Avid Bioservices, Inc., announced that it has signed a manufacturing supply agreement with San Francisco, CA-based Catalyst Biosciences, Inc., to produce “clinical-grade material” for production of a new factor VIIa product. The drug candidate, called CB 813, is being positioned by Catalyst as an improved version of factor VIIa for the treatment of acute bleeding in hemophilia patients. According to the manufacturers, among CB 813’s advantages is its greater potency.
CB 813 is being developed using Alterase™, Catalyst’s patented protease technology. Proteases, enzymes that cause the hydrolytic breakdown of proteins into peptides or amino acids, are often used as therapeutics for several diseases, including age-related macular degeneration, cancer and hemophilia. CB 813 boosts clot-generating activity at the bleeding site, achieving “clinical efficacy” with fewer and lower doses than existing therapies.
Under the terms of the agreement, Avid Bioservices, headquartered in Tustin, CA, will begin manufacturing drug supply under current good manufacturing practice regulations and provide cell bank preparation, process development and preparation of the manufacturing portion of the Investigational New Drug application filed by Catalyst with the U.S. Food and Drug Administration.
“Avid’s expertise in the scale-up and manufacture of clinical-grade biotechnology therapeutics and their strong customer orientation made them a good choice for Catalyst,” said Nassim Usman, PhD, CEO of Catalyst Biosciences.
In 2002 Avid Bioservices® was established as a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc.
Source: Peregrine Pharmaceuticals news release dated October 27, 2008