How Can A Cell Therapy Manufacturer Avoid The Impact Of Supply Chain Disruptions Via Single Use Systems (SUS), While Also Being Sustainable For The Environment?

A: THE KEY IS TO ADOPT A COMPREHENSIVE, "RISK-SMART" APPROACH to supply continuity and control. Suppliers should use effective demand planning/forecasting, along with planning for capacity, business continuity, disaster recovery, change-control management, supply-chain mapping, and continuous improvement. A cross-functional team of experts constantly assessing risks related to demand volatility/forecast accuracy, manufacturing capacity, process and equipment, sole/single-sourced raw materials, facilities (e.g., water, utilities, power, information technology/systems), and other factors could help, too. This way, risks above a certain risk priority number are mitigated and monitored. Finally, your business continuity plans must be revisited on a regular basis, and risk mitigation activities continually updated. As for sustainability, reducing the cost of operations and minimizing the impact on the environment are complementary in the case of SUS, as the technology has been shown to have a net positive environmental impact.

RAÚL E. DIAZ directs MSD Animal Health Large Molecules Biopharm Operations in Montes Claros, Brazil. He has managed Merck manufacturing facilities in Europe, Mexico, and the U.S.