Novel Intact Multiple Attribute Methodology Workflow

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Webinars by Technology Networks

In recent years, multiple attribute method (MAM) has gained popularity in monitoring biologic product quality attributes (PQAs) of biotherapeutics within late-stage development and manufacturing laboratories. The concept of MAM is to offer a single method capable of monitoring various PQAs simultaneously. However, current MAM solutions require the generation of peptides from a protein digest, which is time consuming and increases the possibility of inducing PTMs during sample manipulation. The implementation of MAM for intact mass analysis (including subunit analysis) has attracted high interest in the biopharmaceutical industry. With SCIEX OS 1.7 software, SCIEX offers an integrated and compliant solution for both intact and peptide level attribute monitoring. Two liability studies, oxidation stress (LC separation) and high pH stress (CE separation), were employed to demonstrate the application of SCIEX flexible solution for MAM.