Clinical Trial Supply

Biopharma companies at all stages of development 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 Phase I and progress through Phase III and beyond, as Cambrex provides agile end-to-end clinical supply manufacturing services through commercialization, simplifying the regulatory 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
  • Encapsulation
  • Tablet compression
  • Film coating
  • Stick pack filling — tablets and granules — for pediatric trials
  • Liquid/suspension clinical supplies
  • Suppositories
  • 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. From the bench to our pilot plant, up to production-size equipment, a designated formulator stays committed to your project to ensure continuity and that the knowledge gained through development is maintained for registration and commercial launch.

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.

Clinical Trial Supply Packaging Services

From solids to liquids to creams and ointments, our facilities in Whippany, NJ and Mirabel, Québec are equipped to meet your clinical study’s unique packaging requirements. We offer a wide variety of sterile and non-sterile packaging solutions for a range of dosage forms.

Connect with Cambrex

We love challenges, and we would like to learn more about yours. Contact us with your clinical trial supply questions or problems.

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