Over the past few years, the mass spectrometry-based Multi-Attribute Method (MAM) has gained traction due to its potential to streamline lab work and decrease development time. However, several barriers to adoption remain, one of which is evaluating performance of MAM vs. conventional methods.  

To evaluate the performance of MAM vs conventional methods, adalimumab and etanercept were procured from multiple sources, and subjected to forced degradation to generate a range of modifications. Samples were analyzed using both conventional and MAM approaches to evaluate size variants, charge variants, glycosylation, sialic acid content, and other molecular variants like oxidation, deamidation, and glycation.

The ability of each technique to detect differences between nominally similar products and forced degradation-induced changes was evaluated. Physiochemical differences were compared to functional and structural changes detected using cell-based assays, binding assays, and circular dichroism. The knowledge base from this study can help lower the barrier to adoption of MAM, enabling greater efficiency and reducing costs.  

Presented by Diane McCarthy, Senior Director, Science and Standards, Global Biologics Department at US Pharmacopeia.

Dr. McCarthy is Senior Director, Science and Standards in the Global Biologics Department at the US Pharmacopeia. She leads development and maintenance of standards and tools to support quality of medicines and oversees the USP biologics laboratories in the US and India. Her team supports a diverse range of biological therapies, including monoclonal antibodies and other protein therapeutics, vaccines, peptides, and cell and gene therapy. Prior to joining USP, Diane worked for several small CROs that focused on the use of mass spectrometry for characterization of biologics, host cell proteins, and biomarkers. Dr. McCarthy earned her Ph.D. in Biochemistry from the University of Texas at Austin.

Precision in Practice: MAM’s Role in Biotherapeutic Attribute Understanding at Pfizer

The rapid advancement of biotherapeutics, including monoclonal and multi-specific antibodies, Fc-fusion proteins, gene therapies (AAV vectors), mRNA vaccines, recombinant proteins, and antibody-drug conjugates (ADCs), requires analytical platforms that offer both depth and flexibility. This webinar highlights how Pfizer utilizes heightened characterization by liquid chromatography mass spectrometry (LC-MS) and the Multi-Attribute Method (MAM) to drive process and product development across these diverse modalities.

Attendees will discover how LC-MS enables comprehensive structural and functional characterization, delivering detailed insights into critical product quality attributes (PQAs) at every stage of development. The session will showcase MAM’s transformative role as a high-throughput platform for simultaneous monitoring of multiple PQAs, supporting process optimization and comparability assessments.

Real-world case studies will demonstrate how LC-MS and MAM inform process optimization and understanding, analytical comparability assessments, manufacturing investigations, regulatory submissions, and ensure consistent product quality from early research through commercial launch. By incorporating LC-MS and MAM into its analytical packages, Pfizer enhances decision-making, streamlines development, and upholds the highest standards of safety and efficacy for patients. This webinar is ideal for scientists, engineers, and regulatory professionals interested in the future of analytical science in biotherapeutics.

Presented by Andrew W. Dawdy, Ph.D. Senior Principal Scientist at Pfizer

Andrew William Dawdy, Ph.D., is a Senior Principal Scientist at Pfizer, St. Louis, MO with 16 years of mass spectrometry experience and 12 years in the pharmaceutical industry. He specializes in LC-MS characterization to support biotherapeutic process and product development, leading strategies for over 15 biotherapeutic submissions, including mAbs, ADCs, multi-specifics, and mRNA vaccines. Andrew has authored 35+ scientific publications and presentations, co-developed Pfizer’s Multi-Attribute Method (MAM) platform, and co-authored USP <1060> on MAM with a cross-industry LC-MS team. He continues to drive innovation in analytical characterization, regulatory authoring, project leadership, and cross-functional collaboration.

Towards MAM in QC: Accelerating Adoption with Streamlined Data Analysis Strategies

The multi-attribute method (MAM) offers significant potential to replace certain conventional release and stability assays, yet widespread adoption has been slowed by challenges such as reliable new peak detection (NPD) while minimizing false positives. These hurdles, combined with the need to monitor critical quality attributes (CQAs) and support tradition in-depth characterization activities, often force analysts to rely on multiple software solutions to meet their goals.

In this presentation, we introduce a comprehensive, GxP-ready MAM workflow designed for both CQA monitoring and robust NPD. The workflow integrates advanced features to reduce false positives, including statistical scoring, artifact filtering, and curated known-peak libraries. Users have successfully validated this approach in accordance with ICH Q2 guidelines and applied it across development and MAM applications, achieving sensitive and accurate identification of new peaks with zero false positives. This streamlined solution enables efficient implementation of MAM while maintaining compliance and analytical rigor.

