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