Preformulation, Formulation and Process Development

AMRI offers specialized aseptic formulation development and manufacture of small batches for early-stage clinical trials. Our Glasgow site, which is equipped with a dedicated cytotoxic suite, provides extensive technical expertise in the development, scale-up and GMP manufacture of liquid and lyophilized sterile dosage form products and offers solutions for a variety of compound categories, such as small and large molecules and controlled substances.

Our complete suite of capabilities for sterile injectable drug product formulation and clinical stage manufacturing services includes:

Preformulation

  • Material sciences
  • Formulation screening
  • Excipient compatibility
  • Solubility and stability enhancement, including in-use assessment

Formulation Development

  • Simple liquid formulation development
  • Lyophilized formulation development
  • Lyophilization cycle development and optimization
  • Complex liquid formulation development

Process Engineering

  • Liposomes and nanoparticles
  • Suspensions

Key Development and Analytical Capabilities

  • Freeze drying microscopy
  • Dynamic light scattering
  • Differential scanning calorimetry
  • Microflow imaging 

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