Cambrex Industry Insights

  1. Peptide Synthesis: Delivering Cost-Effective Strategies 1/24/2022

    For peptide APIs, using a liquid phase peptide synthesis (LPPS) approach offers a cost-effective process for large-scale manufacture by eliminating the need for specialized equipment and excess raw materials.

  2. Crystallization Process Development: Peptide Crystallization 1/24/2022

    Whether performed during formation of an API or as a means to purify intermediates, achieving control of nucleation and crystal growth is critical to designing a successful peptide crystallization process.

  3. 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.

  4. 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.

  5. 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.

  6. 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>.

  7. 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.

  8. 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.

  9. 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.

  10. Painkiller And Sedative Demands: Effects On Bupivacaine HCI Supply 1/20/2022

    As global authorities work to fill gaps, drug manufacturers and CDMOs have become critical in the efforts to stabilize the supply of Bupivacaine HCl and other essential drugs.