Conference Day Two | Thursday, July 25, 2024
8:00 am Morning Coffee & Networking
9:00 am Chair’s Opening Remarks
Peptide Power-Up: Optimizing Post-Translational Modifications and Polymorphism Downstream for Enhanced Product Stability & Efficacy
9:15 am Overcoming Complexity in Navigating Post-Translation Modifications of Synthetic Peptides
Synopsis
- Tackling the complexity of larger peptides which requires the careful consideration of secondary structures, stereochemistry, and incorporation of non-natural elements
- Balancing precision and integrity to achieve precise modifications while maintaining peptide structure integrity
- Incorporating reactive handles during synthesis streamlines post-synthetic modifications, facilitating diverse chemical transformations post-synthesis
9:45 am Understanding the Impact of Peptide Polymorphism on Downstream Process Development
Synopsis
- Exploring the diverse structural forms of peptides and how variations in conformational states can influence critical quality attributes (CQAs) and downstream processing parameters
- Discussing the challenges associated with polymorphism in peptide purification and proposing strategies to mitigate risks and ensure consistent product quality
- Addressing the regulatory implications of peptide polymorphism on drug development, emphasizing the importance of robust control strategies, analytical methodologies, and risk assessment frameworks to ensure product safety, efficacy, and compliance
10:15 am Break & Networking
Strategies for Mitigating Impurities and Aggregates in Peptide Development: Proactive Monitoring to Minimize Immunogenicity Risks
11:00 am Mitigating Aggregation & Contaminant Risks in Peptide Process Development: Strategies for Enhanced Manufacturing Efficiency and Product Quality
Synopsis
- Focusing on minimizing aggregation during downstream processing and fill & finish operations, while also monitoring physical stress and implementing control measures to prevent aggregation
- Developing and implementing relevant analytical and orthogonal characterization methods to characterize aggregates and particulates
- Monitoring and evaluating Extractables and Leachables (E&Ls) from manufacturing equipment and container-closure systems to minimize potential toxicity and immunogenicity risks associated with genotoxic and carcinogenic substances
11:30 am Immunogenicity Risk Assessment of Synthetic Peptide Drugs & Their Impurities
Synopsis
- Peptide drugs serve vital therapeutic roles across medicine, with over 80 approved for human use, careful monitoring of impurities must be implemented
- FDA proposes of new pathways like the Abbreviated New Drug Application (ANDA) to hasten access to generic peptide drugs, emphasizing the need to monitor and disclose new impurities due to potential immunogenicity risks
- EpiXav is uncovering the framework for assessing the immunogenicity risk of various bioactive peptide products, crucial for ensuring the safety and advancing peptide drug development
12:10 pm Lunch
Critical CMC Regulatory Considerations in Peptide Development: Ensuring Quality, Safety, & Efficacy
1:10 pm Navigating Peptide Process Development for Cell Therapy: From Mechanism of Action to Clinical Realization
Synopsis
- Understanding the process of eliciting specific T cells through peptide-based cell therapy, outlining its framework and potential impact
- Bridging Preclinical Data to Clinical Trials: Bridge between the preclinical data to the clinical trials, showcasing key learnings that led to process optimization
- Unveiling the intricacies of manufacturing peptides for cell therapy, detailing the manufacturing process, release testing, and encountered challenges, offering valuable insights for navigating CMC hurdles
1:40 pm Peptide Regulatory Odyssey: Navigating CMC Compliance Across Europe & the US
Synopsis
- Delving into the regulatory dichotomy: Understanding how peptides, commonly treated as biologics in Europe, are categorized as small molecules by the FDA, demanding a multifaceted approach to CMC adherence
- Tackling critical considerations like impurities, stability, process validation, and analytical methods validation, aligning with small molecule CMC directives while upholding biologic quality standards
- Implementing tailored strategies to navigate regulatory expectations, including robust risk assessment, comprehensive characterization studies, and proactive engagement with regulatory agencies, to streamline CMC approval for peptide therapeutics
2:10 pm Break
Manufacturing Optimization in Peptide Production: Sustainable Practices & Scalability
2:40 pm Process Mass Intensity (PMI): A Holistic Analysis in Current Peptide Manufacturing Processes, Informing Sustainability in Peptide Synthesis
Synopsis
- Comparison of PMI across various manufacturing methods, including solid-phase peptide synthesis (SPPS) and liquid-phase peptide synthesis (LPPS)
- Identifying key areas for process optimization, including purification strategies and solvent selection
- Examination of solvent usage and exploration of solutions to mitigate environmental impact while maintaining process efficiency and product quality
3:10 pm Revolutionizing Bioprocessing for Miniproteins: Maximizing Yield & Scaling for Clinical Success
Synopsis
- Exploring the unique challenges and opportunities associated with developing bioprocessing systems tailored for novel constrained peptides
- Discussing innovative approaches and methodologies for maximizing yield, including optimization of expression systems, fermentation conditions, downstream processing techniques, and purification methods tailored specifically for these novel molecules
- Addressing the critical considerations and strategies for scaling up constrained peptide bioprocessing from laboratory-scale production to clinical-grade manufacturing, ensuring consistency, quality, and regulatory compliance for successful translation into clinical trials