Protecting Patients from Prions
We must ensure that biological products are free from contamination – or we risk transmission of a fatal disease to a patient
Aaron Schieving | | Opinion
With the evolution of science, the world is increasingly benefiting from the amazing lifesaving and life-enhancing medical products developed and commercialized today. As new drugs, biologics, and devices come to market, the regulatory landscape evolves alongside them. Because these products are used on patients, it is critical to ensure they are safe – which can mean a number of different things, all of which should be built into the design of these products well before manufacturing begins. The companies developing these products devote significant care and attention to the products they make, but contamination can occur with any product at any time – even one manufactured under current Good Manufacturing Practice and a robust Quality Management System. Although this statement is true for all pharmaceutical products and medical devices, it is especially true for biologics, human cells, tissues, and cellular and tissue-based products (HCT/Ps) due to their sources and/or the addition of biologic components.
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