27th February 2025 | 10:00am EST / 7:00am PST / 3:00pm GMT / 4:00pm CET | Sarita Kattel, M.S, Principal Scientist, Global Biologics at USP, Khaled Yamout, CEO at Yamout Chem Consulting, LLC, Martin Gilar, Ph.D., Scientific Fellow, Seperations R&D group at Water Corporation, Roxanna Eggleston-Rangel, Applications Scientist at Phenomenex |BOOK FREE SEAT FOR THIS WEBINAR
The approval and widespread adoption of mRNA vaccines have revolutionized the field of immunization, offering rapid and scalable solutions to combat infectious diseases. This success has spurred significant research into using mRNA for other therapies, including cell therapies, protein production, genome editing and protein replacement. Ensuring the quality and safety of mRNAs in these therapies is crucial, requiring detailed impurity profiling and advanced analytical techniques. Incorporating mRNA into drug products presents significant manufacturing and analytical challenges, particularly in maintaining the integrity of mRNA drug substances and drug products. Rigorous release and stability testing are essential to ensuring these therapeutic products remain effective and safe throughout their lifecycle.
Impurity profiling is an essential part of analytical characterization for mRNA-based products. During production, both process and product impurities can arise, such as truncated mRNA fragments, double-stranded RNA (dsRNA), and residual DNA from the plasmid template. These impurities can potentially impact the drug’s performance or trigger unintended immune responses. This presentation explores the types of impurities commonly found in mRNA-based products and the advanced analytical methods used to analyze them. We will also discuss the challenges faced, potential solutions, and the importance of analytical methods in supporting development programs and meeting expanding regulatory requirements. Continuous improvements in these analytical methods are crucial to address the evolving challenges in mRNA-based drug production and to maintain high standards of safety and effectiveness.
This presentation will:
- Discuss challenges analyzing mRNA-based products due to the complexity of the mRNA molecules and the stringent quality requirements
- Delve into the analytical techniques used to profile impurities in mRNA products
- Propose key analytical techniques and strategies for assessing mRNA quality
Sarita Kattel, M.S, Principal Scientist, Global Biologics at US Pharmacopeia

Sarita Kattel serves as a Principal Scientist in USP’s Global Biologics Department. At USP, she utilizes her extensive vaccine experience to advance the development of standards supporting vaccine manufacturing. Her role also includes creating new standards for analytical testing of oligonucleotide products and exploring additional opportunities for standards in various other areas.
Ms. Kattel’s career spans over biotech companies, academic institutions, contract research organizations (CROs), and pharmaceutical giants like GlaxoSmithKline (GSK) and Janssen Pharmaceuticals. She has held lab-based roles in method development and validation, Chemistry, Manufacturing, and Controls (CMC) leads, as well as quality control, working on monoclonal antibodies, proteins, and mRNA-based vaccines.
Khaled Yamout, CEO at Yamout Chem Consulting, LLC

Khaled Yamout is a thought leader in Analytical Sciences, Quality and Manufacturing. Previously held a position as a Senior Director, Analytical Services and Quality Control at TriLink Biotechnologies where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability to support regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in Quality Control, Research and Development, and Manufacturing where he supported several Drug substances and Drug products (both small molecules and biologics) from clinical phase to commercial. These include diverse experience and expertise ranging from discovery to manufacturing with Fortune 500 firms, as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification covering both manufacturing and analytical testing and characterization.
RNA analysis with liquid chromatography and mass spectrometry.
Martin Gilar, Ph.D., Scientific Fellow, Seperations R&D group at Waters Corporation

Dr. Martin Gilar received his Ph.D. in analytical chemistry from Institute of Chemical Technology in Prague (1996). He spent postdoc years in Hybridon Inc. (1996-1998) and Northeastern University in Boston (1998) developing separation methods for antisense oligonucleotides and fraction collector for DNA molecules. Since 1998 he has worked at Waters Corp. in Milford, Massachusetts, participating in column, sample preparation and instrument research.
Dr. Martin Gilar is a Scientific Fellow in the Separations R&D group at Waters Corporation. He has more than 30 years of experience in the separation sciences, including chromatography, electrophoresis, and mass spectrometry. His research interest is the analysis of biopolymers, peptides, and nucleic acids. He has published over 75 peer reviewed papers. Dr. Gilar is recipient of Jaroslav Janak 2022 medal and Chromatographic Society Jubilee medal in 2023.
Guide RNA and mRNA characterization by chromatography and mass spectrometry
Roxanna Eggleston-Rangel, Applications Scientist at Phenomenex

Roxana Eggleston-Rangel joined Phenomenex in 2018 as an Applications Scientist and is currently working with the applications team to produce analytical solutions for scientists in the biopharma industry. Roxana’s current work focuses on characterization of mRNA, sgRNA and siRNA. Prior to Phenomenex, Roxana worked for Caltech and the University of Southern California developing LC-MS workflows for the proteomics community. Roxana received her bachelor’s and master’s degree in Chemistry and Biochemistry from California State University, Los Angeles.
Sponsored by Waters Corporation and Phenomenex

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.
About Phenomenex
Phenomenex is a global leader in chromatography and purification solutions, providing cutting-edge technologies that drive advancements in the biopharmaceutical industry. With a deep commitment to innovation, Phenomenex offers a comprehensive portfolio of high-performance columns, media, and consumables tailored to address the unique challenges of biopharma research, development, and manufacturing.
From monoclonal antibodies (mAbs) and oligonucleotides to viral vectors and mRNA therapeutics, Phenomenex supports the entire biopharmaceutical workflow. Their solutions enable precise characterization, robust quality control, and efficient purification of complex biomolecules, ensuring compliance with stringent regulatory requirements. With a focus on eliminating bottlenecks in analysis and production, products like the Biozen™ column family and Clarity purification technologies are designed to optimize sensitivity, recovery, and reproducibility, even with the most demanding samples.
Beyond products, Phenomenex empowers customers through expert technical support, application insights, and innovative partnerships, helping accelerate the delivery of life-changing therapies to patients. Their dedication to sustainability and alignment with industry standards further strengthens their position as a trusted partner in biopharma.
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