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Companies can invest over $100 million and four years to develop sterilemanufacturing capacity, but are highly reluctant to take this initiative untilthey are certain the candidate drug will receive regulatory approval. Isogen'sPhase I facility will accommodate GMP vial and syringe filling, ranging infill size up to 4,000 units per shift in fully segregated, isolator-based filllines in a potent capable facility. Isolator-based lyophilization capacity isplanned for later in 2009. The January 21st facility launch sets a newindustry standard for GMP compliant clinical manufacturing and containment,enabling Isogen's customers to plan and execute the supply of integratedsterile clinical and small scale commercial launches of single or multipletherapeutics at the same time while dramatically reducing costs and risks thatare inherently associated with other in-house and outsourced alternatives.
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"Isogen's facility launch will help our customers address major industrydynamics that are reshaping the face and complexity of sterile clinical trialsmaterials supply," said Les Edwards, CEO, Isogen. "Regulators in the U.S. andEurope increasingly require sterile clinical trials supplies to bemanufactured in accordance with current Good Manufacturing Practice (cGMP)standards. At the same time many new pipeline drugs moving into clinicaltrials require Isogen's unique barrier isolation containment technology. Ourprocess ensures safe manufacturing, while meeting strict global regulatorystandards," Edwards concluded.
Isogen will offer an integrated GMP clinical and early commercial contractfilling service comprising sterile process development, analytical laboratoryservices and pharmaceutical engineering consulting. Isogen's Advanced SterileFilling 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 analyticalpharmaceutical laboratory and engineering service functions make Isogen afully integrated Contract Development and Manufacturing Organization (CDMO)capable of supporting client contract from formulation to distribution.
About Isogen
Isogen is the leader in advanced sterile manufacturing for potent andnon-potent therapeutics for the critical clinical/commercial scalemanufacturing transition. Isogen provides a fully integrated suite of servicesincluding formulation, technology transfer and validation services for thecontract filling of liquids and lyophilized formulations for vaccines,monoclonal antibodies and other synthetic and biologically derivedtherapeutics. Isogen delivers critical full service resources topharmaceutical and biopharmaceutical manufacturers seeking solutions inadvanced sterile filling including clinical and transitional contract filling,formulation/validation based analytical laboratory services and advancedsterile fill line/equipment design and GMP project management. For moreinformation, contact Joe Romano, Partner, HighGround at +1-781-939-5800 x 208or [email protected]
SOURCE Isogen
