Through our Science Center in Newark, Delaware, Isogen provides isolator-based advanced sterile manufacturing for potent and non-potent therapeutics for the critical clinical/commercial scale manufacturing transition. We provide a fully integrated suite of services including formulation, technology transfer and validation services for the contract filling of liquids and lyophilized formulation for vaccines, mAbs, and other synthetic and biologically derived therapeutics.
Isogen's Mission is to improve product quality and speed product to market, while enhancing process robustness, scalability and economics. Our Vision is to be recognized as the industry partner of choice for the outsourcing of sterile filling from clinical through early stage commercial manufacturing.
Isogen's business philosophy is simple: full transparency. To our customers, Isogen offers open access to all data, while respecting specific client confidentiality. We also encourage our clients to work collaboratively, welcoming the ‘person-in-the-plant' client presence during testing and manufacturing operations. If future scale up is required, our clients receive access to the Science Center and process equipment designs, specifications and procedures as well as Isogen's experience!
Isogen serves pharmaceutical companies of all sizes, large, medium and small/virtual, through our three service lines: (1) contract filling, (2) pharmaceutical sciences, and (3) process consultancy. Isogen's experienced staff provides GMP Clinical Filling… the way it should be!
Isogen's facilities have been designed with two requirements in mind:
Multiproduct capability for the handling of most types of potent and nonpotent therapeutics including live virus, cytotoxics etc., through the integration of single use fluid paths with advanced isolation and containment technology. A 'speed-to-market' machine. We're setting the bar high, but we believe that's what you would do if you were building from the ground up.
Our business philosophy is simple: full transparency. Our partners will receive open access to all data, while respecting specific client confidentiality, as well as what we call our 'man-in-the-plant' policy. If future scale up is required our clients will have open access to our facility and process equipment designs, specifications and SOP's as well as our experience!
Now is the time to plan for the future –
Join us as a primary partner and integrate your company's best practices with ours. Find out how the Isogen Engine delivers the highest quality aseptic manufacturing while delivering a real ROI.
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