Phase III Clinical & Commercial cGMP Manufacturing Agreement Signed By Celtic Pharma And QSV Biologics, Ltd., For TransMID
QSV Biologics, Ltd (QSV), a North American based biologics CMO located in Edmonton, Canada, and Celtic Pharmaceutical Holdings L.P. (Celtic Pharma), a global private equity investment firm that invests in, and manages, late stage pharmaceutical programs, based in Bermuda, announced today the signing of a cGMP manufacturing agreement for TransMID. QSV will be responsible for cGMP manufacture of further phase III clinical trial material and longer term commercial manufacture in their licensed cGMP manufacturing facility. TransMID is being developed for the specific treatment of progressive and recurrent non-resectable glioblastoma multiforme, a particularly dangerous type of brain tumor where the average life expectancy is less than six months upon diagnosis.
Graeme Macaloney PhD, PEng, QSV President & CEO said: "Celtic Pharma play an important role in providing critical capital and management experience to late stage pharmaceuticals thereby accelerating their time to market and to patients in need. We are delighted to be able to provide Celtic with their clinical and longer term commercial manufacturing requirements."
Michael Earl, Celtic Pharma's Managing Director, Commercial commented: "TransMID is an innovative product for Celtic Pharma for which we had to secure ultimate commercial manufacture with a high quality cGMP manufacturer. QSV Biologics, with their commercial Establishment License, excellent track record, and outstanding team provided us with the best option for this valuable and much needed treatment."
Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global private equity investment firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen EvansFreke and John Mayo CBE and is based in Bermuda, with offices in New York and London. Celtic Pharma acquires and invests in late stage pharmaceutical programmes and manages these programmes through to regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought. For further information, please visit Celtic Pharma's Web site at www.celticpharma.com.
QSV Biologics, Ltd., 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 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 more info., please see: www.qsvbiologics.com.
QSV Biologics, Ltd.