data is just not enough - the industry needs different bioprocessing use cases, and they will be a key differentiator either around real-time analytics or factory-in-a-box solution.

In this article derived from a recent webinar panelists further discuss how innovative digital technologies can address challenges faced by biopharmaceutical companies to overcome limits on manufacturing productivity and scalability.

Originally published by Frost and Sullivan