Challenges, risks, and strategies for biologic drug substance manufacturing


Insights from pharmaceutical and biotechnology industry leaders make it 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 accurately 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. Solutions like flexible capacity, modular and disposable technologies, continuous manufacturing, and options such as multiplexing can help biologics companies de-risk and avoid missed opportunities.