Contract manufacturing news in brief
have all recently announced new contract manufacturing news.
It has just been announced that Pfizer has awarded Canada's QSV Biologics a cGMP manufacturing contract for the clinical trials material production of a recombinant protein that it has under development. The protein will be manufactured at QSV's Edmonton facility and work on the project is to begin immediately, and will include technology transfer, scale-up and cGMP manufacturing. No other terms of the deal were disclosed. Rick Rutter, vice president of global biologics in the Pharmaceutical Sciences division of Pfizer Global Research and Development said: "Speed to clinic is of great importance for early development candidates and QSV has a record of delivering quality product on-time and on-budget." "QSV will play a supporting role in realizing Pfizer's vision of becoming a top tier biotherapeutic company." Meanwhile, biopharmaceutical manufacturer SynCo Bio Partners has signed a master services agreement with OncoMed Pharmaceuticals, a company developing novel therapeutics that target cancer stem cells. Under the arrangement, from its Amsterdam-based facility, SynCo will fill and finish batches of OncoMed's lead product, antibody OMP-21M18, for use in Phase I clinical trials. The monoclonal antibody is scheduled to enter the clinic in 2008. Paul Hastings, president and CEO of OncoMed, said: "We selected SynCo Bio Partners because we needed a GMP-accredited contract manufacturing organisation that had a proven track record in filling biologics." "With SynCo's expertise in all aspects of biopharmaceutical manufacture, they were an ideal partner for us at this crucial stage in our development." In other related news, the American Peptide Company (APC) recently announced its new 'Total Peptide Management' programme, which it is calling "the first of its kind". Under the programme, the company said it now offers the life sciences industry "a broad portfolio of peptides, value-added services, and expert consultation to support customer needs as their drug products move from discovery to development and commercialisation." Specifically, the firm said its customised service platform comprises of process development; scale-up production; analytical and process validation; stability studies; chemistry, manufacturing, and controls (CMC); drug master files (DMF) and regulatory support to "provide customers with efficient, high-quality and cost-effective peptide management solutions." As part of the program, APC said it also provides "innovative peptides in a timely and cost-effective manner" to drug manufacturers. "The high-quality of these peptides helps manufacturers realise improved consistency, with higher yields and reliable product quality. This helps companies looking to commercialise their product significantly reduce their total operations cost, as well as speed time to market," the firm said.
