Peptide Impurities and GLP-1
Controlling peptide-related impurities is essential to meet regulatory requirements and ensure product quality. The presence of impurities in drug substances and finished products can pose significant immunogenicity risks to patients, potentially leading to drug recalls or warning letters from regulatory bodies.
In this webinar, Dr Manoj Metta from the United States Pharmacopeia (USP) will discuss challenges, regulatory expectations and USP solutions to help ensure the quality of peptide therapeutics. Dr Caitlin Hanna from Waters will describe a reverse-phase LC-UV method development case studies for the impurity analysis of fatty-acid modified GLP-1 receptor agonists.
Key learning objectives:
- Understand the key analytical challenges and regulatory expectations for peptide quality assessment
- Learn about USP products and solutions for peptide impurity analysis
- Explore column screening and method development considerations for the analysis of fatty-acid modified GLP-1 receptor agonists
Presenter: Manoj Kumar Metta, Ph.D. (Principal Scientist, Global Biologics, United States Pharmacopeia (USP))
Dr. Manoj Metta is a seasoned Biological Scientist with 21 years of expertise in biologics quality establishment and regulatory sciences. Currently, he serves as Principal Scientist in Global Biologics at the U.S. Pharmacopeia (USP), where he specializes in the quality assessment of Monoclonals, Peptides, and Oligonucleotide drug products. Over his 14+ years at US Pharmacopeia, Dr. Manoj has made significant contributions to compendial sciences, including the development of monographs, reference standards, and general chapters for biologics.
He also leads research initiatives focused on developing innovative analytical methods, in vitro characterization techniques, and drug release testing methodologies. He is a USP-approved instructor for Biologics education courses and an international speaker, having delivered talks globally. Additionally, he serves as a quality auditor for Quality Management System (QMS) evaluations in supplier qualification.
Dr. Manoj received his Ph.D. in Biotechnology from the Gandhi Institute of Technology and Management.
Presenter: Caitlin Hanna, Ph.D. (Senior Scientist, Waters Corporation)
Caitlin Hanna is an analytical chemist experienced in sample preparation and LC-UV/MS for biopharmaceutical CQA analysis. She received her PhD in Chemistry from the University of California, Irvine in 2019 and joined Waters Corporation in 2022. Currently, she serves as Senior Scientist in the Bioseparations portfolio. Her work focuses on the development and application of sample prep and chromatography tools for assessing the quality of mAb and peptide biotherapeutics.
Moderator: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)
Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.
