Isogen launches first phase of sterile contract facility

Isogen, a US contract development and manufacturing organization for sterile filling, has announced the first phase launch of its contract facility in Delaware. The firm says it was founded to specifically address the process, facility and capacity problems commonly associated with the $2.0-billion highly-niched, low-volume clinical and early-stage commercial sterile filling market segment.

Companies can invest over $100.0 million and four years to develop sterile manufacturing capacity, but are highly reluctant to take this initiative until they are certain the candidate drug will receive regulatory approval. Isogen's Phase I facility will accommodate Good Manufacturing Practice 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. Isolator-based lyophilization capacity is planned for later in 2009. The January 21, 2009, facility launch sets a new industry standard for GMP-compliant clinical manufacturing and containment, enabling Isogen's 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 dramatically reducing costs and risks that are inherently associated with other in-house and out-sourced alternatives, the firm claims.