SCIEX, a global leader in life science analytical technologies, today announced the newly released BioPharmaView™ Software 3.0 solution for the complete LC-MS Multiple Attribute Methodology (MAM) Workflow, that enables simple yet in-depth characterization of biologics through powerful mass spectrometry. Moving to LC-MS-based MAM workflows has historically been challenging for biopharma labs and CROs due to unnecessary complexity in data processing and analysis caused by the lack of a single software platform. The SCIEX Workflow for MAM addresses this need, offering a unique, single software solution for routine running of a high-resolution LC-MS assay during biologics development.
The growing popularity of protein-based drugs as treatments for various illnesses has resulted in the need for new analytical methods that are faster and more cost-effective. The complex nature of biologics means that high-resolution, sensitive instruments are needed to identify differences between protein structures. The MAM Workflow has been specifically designed for use by biopharma researchers, with emphasis placed on making the technology easy to implement, learn and use. Biologics can now be characterized within shorter timescales and to a higher level of detail, including product quality attribute (PQA) monitoring, quantitation, and impurity monitoring. The burden of analyzing these data and reporting final results has also been simplified by integrating all necessary steps in the BioPharmaView software.
The SCIEX Workflow for MAM combines the high performance of a state-of-the-art mass spectrometer with the newly upgraded processing software. Currently, two SCIEX mass spectrometers are designed to integrate well with the MAM Workflow. Firstly, the SCIEX X500B QTOF System provides robust and simple therapeutic analyses in a single, compact and easy-to-use platform.
Alternatively, the high-performance SCIEX TripleTOF® 6600 System can be integrated into the workflow. This powerful system’s flexibility makes it capable of performing comprehensive characterization and quantitation while also allowing for MAM method development suitable for a biopharma laboratory.
"BioPharmaView Software 3.0 comes complete with new features for performing a complete MAM workflow in a single software suite, along with the ability to automate core biologics characterization workflows, such as intact mass, subunit mass, and peptide mapping analyses. The BioPharmaView Software 3.0 has been built based on customer feedback, simplifying and automating the intensive data processing steps to make biotherapeutic characterization data processing faster, easier and more productive in a simplified view.
"Developing a powerful MAM Workflow for biotherapeutic product monitoring can provide orthogonal data to other conventional analytical assays, while providing deeper information on the biologic,"" said Susan Darling, Senior Director, BioPharma Business at SCIEX. "In the future this may drive a reduction in the number of tests needed during biologic research, which may therefore have the effect of reducing development costs and accelerate the timeline and ensuring product quality."
The development of the SCIEX solution for MAM workflow demonstrates SCIEX's continual commitment to the success of the biopharma field. By requiring fewer characterization methods to be performed in tandem, and instead performing them in one LC-MS run, SCIEX provides solutions to companies looking for alternative cost-savings.
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