Proteins are biotechnology’s raw crude. For much of its 30-year history, the industry has struggled to come up with a steady source of supply, squeezing the maximum out of these large-molecule commodities from cell lines isolated from hamster ovaries and the like. In the late 1990s–with the advent of a new class of protein-based drugs, monoclonal antibodies–demand sometimes outstripped supply. For decades, the scientists who created recombinant erythropoietin to rejuvenate red blood cells and monoclonal antibodies to combat cancer have sought out alternative forms of manufacture.
A new bioreactor–an animal genetically engineered to produce a therapeutic protein in its milk–may finally be ready to fulfill its long-awaited promise. The European Medicines Evaluation Agency (EMEA) may decide early next year on approval of an anticoagulant protein, human antithrombin, that is produced in goat’s milk to treat a hereditary disorder. If the drug, ATryn, finally gets a nod from regulators, its approval will mark the culmination of a meandering 15-year journey for GTC Bio-ther-apeutics, a Framingham, Mass., spin-off of the biotech giant Genzyme.
A new bioreactor–an animal genetically engineered to produce a therapeutic protein in its milk–may finally be ready to fulfill its long-awaited promise. The European Medicines Evaluation Agency (EMEA) may decide early next year on approval of an anticoagulant protein, human antithrombin, that is produced in goat’s milk to treat a hereditary disorder. If the drug, ATryn, finally gets a nod from regulators, its approval will mark the culmination of a meandering 15-year journey for GTC Bio-ther-apeutics, a Framingham, Mass., spin-off of the biotech giant Genzyme.
