Abstract
Since the introduction of Quality by Design for production of biopharmaceuticals, the global biopharma industry has been advancing towards developing highly efficient and sensitive platforms for monitoring product quality attributes. Incorporating mass-spectrometry-based multi-attribute monitoring (MAM) as a novel tool for identifying and characterizing post-translational modifications in biotherapeutics has gained increasing traction. The ability of MAM to monitor multiple critical quality attributes coupled with new peak detection functions in a single workflow is highly desirable to the biopharmaceutical industry. This review examines and discusses the evolution and adaptation of MAM for routine product quality assessment. MAM applications in biotherapeutic characterization, comparability, and chemometrics have also been discussed, along with the gaps and future perspectives of the MAM implementation in biopharmaceutical drug development. Primary focus has been kept on major developments in last 6 years (2018–2024).
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callSimilar Papers
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
