Implications of inaccurate forecasting on biologics drug substance manufacturing


Large molecule drug substance manufacturing and demand forecasting is riddled with complexity. The long cycle time and short shelf life of a 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. Biopharma companies and their partner CDMOs are now implementing various measures to instill more flexibility into their manufacturing processes, including single-use parts, dual sourcing, and modular design.