Clinical Trial Manufacturing

Through our Longmont, Colorado site, we provide comprehensive drug product manufacturing solutions designed to meet the highest standards of quality and compliance. We excel in supporting early-phase clinical trials, offering specialized services that encompass everything from formulation development to clinical supply manufacturing. Our team works closely with clients to understand their unique needs and challenges, delivering tailored solutions that enhance the speed and quality of drug development. By leveraging our deep industry expertise and innovative approaches, we help ensure the success of your early phase trials.

GMP Suites

Our four GMP suites are specifically designed to support Phase I and Phase II formulations:

Phase I Formulations

• Batch Sizes – Approximately 1,000 – 25,000 units.
• Capabilities – Neat drug or simple blends in capsules, powder in bottle for reconstitution at clinical sites.
• Focus – Speed, flexibility, and quality.

Phase II Formulations

• Batch Sizes – Approximately 25,000 – 150,000 units.
• Capabilities – Immediate release tablets and capsules, enteric/extended-release tablets, and solutions/suspensions.
• Proof-of-Concept – Robust formulation and process development with minimal changes required for commercial launch.

Manufacturing Capabilities

We offer a wide range of manufacturing capabilities to meet your drug product needs:

• Scale-Up Formulation – Expertise in formulation and process development with DOE experience.
• Granulation – Efficient dry and wet granulation processes to ensure product consistency and quality.
• Micronization and Milling – Micronization and milling techniques for optimal particle size distribution.
• Blending and Mixing – Precise blending and mixing services to ensure uniformity and consistency in your drug products.
• Tablet and Capsule Manufacturing – State-of-the-art equipment for the production of high-quality tablets and capsules.
• Packaging and Labeling – Comprehensive bottle and blistering packaging solutions for clinical site distribution.

Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to clinical trial.