The key element in drug development is the need for speed. Each day that can be saved during the drug development process may result in one additional day of drug sales under patent. Our global network of leading edge R&D specialists possesses the expertise, flexibility and extensive equipment necessary to meet your needs during all stages of the clinical development process and commercial manufacturing.

• Route Selection
• Process Development & Scale-up
• Analytical Development
• Process Safety Assessment
• Stability Testing
• Process and Analytical Qualification & Validation
• Regulatory Competency

Cambrex is organized for rapid response. Our fast track evaluation process and global resources focus onon-time results whether you provide a technical package or want us to develop the route. The overall objective is to serve you with fast responses, maintain a reliable and trustworthy assessment, and provide an attractive and competitive offer.

With the appropriate equipment and know-how at several geographical locations, we can provide stability testing services at any stage in the development process.

Cambrex has longstanding experience with the safe handling of high energy compounds, especially thanks to the Alfred Nobel heritage at the Cambrex Karlskoga site. In order to ensure safe operations throughout the scale-up process, all new processes and materials are tested for their thermal properties using differential scanning calorimetry (DSC) and reaction calorimetry techniques performed in house.

As soon as a project start-up takes place, the project is managed locally at any of our four sites. Each site has experienced employees to provide efficient internal communication with few decision levels – thus communication and action are rapid and the degree of flexibility is high. A dedicated project team is put together and the participants can follow the project all the way from grams to tons. 

A core value during the performance of a project is open and frequent customer communication. From day one you will get direct access to the project team and the atmosphere is based on trust and open dialog.

In our state-of-the-art research and development laboratories at Cambrex, our staff of organic chemists,  designs synthetic routes to your target molecules and develops them to optimal commercial processes. The development and validation of analytical methods run parallel with the synthetic development to provide rapid enabling of your project.

We offer state-of-the-art kilo laboratories at our Cambrex Charles City (Iowa) site in the US, Cambrex Karlskoga, Sweden site and Cambrex Profarmaco in Milan, Italy.

When we bring forward your project from clinical phase to commercial production, you benefit from having a chemical process already developed specifically to meet the economic and practical requirements of large scale. Thanks to our longstanding experience in the production of pharmaceutical intermediates and APIs, Cambrex will consider all full scale aspects of the process already in small scale. As a result, you can save substantial time and money by choosing our premium development services.

We have taken many active pharmaceutical ingredients all the way from gram development to ton production, and possess a solid regulatory competency to serve your needs.

We avoid any late stage changes by anticipating the appropriate time to perform validation. We also bring you creative suggestions for process improvements at the right time. The result is a more secure product launch supply.

Cambrex offers flexible full scale facilities with the highest quality and GMP standards in Charles City, Iowa, US; Karlskoga, Sweden; and Milan, Italy. All sites benefit from our R&D organization, which allows us to achieve efficient and successful technology transfer. We have capabilities and experience handling and manufacturing commercial drugs.

For scale-up, Cambrex Pharmaceutical is proud to offer a number and range of top class cGMP pilot facilities that are unsurpassed. In the US, the Cambrex Charles City site offers several excellent piloting units, fully classified for cGMP production and controlled substances. In Europe, the Cambrex Karlskoga and Cambrex Profarmaco sites operate full pilot plants with excellent equipment utilizing cGMP conditions.  Each plant specializes in a range of advanced technologies and one operates by remote control. 

• Process Scale-up
• Process Improvement
• Process Safety Assessment
• Regulatory Filing

When you bring a commercial requirement directly to us, our global network of flexible resources can rapidly be adapted to accommodate the production up to multi-tonnage quantities. With our flexible set-up of production trains, new campaigns can be introduced with only minor modifications. We are proud to offer you the choice of several sites for production of your intermediate or API. If your process requires investment, we have the strength of a well capitalized, public corporation. Cambrex also has extensive experience with making tailor-made arrangements for more complex projects.

Our excellent scientific staff can often suggest process improvements to make your supply more cost efficient, even for previously commercial products. Our expertise in high energy compounds also enables us to add important process safety improvements at this stage.