Analytical data can be so much more than a historical point in time documented in a single report. In fact, biopharmaceutical organizations can use LC-MS data to build a continuum of compliance.
There are two primary multi-attribute monitoring (MAM) assay choices for biologic development and QC: subunit protein mass analysis and peptide mapping by LC-MS. Here we explore how peptide mapping LC-MS MAM workflows are being used.
Two MAM approaches for biotherapeutic analysis are being implemented today; one focused on the analysis of monoclonal antibody (mAb) subunits, and the other focused on the analysis of peptides from a protein digest (peptide mapping workflow). Both have their advantages and disadvantages. Here, we explore MAM for mAb subunit analysis.
A thousand small delays and opportunities for error can snowball over the years of a complex biotherapeutic drug development program. They add up to lost time and increased risk in an endeavor that has little tolerance for either. It doesn’t have to be this way.
To get the most out of recent innovations in biopharma development and QC such as multi-attribute monitoring, it’s time to better connect the systems that manage biopharma data. This series explores the what, the why, and the how of better biopharma data.
If data can throw your biotherapeutic development program into chaos, it can also help move you forward. Let’s see how.
As regulators focus in on the critical quality attributes of biotherapeutics, what can biopharmaceutical labs in late development or QC do to increase confidence in their bioseparations – other than to run more assays?
Multiple attribute monitoring has become a hot topic of discussion within biopharmaceutical organizations as the methodology allows detection and measurement of more critical quality attributes than conventional methods. Waters recently sponsored an outstanding webinar on… Read more >