We recognize that late stage process changes can cause unnecessary project delays. That’s why we take a proactive approach to pharmaceutical process development and validation.
At Cambrex, we use our experience and expertise to efficiently bring your small molecule intermediates and APIs from early clinical phase to commercial production.
Our talented team are forward-thinkers and take into consideration commercial scale aspects of the process during early stage development. As a result, you benefit from having a chemical process already developed specifically to meet the economic and practical requirements of large scale production.
Our pharmaceutical process development services combine creative solutions to early phase challenges with a thorough knowledge of the rigours of validation. As a result, we can help you to avoid late stage process changes, which could impact your time to launch. The result is more efficient preparation of your APIs and intermediates and greater confidence in your project’s success.
Our analytical capabilities and pharmaceutical process development services include:
- Analytical method development and phase appropriate validation
- ICH stability studies (storage and testing)
- Reference standard qualification
- Product release/ product retain
- 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