NEWARK, DE--(Marketwire - July 27, 2009) - Isogen LLC, announced today that its Science Center, a new 20,000 square foot, state-of-the art, contract aseptic filling and manufacturing facility, located in Newark, Delaware, has successfully completed its media fills and has begun fulfilling a backlog of customer orders to big, medium and small/virtual pharmaceutical and biopharmaceutical companies. The completion of media fills is a mandatory, three step process that tests a facility’s equipment, processes and procedures to ensure product and deliverables meet quality standards. Successfully completing media fills is a major milestone for new pharmaceutical manufacturing facilities.
“We’re excited to have completed our media fills and to be filling product for our customers! We are providing something very unique to our industry -- the ability to develop life-saving therapeutics more effectively and affordably within an environment that utilizes the latest technology and adheres to the highest global manufacturing standards,” shared Les Edwards, Isogen CEO.
Isogen was launched to address the process, facility and capacity problems commonly associated with the $2 billion highly-niched, low-volume clinical and early-stage commercial, sterile, global filling market. Isogen offers a unique option to pharmaceutical and biopharmaceutical companies who are hesitant to invest over $100 million and four years to develop manufacturing capability prior to receiving regulatory approval. The Isogen Science Center helps bring novel and orphan drugs, many of which are life-enhancing and life-saving, to market faster.
“It is a tribute to the unrivaled dedication, hard work, and technical expertise of the Isogen team that our facility was conceived, launched and has begun delivering product to customers in just one year. That is a phenomenal accomplishment, perhaps unprecedented in our industry, and clearly, an indication of what the Isogen team can do for its customers and this market place,” commented Austin McDonald, COO of Isogen.
Due to the combined experience of the Isogen team in deploying advanced technologies and starting up sterile processing facilities, The Isogen Science Center was built at a fraction of the time and cost it historically takes a pharmaceutical company to build a facility. The Center meets global manufacturing standards -- US, EU and Japan -- and was designed by the Isogen Engineering Team, along with Precis Engineering and in collaboration with Cyma Builders and AES Clean Technologies.
About Isogen
Isogen provides advanced sterile manufacturing for potent and non-potent therapeutics for the critical clinical/commercial scale manufacturing transition. The Company delivers a fully integrated suite of services including formulation, tech transfer, laboratory and validation services for the contract filling of liquids and lyophilized formulations for vaccines, mAbs, and other synthetic and biologically derived therapeutics. For further information, contact Robin Uhl, ruhl@isogenllc.com, 201.394.1927.
Information contained in this press release, other than historical information, may be considered forward-looking in nature as such it is based upon certain assumptions and is subject to various risks and uncertainties, which may not be controllable by the Company. To the extent that these assumptions prove to be incorrect, or should any of these risks or uncertainties materialize, the actual results may vary materially from those that were anticipated.
CONTACT:
Robin Uhl
Isogen
201.394.1927
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