Almac Invests in Highly Potent API and Formulation Services

InformexUSA, San Francisco (Feb. 14)-Almac Sciences (Craigavon, Northern Ireland, www.almacgroup.com) plans to collaborate for cytotoxic fill-and-finish services with the Center for Pharmaceutical Science and Technology (CPST) at the University of Kentucky (Lexington, KY, www.uky.edu).

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 sterile manufacturing facility at the University’s Coldstream Research Campus near Lexington. The $17-million facility 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 in-house process research, development, manufacturing, and logistics capability at its Craigavon, Northern Ireland complex. Almac Sciences manufactures cytotoxic APIs in dedicated facilities.   

At InformexUSA, Almac Sciences also announced that its manufacturing site for highly potent compounds in Craigavon earned certification under the “SafeBridge” program, a review and certification program conducted by SafeBridge Consultants, Inc. (Mountain View, CA). SafeBridge conducted a 60-element review of programs, procedures, and containment of the active pharmaceutical ingredient synthesis areas at the site, and based on the quantitative results of the Potent Compound Safety Certification program, SafeBridge certifies that Almac meets current industry standards for the safe handling of potent active pharmaceutical ingredients in certain areas of its plants dedicated to handling such materials.

CPST is a fully integrated FDA-registered analytical and formulation development and pharmaceutical clinical supplies CGMP manufacture facility. It has the capacity to develop and manufacture semi-solid dosage forms and solutions through early Phase II clinical trials. By 2011, the Coldstream facility is projected to have revenues of $15 million with a science-based staff of 50.

Almac offers contract manufacturing for cytotoxic and potent active pharmaceutical ingredients, peptides, chiral compounds, and radiolabelling. In 2006, it launched carbon 14-radiolabelling services and commissioned a $1 million package of new assets at its Northern Ireland and Scottish sites for enhanced multi-kilo GMP production of peptides.