There’s no question that we’ve entered the age of smart technology. Your phone, your home, your refrigerator, even your light bulbs are all getting smarter. Such technologies do more and more to run themselves, removing steps and complexity, while making user interactions easier and more intuitive. They continually improve, and as they do they become…
In late January, I traveled to WCBP (Well Characterized Biological Products), an industry conference that is hosted every year by the CASSS organization. It serves as a forum that brings together biopharmaceutical industry professionals and various regulatory agencies from around the world to review and discuss the current and future state of biopharmaceutical drug development….
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.
We listened and learned how scientists separate mAbs and ADCs; then we designed a novel column for LC-MS bioseparations A critical step toward the prolific and successful use of monoclonal antibodies (mAb) as biotherapeutics occurred in 1988 when techniques were introduced to humanize these biomolecules, eliminating or reducing the deleterious patient side effects that previous…
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.
“Assuming continuous improvement is a worthy goal, there is every reason to improve validated chromatographic methods if you’re working with the right instrument technology,” says Eric Grumbach of Waters. See what that means for developing and transferring methods for biologic drugs.
A new approach to stationary phase chemistry for reversed-phase LC analysis of proteins, including monoclonal antibodies and antibody drug conjugates, delivers higher fidelity data especially for MS-based peak identification.
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.
The improvements in LC-MS technology under GxP compliant-ready informatics for biopharmaceutical analysis has prepared the industry to expand the role of MS technologies beyond product characterization toward monitoring product and process quality attributes.