Analytical/Process Development

With our experience and expertise in small scale to commercial production of pharmaceutical intermediates and APIs, Cambrex can thoroughly develop your project from clinical phase to commercial production, while taking into consideration all full-scale aspects of the process already in small scale. As a result, you benefit from having a chemical process already developed specifically to meet the economic and practical requirements of large scale.

We avoid late stage process changes by anticipating the appropriate time to perform validation. We also bring creative suggestions for process improvements at the right time. The result is more confidence and better preparation of your product launch supply.

Analytical and Process Development Capabilities

• Route selection
• Literature/database/patent searches
• Go/No-go feasibility evaluations of key reaction steps
• 1-10 gram proof-of-concept lots
• Toxicology lots for animal studies that can be scaled-up with confidence
• Clinical drug substance supply
• Method development
• Stability indicating assay methods
• In-process testing methods
• Raw material testing
• Stability testing
• Method qualification