Large molecule drug substance manufacturing and demand forecasting is riddled with complexity. The long cycle time and short shelf life of biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. As a result, inaccurate demand forecasts can have significant implications for companies developing biologics. And with less industry-wide available capacity for biologic production, it is increasingly difficult to locate capacity to respond to demand changes and ensure products achieve commercial goals.
To better understand the issues that biopharmaceutical companies face when planning for clinical and commercial biologic drug substance manufacturing and supply needs, ORC International conducted interviews with biopharmaceutical executives in North America and Europe who consistently utilize forecasts for drug substance and commercial manufacturing planning for biologics. This research explored the causes, consequences, and potential solutions to forecasting challenges specifically related to biologic drug substance manufacturing.