MAM is an emerging mass spectrometry application in the quality control (QC) of biotherapeutics. No matter where you are in your MAM development process, we have a pathway for you.
In general, there are two main routes to establish a QC-ready MAM: Historically, chromatography-based methods were preferred in the QC settings, and are still widely used in the industry. More recently, MS feature-based methods have gained popularity. The good news is that both options are available in Protein Metrics Byos® and Byosphere® software, including compliance ready options for GMP environment.
Despite the standardized acronym, there is a wide variety of instrumentation and data acquisition techniques actively used for MAM in the industry. Some of these were highlighted in the new peak detection interlaboratory study by Mouchahoiret al.(J. Am. Soc. Mass Spectrom. 2021, 32, 913−928).
The single Byos MAM workflow performs all necessary tasks: identification of peptides and their variants using MS1 and MS2, label-free quantification of peptides, and MS1 feature comparison across samples, all in a single workflow. The software is flexible: with a few clicks, it can be adjusted to match any organizational process. MS2-based methods are as easily processed as MS1-based or mixed MS1 and MS2 protocols. MS2 can be acquired via data-dependent acquisition (DDA) or data-independent acquisition (DIA). New peak detection may be MS1-feature based, or it may be chromatogram based (TIC or UV). The software does not define the process; rather, it is configurable to match organizational needs.
Two revamped MAM applications notes are available on our website, which describe how to identify, validate, and quantify CQAs as well as detect new peaks. Check them out below:
Multi-Attribute Monitoring in Byos® Part A – CQA Identification
Multi-Attribute Monitoring in Byos® Part B – New Peak Detection & CQA Quantification