Diane M. Diehl | Authors

Mass spectrometry (MS) is emerging as a critical tool in biopharmaceutical late stage development, manufacturing, and quality control (QC) environments. The rapid growth of biologics in development, the increasing demand for more robust analytical technologies to directly monitor the critical quality attributes (CQAs) of these new drugs, and longer term industry initiatives aimed at improving quality and productivity, such as quality by design (QbD) regulatory submissions and continuous manufacturing, are all fueling a greater need for mass monitoring with MS.

Fast, flexible platforms for peptide quantification are needed, particularly for a discovery setting. This type of methodology would be especially advantageous in the case of amyloid beta (a?) peptides.

The growing market for biotherapeutic peptides and the development of quantitative methods for those analytes has brought to light the challenges facing the analysis of this broad range of compounds. Market forces and regulatory requirements are encouraging analytical groups to develop methodologies that are time- and cost-effective, while still producing assays that are sensitive enough to cope with biological matrices.

Waters Application Note

Streamlined sample prep, LC and MS method development.

Streamlined sample prep, LC and MS method development.