Albany Molecular Research Inc

April 5, 2015

Pharmaceutical Technology Europe

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.

 

Email: Kristin.Calloway@amriglobal.com

 

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