Agilent Launches Multi-Attribute Method (MAM) Solution for BioPharma Quality Control

Key Terms

liquid chromatography technical

Liquid chromatography is a laboratory technique that separates, identifies and measures chemicals in a liquid sample by passing it through a material that slows different compounds by different amounts, like a filter that sorts marbles by size and weight. Investors care because it underpins drug development, quality control and diagnostics: reliable separation and measurement affect product safety, regulatory approval, manufacturing consistency and marketability.

united states pharmacopeia regulatory

United States Pharmacopeia is an independent nonprofit that creates and enforces quality standards for medicines, dietary supplements and ingredients used in health products, acting like an instruction manual or quality checklist that manufacturers and regulators follow. Investors care because meeting or failing these standards affects whether products can be legally sold, influences manufacturing costs, risk of recalls or regulatory action, and therefore can change a company's revenue, reputation and liabilities.

gene therapies medical

Gene therapies are medical treatments that change or replace a person’s genetic instructions to fix or counteract a disease, using biological delivery methods to get the new material into cells — like repairing or swapping pages in a faulty instruction manual. They matter to investors because they can offer one-time or long-lasting cures with large market potential, but carry high development costs, regulatory scrutiny and manufacturing challenges that make outcomes binary and investment risky.

antibody-drug conjugates medical

A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.

SANTA CLARA, Calif.--(BUSINESS WIRE)-- Agilent Technologies Inc. (NYSE: A) today announced the release of a new multi-attribute method (MAM) workflow designed to help pharmaceutical and biopharmaceutical quality control (QC) laboratories implement liquid chromatography high-resolution mass spectrometry (LC/HRMS) in routine, regulated testing environments.

The Agilent MAM solution brings together software, instrumentation, columns, consumables and standards to address practical and operational barriers that have historically limited the use of LC/HRMS in QC environments. The workflow is designed to support laboratories applying MAM to monitor critical quality attributes during late-stage development and commercial manufacturing.

Regulatory and industry interest in MAM has increased as biologics grow more complex, and expectations for analytical control continue to evolve. Guidance such as United States Pharmacopeia (USP) chapter <1060> highlights considerations for implementing MAM using LC/HRMS, reinforcing its relevance for QC lot release and ongoing manufacturing control.

“Quality control laboratories are under increasing pressure to manage more complex biologic products while maintaining consistency, reliability, and compliance,” said Simon May, senior vice president of Agilent’s Life Sciences and Diagnostics Group. “This workflow reflects Agilent’s focus on helping customers adopt advanced analytical approaches in a way that fits the realities of regulated QC environments.”

The solution is designed to integrate into existing QC labs using OpenLab CDS, supporting method transfer from research and development into manufacturing. By streamlining data acquisition, analysis, and reporting, the workflow aims to reduce complexity and training requirements while supporting efficient batch release.

In addition to regulatory drivers, the growing adoption of advanced modalities, including gene therapies, fusion proteins, and antibody-drug conjugates, is increasing demand for analytical techniques capable of monitoring multiple critical quality attributes in a single method. MAM enables consolidation of measurements that have traditionally required multiple, separate tests.

“As biologic modalities become more complex, laboratories need analytical solutions that help them manage that complexity without disrupting established QC processes,” said Angelica Riemann, senior vice president of the Agilent CrossLab Group. “By integrating MAM into existing QC workflows, Agilent is helping customers apply advanced analytical approaches where they are needed most, supporting confident, routine use in regulated environments.”

The Agilent MAM solution is available globally and supports pharmaceutical and biopharmaceutical manufacturers seeking to adopt LC/HRMS-based methods in regulated QC environments.

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. To receive the latest Agilent news, subscribe to the Agilent Newsroom. Follow Agilent on LinkedIn and Facebook.

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Media Contact
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Agilent Technologies Inc.
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Source: Agilent Technologies Inc.