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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….
Waters recently surveyed 100 method developers from innovator and generic pharmaceutical companies to better understand their existing challenges and views on Method Lifecycle Management (MLCM). We’ll share with you the top questions and findings from our survey results.
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.
At Chiesi Group’s Chippenham laboratory in the UK, Waters’ UPLC systems with mass detection and informatics keep the team at the forefront of inhalation drug delivery products.
Scientists from Waters and Pfizer collaborated to take on the challenge of engineering a novel reversed-phase LC column for high-throughput separations with enhanced resolution, selectivity, and recovery of target mAbs and ADCs.
For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.
In Japan, Professor Masanori Kataoka finds that the ACQUITY QDa Mass Detector is suitable for the synthesis and analysis of oligonucleotides – and sees ways to expand its use.
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…
Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?
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.