ISOGEN mission is to enhance sterile filling technology and practices for “Transitional Scale” operations improving product quality, speed-to-market, as well as process robustness, scalability and economics.

We will be recognized as the industry “Partner of Choice” for the outsourcing of transitional sterile filling from clinical through early stage commercial by:

• Seamlessly integrating all pertinent analytical, tech transfer, and validation services
• Enabling the use of universal manufacturing platforms, quality and validation standards across every clinical phase and
• Delivering the best outsource partner value.

ISOGEN has entered the detailed design phase of an advanced aseptic manufacturing facility. We call it the ‘Engine’ – and it will be online early in 2010.

It is designed for two requirements:

• 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 path 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.