Albany Molecular Research Inc
AMRI Glasgow Ltd. is located in the United Kingdom. The site provides pre-formulation, formulation and process development services, as well as manufacture of sterile products for clinical trials
AMRI Glasgow Ltd., which is located in the United Kingdom, provides pre-formulation, formulation and process development services, as well as manufacture of sterile products for clinical trials. The site, which complements AMRI's front-end formulation expertise, 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
Contact Details:
Albany Molecular Research Inc.
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