QSV Biologics, Ltd. and Critical Biologics Corp. Sign 2nd Contract for cGMP Manufacture of Plasma Gelsolin



    EDMONTON, Aug. 13 /CNW/ - 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 second, repeat business, contract for the
cGMP manufacturing of recombinant human plasma gelsolin (Solinex(TM)) being
targeted for various critical care applications and end-stage renal disease
patients on dialysis. QSV will be responsible for process development and cGMP
manufacture of phase I/II clinical trial material in its commercially licensed
cGMP manufacturing facility.
    Plasma gelsolin (pGSN) is a naturally occurring, and highly evolutionary
conserved, circulating plasma protein involved in the regulation and
localization of inflammation. Severe depletion of plasma gelsolin has been
found to correlate strongly with increased morbidity and mortality in a number
of acute and chronic diseases. Experiments in animal models have shown that
disease progression and adverse outcomes can be averted by a timely
replenishment of plasma gelsolin using Solinex(TM). CBC is currently
completing a Phase 2a placebo controlled safety and pharmacokinetic trial of
Solinex(TM) in critical care patients identified as being at high-risk of
developing sepsis using CBC's proprietary pGSN diagnostic assay, SolinDx(TM).
    Ashleigh Palmer, CBC's President and Chief Executive Officer, indicated
that, after a successful first contract with QSV Biologics, signed in January
2007, his company's requirement for larger quantities of Solinex(TM)
necessitated a detailed re-evaluation of the available options, including
possibly switching to a CMO with larger capacity fermenters in the 5,000 -
10,000L range. However, Mr. Palmer said he was delighted to announce that:
"having successfully collaborated with QSV's highly capable scientific team to
demonstrate the viability of a newly designed higher-yield clone, I am very
pleased to announce that we have decided to continue our partnership with, and
award the contract to, QSV Biologics".
    Graeme Macaloney PhD, PEng, QSV President & CEO stated: "This has been a
tremendous opportunity to demonstrate the ability of our world class team and
facility. It is an excellent example of how increased process productivity can
shrink the required scale of fermentation. We are delighted to provide the
expanded manufacturing capacity for Solinex(TM), an important
development-stage biologic, and look forward to a long and mutually beneficial
partnership with CBC, potentially through Phase 3 clinical development and
commercial manufacture".

    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 the development of a theranostic platform to screen and
treat both acute and chronic patients with low plasma gelsolin levels
(hypogelsolinemia) at high risk of life-threatening complications.

    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 12 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 and
the BioAlberta "Company of the Year Award" in 2007. QSV's global clientele
spans 3 continents and develops 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:

For further information: Richard Hetrick, M.Sc., B.Sc., Director
Business Development, QSV Biologics, Ltd.; QSV Biologics Ltd, 9411-20th Ave.,
Edmonton Research Park, Edmonton, Alberta, T6N 1E5, Phone: (780) 438-5722,
Fax: (780) 434-0838, E-mail: RHetrick@QSVBiologics.com

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QSV BIOLOGICS, LTD.

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