Challenges, Risks And Strategies For Biologic Substance Manufacturing

ORC International’s study highlights issues inherent in forecasting biologic drug substances. From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production. The biologics development and approval process is typically long and complicated, increasing the risk of inaccurately forecasting demand. Overestimating demand can lead to higher per unit cost and disposal expenses, and underesti­mating it can result in missed market opportunities and negative reputational consequences for the company.