How do biopharmaceuticals get from the laboratory to the patient?
Through basic research, translational research, highly regulated human testing, and manufacturing that meets rigorous FDA standards. Studies on how cells grow, divide, differentiate, communicate, and mutate are the foundation of discoveries that lead to biopharmaceutical drug development. Combining these studies with similar basic research on pathogenic organisms, our natural immune defenses, and many other important aspects of disease and immunity, provides the impetus for ideas on what kinds of therapies might work for different diseases. Once an idea is generated, the drug candidate is produced in the laboratory and tested for safety and efficacy. If the drug candidate proves to be safe and effective in the laboratory, it may advance to clinical trials using human volunteers. The drug development process can take many years and is expensive. The FDA will allow a drug to be produced for commercial distribution only when it meets stringent safety and efficacy requirements. Even after
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