Biologics Quality Control: The Growing Need for Accessible Proteomics.

QUALITY assurance standards; INVESTIGATIONAL drugs; BIOLOGICAL products; INFORMATION resources; MONOCLONAL antibodies; PROTEOMICS; MASS spectrometry

The article delves into the critical role of proteomics in drug discovery and development, emphasizing the necessity of understanding proteins at the single amino acid level. It highlights how variations, such as post-translational modifications, can significantly impact the function, stability, and safety of biologic drugs, necessitating precise analytical techniques throughout the therapeutic lifecycle.