Canadian contract manufacturing organisation (CMO) QSV has signed a deal with US-based biotech firm Critical Biologics for the manufacturing of a new drug aimed at preventing complications associated with low levels of plasma gelsolin, a protein that responds to injured tissue.
Under the terms of the agreement, QSV will be responsible for technology transfer and Phase I and II clinical trial material supply of the recombinant human plasma gelsolin (rhu-pGSN).
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.
Previously conducted research suggests 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.
"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," said Graeme Macaloney, QSV's CEO.
"We are excited to be providing the manufacture of this important development-stage biologic."
Critical Biologics said 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."
Meanwhile, Avexa and Novasep have also penned a manufacturing deal for the clinical supply of Avexa's new drug for the treatment of HIV.
The agreement covers the production and scale-up of the active pharmaceutical ingredient (API) of the new apricitabine (ATC) drug – a nucleoside reverse transcriptase inhibitor (NRTI) – for use in Phase III trials and in preparation for the commercial launch of the product.
"Novasep is a well established company with extensive experience in the chemical processes required for ATC production," said Dr Julian Chick, CEO of Avexa.
"The signing of this agreement signals yet another step forward in the progression of apricitabine towards the market."
ATC is currently in Phase IIb clinical trials. Recruitment for the study was completed at the end of 2006 and the results are due in the first quarter of 2007.
In other contract manufacturing news, US-based Hyaluron has announced it plans to expand its Massachusetts facility thanks to a $1m loan the company has been granted.
The CMO said it will use the low interest loan to expand clean room and manufacturing space at its Burlington headquarters.
Half of the loan comes from a direct investment from a bank while the remaining is lent by the state of Massachusetts' finance and development arm.
Hyaluron expects to create 30 new high-tech manufacturing jobs in the year following the completion of the build out in the second quarter of the year.
Finally, Cytovance has been picked by Bone Biologics to manufacture clinical quantities of its new recombinant protein for spinal fusion surgery.
Bone Biologic's new drug was developed with its protein-based technologies for bone and cartilage regeneration.
"We selected Cytovance as our manufacturing partner after an exhaustive industry search and qualification process," said Bruce Hazuka, chief executive officer of Bone Biologics.
"Cytovance earned our business by providing a unique blend of technical expertise, responsiveness and operational flexibility that will facilitate the rapid development of our platform technology into phase I clinical trials for our initial market focus of bone regeneration."
The manufacturing will be conducted at Cytovance's 44,000 sq. ft. Oklahoma City facility.
Cytovance specialises in clinical manufacture of antibody and recombinant protein products derived from cell culture at scales up to 500L (w/v) from both fed-batch and perfusion processes.
