Agilent Technologies Introduces Advanced Multi-Attribute Method Solution to Streamline BioPharma Quality Control and Analytical Testing
Agilent Technologies has announced the launch of a new multi-attribute method (MAM) workflow designed to help pharmaceutical and biopharmaceutical quality control laboratories adopt liquid chromatography high-resolution mass spectrometry (LC/HRMS) technologies within routine regulated testing environments. The newly introduced solution is intended to address longstanding operational and technical challenges that have historically limited broader use of advanced mass spectrometry-based analytical methods in quality control settings.
The company stated that the Agilent MAM workflow combines instrumentation, software, consumables, chromatography columns, and analytical standards into an integrated platform intended to simplify implementation of LC/HRMS-based testing for regulated laboratories. The workflow is specifically designed to support pharmaceutical manufacturers monitoring critical quality attributes during late-stage biologics development and commercial production.
The launch reflects growing industry and regulatory interest in MAM technologies as biologic medicines become increasingly sophisticated and manufacturing oversight requirements continue to evolve. Advanced therapeutic modalities such as gene therapies, antibody-drug conjugates, fusion proteins, and other complex biologics are creating greater demand for analytical systems capable of providing detailed molecular characterization with improved efficiency.
Traditional quality control testing for biologics often requires multiple separate analytical assays to evaluate different product attributes, including glycosylation patterns, sequence variants, oxidation, deamidation, aggregation, and other structural or chemical modifications. These fragmented testing approaches can be time-consuming, resource-intensive, and operationally complex.
Multi-attribute methods aim to consolidate many of these measurements into a single LC/HRMS-based workflow capable of simultaneously monitoring multiple product characteristics. By combining several quality assessments into one analytical platform, MAM has the potential to improve testing efficiency while providing deeper molecular insight into biologic products.
Industry adoption of MAM has accelerated in recent years as regulators and pharmaceutical companies increasingly recognize the advantages of more comprehensive and data-rich analytical methods. Guidance from organizations such as the United States Pharmacopeia, particularly USP chapter <1060>, has further reinforced the relevance of LC/HRMS-based MAM approaches for quality control lot release and ongoing manufacturing monitoring.
USP <1060> outlines important considerations for implementing MAM technologies in regulated environments and reflects broader regulatory acceptance of advanced analytical methodologies for biologics characterization and manufacturing control.
Despite this growing interest, many quality control laboratories have faced challenges in integrating LC/HRMS into routine operations. Historically, mass spectrometry systems have often been viewed as too complex, resource-intensive, or specialized for traditional QC workflows, particularly in highly regulated commercial manufacturing environments where consistency, reproducibility, and compliance are essential.
Agilent’s newly introduced workflow is designed to overcome these barriers by streamlining the adoption process and integrating MAM into existing laboratory infrastructures. According to the company, the solution supports laboratories already using OpenLab CDS, enabling smoother transfer of analytical methods from research and development into commercial manufacturing operations.
Method transfer from development laboratories to manufacturing quality control environments has traditionally represented a major challenge in pharmaceutical analytics. Research-focused workflows often rely on highly specialized expertise and flexible procedures that can be difficult to reproduce within tightly controlled commercial manufacturing settings.
By aligning MAM workflows with established QC systems and simplifying data acquisition, analysis, and reporting processes, Agilent aims to reduce operational complexity while supporting more efficient batch release and regulatory compliance.
Simon May, Senior Vice President of Agilent’s Life Sciences and Diagnostics Group, stated that quality control laboratories are increasingly being asked to manage more complex biologic products while simultaneously maintaining high standards for reliability, consistency, and regulatory adherence.
According to May, the newly launched workflow reflects Agilent’s broader strategy of helping customers adopt advanced analytical technologies in ways that fit the practical realities of regulated quality control environments. He emphasized that pharmaceutical manufacturers require solutions capable of delivering sophisticated molecular analysis without disrupting existing workflows or creating excessive training burdens.
