Real-time process monitoring involves integrating physical sensors into production processes to acquire sampling methods. This approach is crucial for both the pharmaceutical and biopharmaceutical industries due to the complexity and sensitivity of synthetic and biological products. Implementing real-time monitoring ensures product quality, improved throughput, safety, and compliance by...
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...