Isogen has made the first phase launch of its contract aseptic manufacturing facility in Delaware. 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 lyo-capacity is planned for later in 2009.
The company contends that its 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 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, Isogen's chief executive officer. "Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies to be manufactured in accordance with cGMP standards. At the same time many new pipeline drugs moving into clinical trials require unique barrier isolation containment technology. Our process ensures safe manufacturing, while meeting strict global regulatory standards."
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, the company assures.
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