Strengthen GLP-1 Peptide CMC Strategies Through Analytical Development

GLP-1 peptide therapeutics are rapidly reshaping the treatment landscape for diabetes and obesity, creating increased demand for robust formulation development and comprehensive analytical characterization strategies that enable safe, scalable and market-ready drug products. This webinar explores integrated approaches to GLP-1 peptide development, highlighting how formulation science and analytical strategy work together to accelerate CMC readiness and regulatory success.

As global programs advance from early development to commercialization, GLP-1 drug products present unique challenges related to peptide stability, solubility, aggregation behavior, viscosity control, device compatibility and manufacturability. Addressing these complexities requires deliberate formulation design supported by scientifically rigorous analytical control strategies.

This webinar will examine contemporary formulation approaches, including rational excipient selection, fatty acid conjugation, incorporation of non-canonical amino acids and strategies to optimize solubility and viscosity for injectable delivery systems. Case references from marketed therapies such as liraglutide, semaglutide and tirzepatide will provide real-world development context.

A significant portion of the webinar will focus on advanced analytical characterization tools that underpin GLP-1 peptide quality and lifecycle management. Techniques, including LC–MS, SEC–MALS, surface plasmon resonance (SPR), peptide mapping, cell-based bioassays and stability-indicating methods, will be discussed from both scientific and regulatory perspectives. The session will demonstrate how integrated analytical data informs Critical Quality Attributes (CQAs), supports control strategy development and strengthens CMC documentation for global regulatory submissions.

Participants will gain practical insights into aligning formulation decisions with analytical evidence to enhance product consistency, scalability and compliance across development phases.

Register for this webinar to learn how integrated formulation and analytical development strategies can support robust GLP-1 peptide development and advance programs efficiently toward market readiness.

Speakers

Nandakumar Sundaramoorthy, PhD (Dr. rer. medic.), Director & Head – Analytical Development Department, OneSource Specialty Pharma

With over 19 years of experience in the biopharmaceutical industry, Nanda serves as Director of Analytical Sciences, leading end-to-end analytical strategy across biologics, peptide therapeutics, complex injectables, oral soft-gel capsules and drug–device combination products.

He brings deep expertise in complex product characterization, analytical control strategy development and regulatory-aligned method design across development phases. His experience spans early research through late-stage development, supporting CMC readiness and global regulatory submissions including EMA, USFDA and ANVISA.

Nanda has contributed to vaccine and antigen candidate programs through collaborations with leading research institutions, including the University of Maryland School of Medicine, Ghent University and Universität Münster.

He leads cross-functional analytical programs, enabling technology transfers, platform implementation and scientifically robust approaches to purity, potency, structural integrity and lifecycle management, ensuring quality and compliance remain central to development success.

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M.S. Vijaykanth PhD, SVP & Head – R&D, OneSource Specialty Pharma

Vijaykanth is the SVP and Head of Research & Development at OneSource, bringing over 21 years of extensive experience in sterile pharmaceutical research and development. His expertise encompasses complex injectables, novel drug delivery systems and specialty generics for regulated markets worldwide.

He leads the organization’s R&D development strategy, driving innovation in sterile product development, process optimization and regulatory-aligned formulation design. Vijaykanth has played a pivotal role in establishing robust development frameworks and building scalable R&D capabilities that enable the successful execution of niche and technically challenging sterile programs.

Prior to joining OneSource, he held senior leadership positions at leading pharmaceutical organizations, including Intas Pharmaceuticals, Astron Research and Mylan, where he served as Director – R&D. Over the course of his career, he has successfully led cross-functional teams and advanced multiple complex development programs across global markets.

Vijaykanth holds a PhD in Pharmaceutical Sciences from DAVV, Indore, and a Master’s degree from Dr. H.S. Gour University, Sagar. He has authored numerous scientific publications and holds several patents in the field of pharmaceutical development.

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