Clinical Trial Supply
Biopharma companies rely on our expertise and broad capabilities to produce the clinical trial drug product supply they need, when they need them. Many of our clinical stage customers start with us in the preclinical phase and progress through Phase II, as Cambrex provides agile end-to-end clinical supply services, simplifying the path for our customers.
Count on Cambrex for:
Clinical Trial Supply Capabilities
Our experts and facilities are equipped to manufacture clinical supplies as small as 1 kg for oral solid dosage forms with a variety of technologies, including:
- Wet granulation
- Dry granulation
- Fluid bed technology, including the use of solvents
- Tablet compression
- Film coating
- Stick pack filling — tablets and granules — for pediatric trials
- Liquid/suspension clinical supplies
- Powder-in-bottle (PiB) dosage forms
Dedicated Formulation Support
Our formulation experts are your technical resource during every step of your clinical development program. This close partnership and support ensure you receive the best possible advice based on scientific and technical guidance. A designated formulator stays committed to your project to ensure continuity and that the knowledge gained through development is maintained as you scale-up production.
Comprehensive Analytical Support
Throughout clinical development, we support all your analytical development programs. Our analytical laboratories are equipped with both UPLC and HPLC capabilities, as well as a full range of dissolution equipment. We also provide analytical method validation services for Phase I through commercial. Our stability services cover the entire range of ICH conditions, as well as specialized conditions.