QSV Biologics, Ltd., and Critical Biologics Corp., Sign Contract for cGMP Manufacture of Gelsolin for Critical Care Applications

Announced today the signing of a contract for the cGMP manufacturing of recombinant human plasma gelsolin (rhu-pGSN) targeted for the prevention of life-threatening critical care complications associated with low plasma gelsolin levels.

EDMONTON, Canada | Feb 12, 2007 |
QSV Biologics, Ltd (QSV), a North American based biologics CMO located in Edmonton, Canada, and Critical Biologics Corp., (CBC) a privately held, biotechnology company located in Cambridge, MA, U.S.A., announced today the signing of a contract for the cGMP manufacturing of recombinant human plasma gelsolin (rhu-pGSN) targeted for the prevention of life-threatening critical care complications associated with low plasma gelsolin levels. QSV will be responsible for technology transfer and cGMP manufacture of phase I/II clinical trial material in their licensed cGMP manufacturing facility.

Gelsolin is a naturally occurring protein found inside cells as well as in the plasma. Circulating plasma gelsolin levels decrease shortly after a variety of tissue injuries such as trauma, major surgery, burns and sepsis.

Severe depletion of plasma gelsolin has been found to correlate strongly with adverse clinical outcomes in critical care patients such as longer ventilator times, longer duration of ICU stays and death. Experiments in animal models have shown that disease progression and adverse outcomes can be averted by a timely replenishment of plasma gelsolin using rhu-pGSN. It is therefore anticipated that, in high-risk critical care patients, the early detection of reduced plasma gelsolin levels followed by replacement with rhu-pGSN could provide an efficacious and well tolerated therapeutic intervention.

Graeme Macaloney PhD, PEng, QSV President & CEO said: "This is a fascinating theranostic approach that combines drug treatment with a diagnostic product that should result in an effective targeted therapy for the prevention of a range of medically important critical care conditions. We are excited to be providing the manufacture of this important development-stage biologic".

CBC's CEO, Ashleigh Palmer, commented: "We are delighted that QSV has agreed to be CBC's manufacturing partner as our rhu-pGSN program enters the clinical stages of development. The decision to partner with QSV has come after a careful review and evaluation of available alternatives, and the client service philosophy underpinning QSV's strategic intent has been an especially important consideration in our selection process."

Critical Biologics Corp. was founded in 2006 with a strategic intent to develop and commercialize diagnostics and therapeutics that predict and regulate inflammatory responses to life-threatening diseases. In particular, CBC is focused on a theranostic approach to treat critical care patients with low plasma gelsolin levels at high risk of life-threatening complications.

Gelsolin was first discovered by Dr. Thomas P. Stossel, American Cancer Society Professor of Medicine at Harvard Medical School and Director of the Translational Medicine Division and Senior Physician in the Hematology Division at Brigham & Women's Hospital. In October 2006, CBC entered into an agreement with Brigham & Women's Hospital to license technology and intellectual property pertaining to the therapeutic and diagnostic use of plasma gelsolin to predict and pre-emptively treat a variety of medically and economically important conditions.

QSV Biologics, Ltd. (www.qsvbiologics.com), is an international cGMP biologics contract manufacturer (CMO) providing microbial fermentation & cell culture, and purification services. QSV's facility has a 10 yr track-record including an Establishment License for manufacturing clinical trial and commercial biologics. QSV was the sole recipient of the prestigious international Frost & Sullivan "Customer Value Enhancement Award" in 2005.

QSV's clientele span three continents and develop protein therapeutics, vaccines & diagnostics. As a dedicated CMO with no competing products of its own, QSV builds value for its clients by producing quality products in a timely manner. Hence its acronym: QSV: Quality & Speed build Value.


For further information: Richard Hetrick, M.Sc., B.Sc., Director of
Business Development, QSV Biologics, Ltd., Ph: (780) 438-5722 Ext. 1, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.; Ashleigh Palmer, Chief Executive Officer, Critical Biologics Corp., Ph: (908) 439-9768, Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

SOURCE: QSV Biologics, Ltd

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