Tony Khoury, Executive VP; Christian Hermanas, Senior Consultant; and Salome Philip, Consultant at Project Farma
Calculating viral vector yields is essential to determine how much drug product is needed for a specific gene therapy. This calculation will determine either how much internal manufacturing capacity is needed or how much it may cost to manufacture at an external contract development and manufacturing company (CDMO). This analysis is critical for any gene therapy organization looking to scale from preclinical to clinical to commercial.
Years of industry experience has led to the development of a valuable yield calculation tool that can serve as a vital prerequisite of the “make vs buy” analysis, which compares the feasibility and cost of building internal manufacturing capacity versus using an external CDMO. The calculation results reveal if the process is robust enough to meet the market demand of the target patient population. If the calculation reveals that the yields are very low compared to the target population size, then the process may need to be refined before attempting to scale up. If it is ready to be scaled up, valuable insights can be gained in determining how much facility capacity, and therefore capital, will be required to proceed with commercialization.