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Formulation Development

The formulation scientists at Catalent have experience in a variety of formulations and product presentations. The development team will integrate the biophysical and biochemical characterization of your molecule with the final product format, developing a formulation that will ensure delivery of a stable product to the patient. For products that need the added stability of lyophilization, the required lyophilization cycles can be optimized through the use of a LyoStar II™ development lyophilizer. Whether your molecule requires a liquid or lyophilized formulation in a vial or syringe presentation, Catalent has the experience and capabilities needed to develop and deliver your clinical or commercial formulation.

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  • Molecular Developability
    • Forced degradation
    • Molecular Operating Environment
  • Conformational Stability
    • UNcle, Wyatt DynaPro III, NanoDSC, ΔG
  • Colloidal Stability
    • Dynamic and Static light scattering
    • Solubility assays
  • UV/Vis Spectrophotometry
    • SoloVPE and Lunatic
  • UHPLC Waters Acuity H class and Premier
    • PDA, FLR, CAD, and QDa detectors
  • CE-SDS with Caliper and Maurice
  • cIEF with Maurice and CZE with Caliper
  • Potency Assay with ELISA, BLI and ITC
  • Solution characterization
    • Low and high-throughput pH meter
    • Viscosity with VROC Initium Plus and LOVIS 2000
    • Density with DMA35 and DMA4500
    • Tg and Tg’ with modulated DSC
    • Tc with freeze drying microscope
  • Subvisible particle analyses
    • MFI, FlowCAM, AURA, and HIAC
  • Biophysical Characterization
    • EAF4, AUC, DSC, KF, CD
  • DP Process
    • Peristaltic and time pressure filler
    • Material Compatibility, Freeze/Thaw, Mixing, light sensitivity studies.
    • LyoStar III lyophilizer
  • Automated Processing
    • TECAN, Big Tuna, EpMotion.

LyoStar II is a registered trademark of SP Industries Inc.