Avid Bioservices is a wholly owned subsidiary of Peregrine Pharmaceuticals Inc. Avid Bioservices has signed a manufacturing supply agreement with Catalyst Biosciences, Inc. to produce clinical-grade material in support of their clinical candidate, CB 813, an improved version of factor VIIa for the treatment of acute bleeding in hemophilia patients.
Hemophilia is a hereditary disorder that affects approximately one in 5,000 males born in the United States. When a person with hemophilia is injured, he does not bleed harder or faster than a person without hemophilia, he bleeds longer. Small cuts or surface bruises are usually not a problem, but more traumatic injuries may result in serious problems and potential disability. Deep cuts or internal bleeding, such as bleeding into the joints or muscles, require more complex treatment. The clotting factor missing (VIII or IX) must be replaced so individual can form a clot to stop the bleeding.
Under the terms of the agreement with Catalyst Biosciences, Avid Bioservices will begin manufacturing drug supply under current good manufacturing practice (cGMP) regulations and provide cell bank preparation, process development, and preparation of the manufacturing portion of the FDA Investigational New Drug Application.
“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, Ph.D., CEO of Catalyst Biosciences.
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