Cambrex Case Studies

  1. Overcoming Limitations To Achieve Uniform Dosing 1/24/2022

    An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

  2. Selective Crystallization Of A Novel Polymorph 1/24/2022

    Discover how applied rigorous characterization standards and expert knowledge of critical water activity enabled the isolation of a previously undiscovered and uncharacterized polymorph.

  3. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

    Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

  4. Method Optimization: Assay Development Following Compendial Methods 1/20/2022

    There was a short time frame of only 7 weeks to complete assay optimization and conduct pre-validation studies within the confines of USP<621>.

  5. Method Development: Managing A Diverse Range Of APIs 1/20/2022

    See how the team developed analytical methods to support pre-clinical and future GMP production under tight timelines.

  6. Full IND Program: Exceeding Requirements For Submission 1/20/2022

    Follow a compound through a full cycle of IND development, from modifications to the synthetic route to formulation development and API manufacturing.

  7. Crystallization Process Dev: Ramping Up Bench-Scale Control 1/20/2022

    Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

  8. "Ultra High" Potency Development And Manufacture 1/20/2022

    A biotech with limited experience in the development and manufacture of high potency compounds sought to develop a process for producing a highly potent API used to treat an unmet oncology need.

  9. Speed To Market – API Large-Scale Commercial Manufacturing 1/20/2022

    Learn how a top 20 US-based pharma company achieved more capacity to meet commercial supply needs in an accelerated timeline followed by pre-approval inspection with the help of a CMO partner.

  10. Adapting To Change – API Custom Development And Manufacturing 1/20/2022

    A pharmaceutical company sought a development and manufacturing partner to assist with an in-licensed product originating from an emerging pharma company, a molecule in clinical Phase II / III trials.