Scale-Up → Challenges within Scale-Up

Maintaining the quality and integrity of a drug during scale-up is essential for companies that wish to uphold high standards and legal compliance.

Challenges to scale-up include:

• Contamination: One of the largest concerns pharmaceutical manufactures face when transitioning from small-scale to large-scale operation is the higher risk of product contamination.
• Regulation: It is important that pharmaceutical manufacturers be aware of regulatory considerations especially because different jurisdictions have different guidelines. Scale-up must be validated with SUPAC guidelines every time it grows by a factor of at least ten.
• Manufacturing: Any step of the manufacturing process may affect the purity profile of a drug which poses a challenge for previously conducted safety studies.