Challenges, Risks, and Strategies for Biologic Substance Manufacturing

Challenges, Risks, and Strategies for Biologic Substance ManufacturingORC International’s 2016 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 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.

Read Patheon’s perspective to the ORC study in “Challenges, Risks and Strategies for Biologic Substance Manufacturing” and discover how biologics companies are increasingly demanding modular and disposable technologies and continuous manufacturing because of the need for flexible capacity.

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