Products and Services

Pre-formulation, Formulation & Process Development

AMRI Glasgow Ltd., located in the United Kingdom, focuses on the aseptic formulation development and manufacture of small batches for early stage clinical trials, complementing AMRI's front-end formulation expertise. This site, which is equipped with a dedicated cytotoxic suite, has extensive technical expertise and experience in the development, scale-up and GMP manufacture of liquid and lyophilized sterile dosage form products and has the ability to work with a variety of compound categories, such as small and large molecules and controlled substances.

Core capabilities of AMRI Glasgow’s sterile injectable drug product formulation and clinical stage manufacturing services include:

Pre-formulation, Formulation & Process Development

  • Analytical development
  • Development of liquid and lyophilized formulations of small organics, peptides, proteins and nucleotides
  • Solubility, stability enhancement (liquid or lyophilized)
  • Proof of concept stability
  • Assessment of solution stability in infusion system

Manufacture of Sterile Products for Clinical Trials

  • Small batch GMP aseptic production, cytotoxic and non-cytotoxic
  • Batch sizes 2,000 – 10,000 units
  • Primary packaging (mainly vials)
  • Liquid and lyophilized fill
  • Stand-alone client-provided formulation or continuation of development

Analytical & Ancillary Services

  • GMP product release testing
  • GMP product stability
  • Clinical QP release – finished drug product
  • Quality Assurance support and consulting
  • Labelling/packaging and storage/distribution