Albany Molecular Research Inc

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.

Email: Kristin.Calloway@amriglobal.com

Click here for more information about our Drug Product services.