Presented by Michelle English, Ph.D., Scientific Consultant at Genedata

Dr. Michelle English is a Scientific Consultant at Genedata, where she supports global clients in solving complex mass spectrometry challenges. After an early career in programming and systems analysis, she returned to academia to earn a chemistry degree, followed by postgraduate research in Don Hunt’s lab at the University of Virginia. Michelle’s work on advanced mass spectrometry techniques led her to remain as research faculty after graduation. In 2014, Michelle joined Pfizer, contributing to the mass spectrometry characterization group focused on developing innovative analytical methods to support drug development from early to late stages. Prior to joining Genedata in 2024, she worked at mass spectrometry and software vendors, applying her expertise across a wide range of protein therapeutic applications. At Genedata, her recent focus has been on Multi-Attribute Method (MAM) workflows, where she helps clients implement novel new peak detection (NPD) strategies using Genedata Expressionist. Michelle’s unique blend of scientific depth and software experience enables her to bridge technical and practical needs, delivering impactful solutions that improve efficiency and insight in biopharmaceutical analysis.

Attribute-Centric Biotherapeutic Characterization by Peptide MAM on Waters LC–MS Platforms

Multi-attribute Method (MAM) workflows on Waters LC–MS platforms enable simultaneous characterization and routine monitoring of critical quality attributes for monoclonal antibodies and other biotherapeutics in a single peptide-level assay. Integrated ACQUITY Premier UPLC  with BioAccord and Xevo G3 QTof mass detection delivers high-confidence peptide mapping, targeted quantification of product and process variants, and new peak detection to support purity and stability assessments. The compliance-ready waters_connect informatics environment unifies peptide mapping, scientific library creation, and Peptide MAM Apps to streamline method deployment from characterization through manufacturing and QC. This talk will highlight practical implementation of peptide MAM using Waters analytical tools, emphasizing end-to-end workflow robustness, data integrity, and the ability to transfer attribute-based methods across instruments and sites for innovator and biosimilar development.

Presented by Ying Qing Yu, PhD, Director of the Biopharmaceutical Applications Team at Waters Corporation

Ying Qing Yu, PhD, is Director of the Biopharmaceutical Applications Team at Waters Corporation in Milford, Massachusetts, where she has led analytical method development since joining in 2001 shortly after earning her PhD in Analytical Chemistry from Purdue University.

Ying Qing has led a variety of projects focused on biotherapeutics analysis using technologies such as ultra-high-performance liquid chromatography (UPLC), and high-resolution mass spectrometry. Her work spans Glycan profiling, Peptide mapping, Multi-Attribute Method, Bioseparation, Oligonucleotide impurity analysis, and adeno-associated virus (AAV) characterizations. Dr. Yu’s leadership has resulted in the development of innovative and fit-for-purpose analytical solutions that support both internal product development and external customer needs in the biopharmaceutical sector. A dedicated mentor and collaborator, Dr. Yu manages a team of scientists and fosters a culture of curiosity and excellence, inspiring innovation and impactful problem-solving. 

Followed by a live Question and Answer session

Sponsored by Genedata and Waters Corporation

About Genedata
Genedata transforms data into intelligence with innovative software solutions that incorporate extensive biopharma R&D domain knowledge. Multinational biopharmaceutical organizations and cutting-edge biotechs around the globe rely on Genedata to digitalize and automate data-rich and complex R&D processes. From early discovery all the way to the clinic, Genedata solutions help maximize the ROI in R&D expenditure. Founded in 1997, Genedata is headquartered in Basel, Switzerland with additional offices in Boston, London, Munich, San Francisco, Singapore, and Tokyo.

About Waters Corporation
Waters Corporation, headquartered in Milford, Massachusetts, is a leading provider of analytical instruments, software, and services for scientists worldwide. Founded in 1958, the company specializes in high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and mass spectrometry (MS) systems. 

Waters Corporation’s tools are essential for chemists, enabling precise and accurate analysis of complex mixtures. Their liquid chromatography systems are widely used for separating, identifying, and quantifying components in chemical samples. These systems are crucial in various fields, including pharmaceuticals, environmental testing, food safety, and clinical diagnostics. 

In addition to chromatography, Waters offers mass spectrometry solutions that provide detailed molecular information, aiding chemists in understanding the composition and structure of substances. Their integrated software solutions enhance data analysis, ensuring that chemists can efficiently interpret results and maintain compliance with regulatory standards 

Waters Corporation’s commitment to innovation and quality has made them a trusted partner for laboratories around the globe. Their comprehensive range of products and services supports chemists in achieving reliable and reproducible results, driving advancements in scientific research and development.