What to Consider When Conducting A "Make vs. Buy" Analysis For A Cell & Gene Therapy Facility

By Cory Proctor, Director; Joseph Neroni, Director; Christian Hermanas, Senior Project Engineer

Long before a product has achieved regulatory approval, a solution is needed for scaling up the process from the lab to a GMP facility. This process must be approached strategically in order to deliver lifesaving therapies to the patient population in a cost-effective manner. There are two options companies are presented with as they prepare to bring new products to market: contract scale-up and commercial production to a CDMO (Contract and Development Manufacturing Organization) which referred to as “buy”; or invest capital to design and construct an in-house GMP facility, referred to as “make”.

As leadership, investors and technical operations advisors begin to plan for clinical and/or commercial production and decide between “Make vs Buy,” there are several key questions that must be addressed.