The multi-attribute method, known as MAM, employs a liquid chromatography-mass spectrometry (LC-MS) technique. It serves as a peptide mapping application, enabling the direct analysis and monitoring of a wide array of product quality attributes (PQAs) at the amino acid level in biopharmaceutical products. This method is applicable throughout the product's journey from process development to quality control release.
Even minor alterations in the protein sequence can significantly impact the safety and biological effectiveness of biotherapeutics. Through direct measurement of potential PQAs, valuable insights are gained to refine production processes, ultimately enhancing the overall product quality.
The meticulous evaluation and continuous tracking of potential PQAs play a pivotal role in ensuring the product's quality, safety, and efficacy. Traditional methods for assessing potential PQAs involve resource-intensive approaches like multiple chromatographic and electrophoretic techniques. However, these methods are profile-based and often fall short in identifying and quantifying potential PQAs linked to specific residues. Incorporating the MAM approach can revolutionize the understanding and optimization of biopharmaceutical production, offering a comprehensive and efficient means to maintain product excellence.
Historically, the implementation of MAM has not been easy or fast due to the absence of a complete commercial MAM solution. Scientists have had to piece together multiple hardware and software components originally designed for different purposes. Such MAM solutions often require expert MS users and are not without challenges when deployed in process development and QC environments.
Being the leading biotherapeutic solution provider and a trusted partner, Thermo Fisher Scientific has been working closely with industry leaders to develop a seamless, fit-for-purpose MAM solution.
Presented by Andrew W. Dawdy, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences Pfizer, Inc.
Build your process knowledge within a compliance-ready, enterprise MAM data system that connects instruments, functions, departments and sites throughout development and manufacturing, enabling seamless data and knowledge sharing.
Simplify your routine operations without compromising data quality on Thermo Scientific Orbitrap Exploris MX mass detector, built on the same platform as Thermo Scientific Orbitrap Exploris 240 mass spectrometer. Eliminate lengthy method development in QC with direct method transfer within compliance-ready Chromeleon CDS software.
|Separation||Mass Spectrometry||Enterprise Data Management||System Performance Evaluation Tests (SETs)|
Recommended configuration – Attribute Characterization
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Recommended configuration – Routine Monitoring
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Future proof your biotherapeutic development and QC with industry proven Orbitrap technology, now purposely designed for MAM.
Ensures high confident product quality attributes (PQAs) characterization and quantification with high quality spectra.
Designed for QC environment with consistent and reliable unit-to-unit performance and extended life cycle, while delivering the same high quality HRAM data:
Build your process knowledge within a compliance-ready enterprise data system that connects instruments, functions, departments, and sites throughout development and manufacturing, enabling seamless data and knowledge sharing at global scale.
From instrument control and data acquisition to automated data processing to customizable reports to easy electronic data reviews Chromeleon CDS facilitates compliant-ready CQA monitoring and new peak detection while ensuring data integrity requirements are met. User defined roles and permissions with the benefits of a scalable enterprise system provide the environment for global collaboration to ensure seamless method transfer and execution from development to QC.
Provides confident identification and quantitation of PQAs with easy-to-understand data visualization and customizable reporting tools, introduces the collaboration of data processing and reporting at global scale, ensures data integrity and security in a multi-user collaborative environment, and facilitates defining processing criteria in targeted monitoring.
The Thermo Scientific Ardia platform is designed for scientists running chromatography and mass spectrometry analyses and enables them to combine, aggregate, compare, interrogate and share information via a common digital language. It allows for the highest uptime, security, and global compliance standards in the sharing of previously siloed data.
Designed for each system configuration. Supports thorough assessment of the performance of the entire system, based on an SOP containing a defined list of acceptance criteria, at installation and subsequent maintenance appointments, ensuring consistent high-quality results, utilizing Pierce BSA Protein Digest Standard and Fisher Scientific LC-MS grade solvents are used for SETs.
Combination of on-site and remote trainings are conducted by MAM application experts, customizable to meet your needs.
Installation, training, service, and support are managed by a dedicated global support team of Thermo Scientific MAM experts, providing fast response to maximize system uptime and your productivity.
Hear Rich Rogers discuss his vision of what the future may hold for the multi-attribute method (MAM) in the biopharmaceutical industry.