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.
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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.
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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.
- API/Formulation Development ,
- Basic Research ,
- Bioanalytical Testing ,
- Biologic ,
- Biologics ,
- Biologics Development ,
- Biologics Manufacturing ,
- Biomanufacturing ,
- Bioprocess Development ,
- Biosimilars ,
- CDMO/CMO ,
- Commercial Manufacturing ,
- Drug Development ,
- Laboratory Technology ,
- Peptide ,
- Peptide Synthesis ,
- Peptides ,
- Process Development ,
- Quality ,
- Regulatory ,
- Therapeutic Peptides
Speakers
El Djouhar Rekaï, PhD, Head of Process & Analytical Development, PolyPeptide Group
Dr. El Djouhar Rekaï is Head of Process & Analytical Development at the PolyPeptide Braine-l’Alleud site in Belgium. She was born in Paris and obtained her PhD in Organic Chemistry (focusing on sugar chemistry) from Pierre and Marie Curie University in 1997. Then, she took up a post-doctoral position in Polymer Chemistry at the Université Catholique de Louvain in Belgium from 1998 to 1999. In January 2000, Dr. Rekaï started as peptide R&D Chemist at UCB Bioproducts. Then, she specialized in chemical up-scaling and process validation before taking on the role of the overall development process and manufacturing process to cover all the clinical phases from R&D to commercial stages at PolyPeptide (former Lonza and UCB Bioproducts).
Message Presenter
Anaïs Pujol-Collinson, PhD, Downstream Process Scientist, PolyPeptide Group
Dr. Anaïs Pujol-Collinson is a Downstream Process Scientist at the PolyPeptide Braine-l’Alleud site in Belgium. She obtained her PhD in Bio-inorganic Chemistry from Grenoble University in 2010. With over 10 years of experience in manufacturing and R&D, Dr. Pujol-Collinson is an expert in peptide and aggregation analysis, particularly with amyloid-type peptides. She has established and led biophysics teams, focusing on peptide aggregation analysis using techniques such as, but not exhaustive, DLS, FTIR, SEC, CD, Fluorescence. Her contributions have significantly advanced the understanding of structure-activity relationships and the development of formulations for biologics in pre-clinical studies. Additionally, she has experience working with biologics, including antibody-drug conjugates.
Message Presenter
Dinesh Parmar, Head of Regulatory Affairs Ambernath, PolyPeptide Group
Dinesh Parmar has 16+ years of working experience in API regulatory affairs and has been associated with PolyPeptide Group for the last four years. In his career, he has filed 50+ US FDA DMFs and worked on critical deficiencies from various health authorities, including but not limited to those from the US, EU, Canada, China and South Korea. His expertise in product life cycle management has helped organizations strategize future changes in an effective manner, bringing quicker consensus with customers and faster approval with regulatory agencies, which results in smooth product commercialization. He believes regulatory intelligence is key for business continuity and aids in keeping organizations ahead of the curve.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Process development scientists in the peptide industry
- Analytical and formulation development teams working with peptides
- CMC and technical operations professionals focused on peptide therapeutics
- Quality assurance and quality control specialists in peptide manufacturing
- Regulatory affairs and compliance experts for peptide drug development
- Research scientists studying peptide structure, stability or aggregation
- Biopharmaceutical manufacturing professionals in peptide production
- R&D project managers and team leads overseeing peptide programs
- Biotech and pharma executives developing peptide-based therapeutics
- CDMOs supporting peptide synthesis and scale-up
- Technology transfer and scale-up engineers in peptide processing
- Academics and researchers investigating peptide aggregation
- Consultants advising peptide drug development and manufacturing
What You Will Learn
Participants will:
- Understand the mechanisms and types of peptide aggregation during manufacturing
- Learn how to detect and characterize aggregates using orthogonal analytical tools (SEC, DLS, FTIR, TEM and more)
- Explore case studies demonstrating practical strategies to overcome aggregation
- Gain insight into regulatory expectations for aggregation control in peptide therapeutics
Xtalks Partner
PolyPeptide Group
PolyPeptide Group is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India.
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