- Potential failures in the clinic or, even worse, an inability to manufacture because of an increase in the number of complex molecules in a company’s pipeline
- Under- or over-manufacture of a drug substance raw material because of demand uncertainty
- Limited access to right-sized capacity, driven by the bioprocess industry’s shift away from large-volume stainless steel tanks toward mid-scale bioreactors
- A company’s inability to find a manufacturing slot for its trial or product launch, given capacity limitations within contract development and manufacturing organizations (CDMOs) and biopharmaceutical organizations
- Missing first-to-market position as a result of increased competition.