The growing complexity of biologic medicines is one of the key factors driving interest in advanced analytical approaches such as MAM. Modern biologics frequently involve highly engineered molecular structures and intricate manufacturing processes that require precise characterization to ensure product quality, safety, and efficacy.
For example, antibody-drug conjugates combine monoclonal antibodies with cytotoxic payloads, creating structurally complex therapies that demand extensive analytical monitoring. Similarly, gene therapies and fusion proteins may exhibit multiple critical quality attributes that need to be carefully tracked throughout development and manufacturing.
Traditional analytical strategies often require separate methods to assess each of these attributes individually, increasing testing time, operational costs, and workflow complexity. MAM technologies offer the potential to consolidate these evaluations into unified assays capable of monitoring multiple product characteristics simultaneously.
Agilent believes its integrated workflow can help laboratories apply these advanced analytical capabilities more routinely and efficiently within regulated settings. By combining instrumentation, chromatography, consumables, standards, and software into a coordinated ecosystem, the company aims to simplify implementation and improve operational consistency.
The solution also reflects broader trends toward digitalization and automation in pharmaceutical manufacturing and laboratory operations. Modern analytical platforms increasingly emphasize integrated software environments, automated workflows, and standardized reporting capabilities to support scalability and compliance in highly regulated industries.
Agilent noted that the workflow is designed to streamline not only analytical measurements themselves but also downstream data processing and reporting. Data management has become an increasingly important challenge in advanced analytical testing because LC/HRMS methods generate large volumes of highly detailed molecular information.
Efficient handling and interpretation of this data are critical for enabling practical routine use in manufacturing environments. Laboratories implementing MAM approaches require systems capable of simplifying data review while maintaining traceability, reproducibility, and compliance with regulatory expectations.
Angelica Riemann, Senior Vice President of the Agilent CrossLab Group, said the continued rise of complex biologic modalities is creating demand for analytical systems that can manage this complexity without disrupting established QC processes.
According to Riemann, integrating MAM into existing laboratory workflows enables customers to apply advanced analytical technologies where they are most needed while supporting confident and routine use within regulated environments. She emphasized that operational practicality remains essential for broader industry adoption of LC/HRMS-based quality control testing.
The release of the MAM workflow comes at a time when pharmaceutical manufacturers are under increasing pressure to improve manufacturing efficiency, accelerate development timelines, and maintain high product quality standards amid growing biologics pipelines.
Regulators have also shown increasing interest in analytical modernization initiatives that support enhanced process understanding and product control. Advanced analytical methods such as MAM may eventually contribute to more adaptive manufacturing strategies, real-time quality monitoring, and streamlined product release processes.
While widespread implementation of LC/HRMS-based MAM workflows in commercial quality control remains an evolving process, industry momentum continues to build as technologies become more standardized and operationally accessible.
Agilent stated that its MAM solution is now available globally for pharmaceutical and biopharmaceutical manufacturers seeking to implement LC/HRMS-based testing methods in regulated quality control environments. The company believes the integrated workflow can help accelerate adoption of advanced analytical technologies while supporting the evolving needs of biologics manufacturing and quality assurance.
As biologic therapeutics continue becoming more structurally sophisticated and personalized, the role of comprehensive analytical platforms is expected to expand significantly. Solutions capable of integrating molecular characterization, automation, compliance, and operational simplicity may play an increasingly important role in the future of pharmaceutical quality control and biologics manufacturing.
About Agilent Technologies
Agilent Technologies, Inc. (NYSE: A) is a global leader in analytical and clinical laboratory technologies, delivering insights and innovation that help our customers bring great science to life. Agilent’s full range of solutions includes instruments, software, services, and expertise that provide trusted answers to our customers’ most challenging questions. The company generated revenue of $6.95 billion in fiscal year 2025 and employs approximately 18,000 people worldwide. Information about Agilent is available at www.agilent.com.
