In this free webinar, understand the mechanisms and types of peptide aggregation during manufacturing. Attendees will learn how to detect and characterize aggregates using orthogonal analytical tools (SEC, DLS, FTIR, TEM and more). The featured speakers will discuss case studies demonstrating practical strategies to overcome aggregation. Attendees will gain insight into regulatory expectations for aggregation control in peptide therapeutics.
TORONTO, June 5, 2025 /PRNewswire-PRWeb/ -- Peptide therapeutics have become an essential modality in treating chronic and complex diseases, including cancer, diabetes and neurodegenerative disorders. However, peptide manufacturing presents persistent challenges, particularly peptide aggregation, which can significantly reduce product yield, bioactivity and safety.
This webinar will provide an in-depth examination of peptide aggregation during drug substance and drug product development, highlighting root causes, detection tools and effective mitigation strategies grounded in real-world case studies.
The featured speakers will begin with an overview of peptide aggregation mechanisms. They will discuss how intrinsic factors such as amino acid sequence and hydrophobicity, along with extrinsic parameters like pH, temperature, stirring and buffer composition, contribute to aggregate formation. Aggregation often occurs during downstream processes, forming amorphous clumps, fibrils or crystalline structures that compromise therapeutic integrity and can trigger immunogenic responses.
To address this, the webinar will introduce a suite of analytical techniques used to detect and characterize peptide aggregates. These analytical methods range from classical tools like size exclusion chromatography with multi-angle light scattering (SEC-MALS) and dynamic light scattering (DLS) to advanced methods such as Thioflavin T assays, Fourier transform infrared (FTIR) spectroscopy, atomic force microscopy (AFM) and nanoparticle tracking analysis. Attendees will gain insight into the relative advantages and limitations of each method, with emphasis on selecting orthogonal strategies that align with regulatory expectations from agencies including the EMA, FDA and ICH.
Practical examples from the manufacturing floor will illustrate how data-driven process development can help mitigate aggregation. Case studies will include high-risk peptides prone to β-sheet-rich fibrillar aggregation and solutions such as process parameter optimization using Design of Experiments (DoE), solvent and buffer system redesign and mechanical stress minimization.
The presentation will also explore how regulatory guidelines increasingly demand aggregation control strategies at the development, specification and stability stages of both drug substance and drug product.
This webinar is ideal for professionals involved in peptide process development, formulation, analytical sciences and regulatory affairs who want to deepen their understanding of aggregation-related risks and how to manage them across the development lifecycle.
Register for this webinar to learn how to identify, monitor and control peptide aggregation. Gain practical insights, technical approaches and regulatory-aligned strategies to ensure the quality, efficacy and manufacturability of peptide therapeutics.
Join experts from PolyPeptide Group, El Djouhar Rekaï, PhD, Head of Process & Analytical Development; Anaïs Pujol-Collinson, PhD, Downstream Process Scientist; and Dinesh Parmar, Head of Regulatory Affairs Ambernath, for the live webinar on Wednesday, June 18, 2025, at 10am EDT (4pm CEST/EU-Central).
For more information, or to register for this event, visit Peptide Aggregation in Manufacturing: Mechanisms, Challenges and Case Studies.
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