Biopharmaceutical laboratories working across R&D, manufacturing, and quality control (QC) environments can now streamline biopharmaceutical characterization, process monitoring, and release testing using a new seamless, built-for-purpose multi-attribute method (MAM) workflow.
The Thermo Scientific MAM 2.0 workflow is a culmination of collaborations and conversations with industry leaders that led to features added specifically to address MAM user needs. The result is an end-to-end, single-vendor solution providing a holistic ecosystem for implementation from biotherapeutic development through to QC. The MAM 2.0 solution enables direct connectivity in both hardware and software through all stages of development and manufacturing.
The workflow manages all analytical processes from instrument control to data management through a secure, integrated software ecosystem, streamlining the process from development to QC. The Thermo Scientific BioPharma Finder 5.0 software provides MAM users with fit-for-purpose enhancements for confident attribute characterization, data security and integrity, customizable reporting, and team collaboration at a global scale. From instrument control to data storage and processing, through to result generation, Thermo Scientific Chromeleon Chromatography Data System 7.3.1 software manages the analytical processes and enables a simple transfer of the entire MAM workflow from development to QC.
Laboratories will benefit from a consistent technology platform between the Thermo Scientific Orbitrap Exploris 240 mass spectrometer in development and the new Thermo Scientific Orbitrap Exploris MX mass detector, specifically designed for QC applications. Both solutions together will future proof customer needs and enable consistent unit-to-unit performance, while continuing to offer the power of Orbitrap technology. Furthermore, MAM 2.0 includes training, ongoing support, and relationships with laboratories to bring their next biotherapeutic candidate straight through to breakthrough.
Thermo Fisher Scientific is showcasing its new workflow during the 69th American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics, being held October 31-November 4, in the Pennsylvania Convention Center, Philadelphia, Pennsylvania.
"We see time and time again that customers face bottlenecks when moving therapeutics from development to manufacturing, ultimately disrupting and delaying commercialization and the delivery of drugs to patients," said Eric Grumbach, director, pharma and biopharma, chromatography and mass spectrometry, Thermo Fisher Scientific. "The MAM 2.0 workflow enables the use of the same platform throughout the entire process, delivering substantial time saving benefits and allowing product and process knowledge sharing across departments and teams."
Sara Carillo, biopharmaceutical application development team leader, National Institute of Bioprocessing Research and Training (NIBRT) said, "As we continue to utilize mass spectrometry methods within QC environments, supporting the accurate and reliable analysis of therapeutics, there is a need for connected, compliance-ready solutions that can help streamline the transfer of methods from development to QC laboratories. The MAM 2.0 workflow provides us with seamless knowledge transfer, and a built-for-purpose mass spectrometer for QC testing, enabling us to develop and release safe and effective biologics more efficiently."