Emerging Technology as a Key Enabler for Modernizing Pharmaceutical Manufacturing

摘要

A high-quality drug is generally considered one that is free of contamination and that reliably delivers to the patient the therapeutic benefit as promised on the product label. When patients go to a local pharmacy, they do not inspect individual pills or vials to select the highest quality medicines, like they might do when buying products at the supermarket. Patients implicitly expect the medicine to be of high quality and that it will perform as indicated on the product label every time they take it. Today's medicines are often the result of intense, cutting-edge basic and clinical research. But alarmingly, drug development globally has tended not to resource the same laboratory-based research and development intensity into pharmaceutical/biopharma-ceutical manufacturing as has been placed on drug research and discovery. The manufacture and testing of medicines continues to rely too often on decade(s)-old technologies. Many of the problems that we have seen in drug quality in recent years, including high rates of drug product recalls and shortages, reflect the use of antiquated manufacturing designs and processes. American patients, who face life-threatening conditions such as cancer, infectious disease, and metabolic disorders, suffer enormously when adequate medication runs in short supply.