miércoles, 3 de abril de 2019

Science & Research (Drugs) > Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics

Science & Research (Drugs) > Impact Story: Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of Complex Therapeutics





CDER researchers are evaluating an approach that would harness the potential of mass spectrometry to ensure the quality of complex protein therapeutics to treat cancer and other diseases. Mass spectrometry is a technology that can give manufacturers and regulators more detailed information about the critical quality attributes of complex products. CDER’s evaluation of this approach is intended to help manufacturers apply this tool toward improved quality control of protein products, including therapeutics for cancer.

To learn more, please visit: FDA CDER Impact Story.

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