We answer a question as a follow-up to Tip #74 on using Empower’s System Suitability option to calculate the ratio of peak to valley height when there’s a valley between the chromatographic peaks; What about calculating valley height when there are two fused peaks?
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?
Halting a chromatographic analysis where the system is not performing correctly or when another error is evident in the separation is a valuable and scientific way to avoid creating unusable data that needs to be subsequently invalidated following a defined analytical lab error/result SOP. But what do you do with that orphan data?
Lots of questions about calculating impurities in Empower Software! Here’s another answer to a reader who inquired: How do you quantitate impurities against the main component? We’re happy to show how…
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.
We answer another reader’s question about using Empower Software: How do you summarize specified and unspecified impurities in a sample and quantitate them against the main component?
We answer a reader’s question about using Empower Software: How do you calculate impurity response when there are two APIs in the sample?
