Clinical API Manufacturing
Reliable manufacturing of drug substances for clinical trials is critical for any pharmaceutical company, but it can be particularly challenging for small and emerging organizations if they lack the in-house expertise, capacity or scale needed as the demand becomes greater in later phases.
At Cambrex, our flexible clinical manufacturing services can supply the clinical trial drug substance materials you need to meet your changing demands. We work closely with your team to understand the clinical development plan and to provide a nimble and flexible clinical manufacturing solution. Our highly trained operations team collaborates closely with our process chemists and process engineers, who accompany the process into the pilot manufacturing facility to ensure smooth transfer to later-phase clinical batches through commercial launch.
We operate multiple manufacturing facilities to meet the varying demands of clinical trials, with the capabilities to produce active pharmaceutical ingredients (APIs) for Phase I through large Phase III trials and beyond:
Support for non-GMP synthesis of APIs and intermediates up to 10 kg.
Durham, NC, USA
Support for Phase I through Phase II with capacity from 1 L to 200 L.
Longmont, CO, USA
Support for Phase I through Phase II with capacity from 5 L up to 200 L.
High Point, NC, USA
Support for Phase I through commercial launch with capacity from 5 L to 2,000 L.
Charles City, IA, USA
Support for late Phase II through commercial launch with capacity from 400 L to 16,000 L.
Support for late Phase II through commercial launch with capacity from 50 L to 12,000 L.
Paullo (Milan), Italy
Support for late Phase II through commercial launch with capacity from from 37 L to 14,000 L.
Our experts and facilities are equipped to handle your unique clinical trial demands. By choosing Cambrex as your clinical manufacturing partner for an upcoming trial, you can be confident that you will receive high-quality API and exceptional support at every step.
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Looking for a partner that balances passion with painstaking attention to detail? Speak to one of our experts about how we can help you run a successful clinical trial.Get in touch with an expert