Isogen, a contract development and manufacturing organization for sterile filling, is launching its new facility in Delaware on January 21. The company will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical lab services and pharmaceutical engineering consulting. The Phase I facility will accommodate GMP vial and syringe filling, ranging in fill size up to 4,000 units per shift in fully segregated, isolator-based fill lines in a potent capable facility. The company plans to add to its isolator-based lyophilization capacity later in 2009. According to the company, the facility will enable customers to plan and execute the supply of integrated sterile clinical and small scale commercial launches of single or multiple therapeutics at the same time, while reducing costs and risks associated with other in-house and outsourced alternatives.
“Isogen’s facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply,” said Les Edwards, chief executive officer, Isogen. “Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with current Good Manufacturing Practice (cGMP) standards. At the same time many new pipeline drugs moving into clinical trials require Isogen’s unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards,” Mr. Edwards concluded.