New Isogen facility to address global biopharma demand
A leading US contract developer and manufacturer for sterile filling is to unveil the first phase of its latest facility in Delaware, US early next year.
The new Isogen facility which is to be launched officially on 21 January, 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 lyophilisation capacity is planned for later in 2009.
Isogen claim that the facility 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 Isogen ceo Les Edwards. ‘Regulators in the US 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 aims to offer an integrated GMP clinical and early commercial contract filling service comprising sterile process development