Isogen, a contract development and manufacturing organization for sterile filling, has announced the first phase launch of its contract facility in Delaware. Isogen was founded to specifically address the process, facility and capacity problems commonly associated with the $2 billion highly-niched, low-volume clinical and early-stage commercial sterile filling market segment. Companies can invest over $100 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 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. Isolator-based lyophilization capacity is planned for later in 2009. The January 21st 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 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, CEO, 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,” Edwards concluded. Isogen will offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development, analytical laboratory services and pharmaceutical engineering consulting. Isogen’s Advanced Sterile Filling offers full product segregation and isolator-based sterile processing. The facility meets global regulatory standards and operates according to cGMP. Isogen’s industry subject matter experts and a combination of its analytical pharmaceutical laboratory and engineering service functions make Isogen a fully integrated Contract Development and Manufacturing Organization (CDMO) capable of supporting client contract from formulation to distribution.
