Conceptual Development of Biologic Manufacturing Campus

Category: CMC Development and Manufacturing Consulting
Most of our clients work with CDMO’s and CMO’s in the early development stages. As one Biologic client progressed into late-stage development and potential market approval, they were eager to know how much would it take and how long would it take to develop their own manufacturing facility. Cilatus analyzed the predicted market demand of the clients products and then conceptualized an entire manufacturing campus including a single use (SUB) or stainless steel bioreactor manufacturing facility, quality control laboratories, a utilities building, a GMP warehouse and an lab/office complex. Then Cilatus engaged with two specialty subcontractors, one for process design, process simulation and cost of goods (COGS) calculation and another subcontractor for conceptual layout development and conceptual cost estimation. Together with these two subcontractors, Cilatus was able to provide the client with a complete conceptual campus layout, process design and scale options including all equipment required, COGS estimates for each product to be made, and a conceptual overall project cost. In addition, Cilatus developed with the client an organizational structure and a hiring plan for all employees necessary over time as the project developed from engineering, to construction and start-up. Other required client costs for the completion of commissioning and validation were also estimated, therefore giving the client a complete picture of the total project cost, cash flow over time, and a comparison to the current and future COGS of working with CMOs. References for this work and case study are available on request.