Summary

Contract Research, Development and Manufacturing Services.

Profile

Albany Molecular Research, Inc (AMRI) is a global contract research and manufacturing organisation offering customers fully integrated drug discovery, development and manufacturing services. For more than 21 years AMRI has demonstrated its adaptability as the pharmaceutical and biotechnology industries have undergone tremendous change in response to multiple challenges.

SMARTSOURCING, a full range of value-added opportunities provides customers with informed decision-making, enhanced efficiency and more successful outcomes at all stages of the pipeline.

Major Products/Services

Contract Research/Discovery

AMRI’s integrated approach to drug discovery and development, includes capabilities in the areas of in vitro biology, in vitro pharmacology, DMPK, medicinal chemistry, computer-aided drug discovery (CADD) and structural biology and screening. The company applies medicinal chemistry to modify the structure of a hit compound, or series of hit compounds, to synthesise new molecules with the end goal of discovering compounds that are suitable for progressing into the human clinical trials phase. AMRI’s biology capabilities, which easily integrate with its chemistry services, include target and biomarker validation; assay development and design; in vitro pharmacology, such as potency, selectivity and mechanism-of-action studies; high-throughput screening (HTS); chemical genomics; in vitro DMPK; in vivo DMPK and in vivo pharmacology.

Development

AMRI SMARTSOURCING provides state-of-the-art facilities and capabilities to deliver integrated pharmaceutical drug development programmes through the clinic to commercial. AMRI’s Pre-Formulation Development, Formulation Services & CTM, Process Development and Analytical Services are available for a variety of dosage forms, from Powder-in-a-Bottle (PIB) and capsules to advanced oral, topical and sterile formulations. The company also has the capabilities required to provide a reliable and cost-effective supply of drug product through commercial production, as well as API from pre-clinical to post- NDA commercial production.

Contract Manufacturing

AMRI’s worldwide manufacturing facilities are equipped for Phase I through commercial API manufacturing and AMRI SMARTSOURCING provides an added advantage as customers move their compound from discovery to high potency manufacturing. AMRI’s global sites are positioned to provide tailored solutions and to enable the efficient, cost-effective transfer of pre-clinical and commercial drug products – from small-scale to large-scale production. AMRI can provide raw materials, starting materials and cGMP manufacturing of API.

Aseptic Fill and Finish

In the company’s state-of-the art cGMP manufacturing facility, in Burlington, Mass., AMRI offers customers aseptic processing services, including aseptic filling of syringes, vials and other custom containers; lyophilisation; and the very latest in Stability Optimisation Services (SOS). AMRI supports clients from pre-clinical stages of development through cGMP clinical and commercial scale production of liquid-filled parenterals.

Major Markets

AMRI works with large global and small-to medium- size biotech/specialty pharmaceutical companies, and government and nonprofit organisations.

For European enquiries:

European Headquarters:

Mostyn Road

Holywell, Flintshire, Wales

United Kingdom CH8 9DN

T: +44 (0)1352-717114

E: Gareth.Jenkins@amriglobal.com

For US enquiries:

Global Headquarters:

26 Corporate Circle

Albany, NY USA 12203

T: +1 518 512 2345

F: +1 518 512 2020

E: James.Grabowski@amriglobal.com

For Asia enquiries:

Global Headquarters:

26 Corporate Circle

Albany, NY USA 12203

T: +1 518 512 2345

F: +1 518 512 2020

E: Takahiro.Kuno@amriglobal.com

E: Max.Rossetto@amriglobal.com