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Crystallization Expertise

From solid form selection to large scale manufacturing

CARBOGEN AMCIS' solid-state experts are your partner for in-depth solid form study and selection of API candidates, delivering processes, featuring the requirements of your scale and clinical phase.

Defining the best crystalline form of an API is crucial in drug development, since it has a significant impact on the effectiveness of the formulation and, therefore, the bioavailability of the finished dosage form. Control of these solid-state properties, namely particle size and habit, polymorphic form and state of hydration as well as crystallinity, are core competences of our team. Design of crystal growth dominated systems improves filtration and drying properties, reduces impurity inclusions and delivers control on particle size and morphology.

Our data-driven approach for characterization of the solid phase is based on extensive analytical capabilities, including solubility investigations, the major corner stone for crystallization development. Beginning on small scale, focusing on form control, yield and purity, processes are further scaled-up. Geometrical similarity  of lab and production vessel design alongside computational tools, are the basis for down- and up-scaling capabilities enhancing reproducibility and process control.

Our Crystallization Capabilities

  • Salt screening and salt selection
  • Polymorphism screening
  • Solubility and crystallization screening
  • Small-scale crystallizations based MSZW or saturation profiles
  • Identification of critical parameters for up-scaling, investigation of filtration and drying parameters
  • Continuous crystallization
  • Preparation of amorphous solids via spinodal degradation, spray-drying or lyophilisation
  • Quantification of amorphous content
  • Solid-state characterization via XRD, DSC, TGA, HPLC (CAD/DAD), IC, NMR, DVS, XRPD-DSC, KF, GC, and PLM

For more information about our analytical capabilities to support crystallization development, download our brochure.