Perfusion development and its potential for cell therapy manufacturing with adherent cells.

Area of Science:

• Biotechnology
• Cell Therapy Manufacturing
• Process Intensification

Background:

• Perfusion processing is a proven intensification strategy for recombinant protein production.
• Cell therapeutics manufacturing currently lacks scalable and efficient production methods.
• Rising approvals in cell therapy necessitate advanced manufacturing solutions.

Purpose of the Study:

• To review cell retention technologies and their application in perfusion processing.
• To explore the potential of perfusion for intensifying therapeutic adherent cell manufacturing.
• To assess the use of cell retention devices in downstream processing of therapeutic cells.

Main Methods:

• Review of historical cell retention technologies for suspension cell processing.
• Analysis of perfusion-based process intensification strategies.
• Evaluation of literature on perfusion processing for therapeutic adherent cells.
• Elaboration on the applicability of cell retention devices for cell harvesting and downstream steps.

Main Results:

• Perfusion processing can automate medium exchange and reduce contamination risk in cell therapy manufacturing.
• Technologies developed for suspension cell processing are transferable to adherent cell manufacturing.
• Scalable, single-use, Good Manufacturing Practices (GMP)-compliant perfusion systems are crucial for cell therapy development.

Conclusions:

• Implementing scalable, single-use perfusion systems with cell retention devices can accelerate therapeutic adherent cell manufacturing.
• Perfusion offers automation, reduced contamination risk, and stable cell quality for cell therapies.
• Translation of perfusion technologies from biopharmaceutical production to cell therapy manufacturing is feasible and beneficial.