CPST fill-and-finish agreement for Almac Sciences’ cytotoxics

 

CPST fill-and-finish agreement for Almac Sciences’ cytotoxics

Almac Sciences is to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology – CPST, at the University of Kentucky. Under an initial agreement, CPST will provide IV formulation and sterile fill of cytotoxics and potents for clinical trial applications.

The contract will be delivered through CPST’s newly commissioned, highly innovative sterile manufacturing facility at the University’s Coldstream Research Campus, near Lexington. The US $17m. facility officially opened in May 2006.

This non-exclusive agreement with CPST completes Almac Sciences’ supply chain solutions package in cytotoxics and potents, for which it already has significant in-house process research, development, manufacturing and logistics capability at its Craigavon, Northern Ireland complex.

CPST General Manager Joe Wyse, Ph.D commented: “CPST is delighted at these opportunities to add Almac Sciences to a distinguished roster of major pharma and bio services players that have seen our ability to add value to their programs – and to welcome them to our new Coldstream facility”.

Dr. David Moody, VP Commercial Operations for Almac Sciences, said: “Collaboration with CPST is an important link in completion of our supply chain in cytotoxics for clinical trial applications.

 

“This is another example of our commitment to specialized, interconnectable services that create powerful supply chain solutions. We will continue to meet our customers’ diverse and increasingly complex needs by combining Almac’s world class capabilities with the complementary services of other leading industry players”.

Almac Sciences’ business manager for cytotoxics programs, Dr Rosaleen McGuckin, added: “CPST’s facilities and track record are impressive. Their sterile fill capability complements our upstream service offer in cytotoxics – and promises to similarly meet our emerging requirement in formulation of cytotoxic peptide conjugates”.

 

Dr. McGuckin emphasized that connection with CPST would benefit customers by significantly complementing Almac Sciences’ solid-dosage formulation capabilities – and by adding to its menu of project management and supply chain services.

Almac Sciences manufactures cytotoxic APIs in dedicated facilities, which were expanded in 2003 following significant investment. Packaging, labeling and distribution services for clinical trial supplies are provided through sister division, Almac Clinical Services.

 

Additional CPST capabilities:

In addition to cytotoxic and potent API containment, CPST’s 20,000 sq. ft. Coldstream facility, with a current staff of 25, has capabilities in non-sterile liquids and suspensions, sterile liquids; lyophilized product filling; APIs; biologics and advanced formulations.

CPST is a fully integrated, FDA-registered analytical and formulation development and pharma clinical supplies cGMP manufacturing facility. It has the capacity to develop and manufacture semi-solid dosage forms and solutions for safety/toxicity studies and Phase I and early Phase II clinical studies. Customers include pharma companies, leading bio companies, academic institutions and US federal agencies.

 

By 2011, the Coldstream facility is projected to have annual revenues of US $15m. and be employing up to 50 science-based and other professional staff.

 

Almac service package:

 

Through contract R&D, custom manufacturing and analytical services, Almac Sciences has supported drug discovery, development and commercialization since 1992. The service package has been steadily developed to include speciality offerings in cytotoxic and potent manufacturing; peptides, protein and oligo synthesis, chirals and radiolabeling.

In 2006, the division – part of the Almac Group – launched Carbon 14 radiolabeling services, and commissioned a $1m. package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.

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Notes for Editors:

• Almac Sciences is part of the Almac Group, which comprises five closely integrated divisions offering a broad range of services from R&D, diagnostic/genomic services, API manufacture, formulation development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture.  Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.

 

• Almac Sciences operates from a £25m. 80,000 sq. ft. HQ and laboratory complex in Craigavon, Northern Ireland, with a production and R&D center near Edinburgh, Scotland.  The business has over 200 employees, including 120 scientists.

 

• Almac announced the re-branding of its five business divisions under the Almac brand name in mid-June 2006. Almac Group employs 2,000 people in Northern Ireland, Scotland, England and the USA. See almacgroup.com

 

• Founded in 1986, CPST has completed well over 200 projects and grants focused on analytical formulation development and manufacture of existing drugs and NCEs. In addition to the Coldstream facility, the headquarters in Lexington – located in the College of Pharmacy and part of the University of Kentucky – has nearly 5,000 sq. ft. of lab and manufacturing facilities. See: www.cpst.com

 

– ENDS –

For further information contact:

Dr. Rosaleen McGuckin                                                Roger Johnstone

VP Business Development – Almac Sciences                      Deben Editorial Services

Tel: +44 (0)28 3839 5830                                           Tel: +44 (0)161 614 1450

Mobile: +44 (0) 7803 830775                                          Mobile: +44 (0)7841 433141

Fax: +44 (0)28 3833 2299                                               Fax: +44 (0)161 614 1450

 

[email protected]                          [email protected]