High Potency Development and Manufacturing

Since 1998, Cambrex has been the solution for your High Potency and oncologic API and intermediate development needs. Using rigorous controls and isolation technology, partnering with Cambrex for the development and manufacture of new and existing High Potency and oncologic APIs provides assurance and piece of mind.

Our High Potency and oncologic development capabilities

• High Potency Development Center at Cambrex Charles City
• Chemical development labs
  • Small scale cGMP lab up to 5 L
  • Analytical lab
• cGMP kilo labs
• Laboratory scale micronization capability for development
• Controlled access to all development, production and storage areas
• Barrier isolation technology
• Separate gowning, degowning and misting areas
• Project specific PPE requirements
• ISO Class 8

Risk Assessment

During the development of High Potency and oncology APIs, Cambrex uses a risk assessment approach to screen and assign Occupational Exposure Limits (OELs) to APIs and intermediates with unknown toxicological properties. This advanced methodology uses real-time data to establish OELs, allowing Cambrex to eliminate assumptions and artificial safety factors.

• Provides for data-driven risk management decisions
• Decreases time spent using excessive containment controls                                                   
• Lowers manufacturing costs
• Adapts to a wide range of manufacturing scales

Cambrex employs the traditional Exposure Control Band (ECB) methodology for APIs and intermediates with known toxicological properties. The ECB defines general health concerns, administrative and regulatory requirements, monitoring strategies and facility design requirements.