Nanomedicine Development from Lab to Clinic: Strategies to Overcome Scale-Up and Analytical Challenges
Nanomedicine Development from Lab to Clinic: Strategies to Overcome Scale-Up and Analytical Challenges
Nanomedicines such as liposomes and polymeric nanoparticles offer versatile therapeutic applications, but their inherent complexity presents significant hurdles in development and manufacturing. Upscaling a promising formulation from lab bench to GMP manufacturing is rarely straightforward. At small scale, processes tend not to be optimized for robustness or reproducibility. As a result, many published nanoparticle syntheses cannot be easily adapted for a large-scale production, instead requiring entirely new synthesis strategies to be viable at scale.
Analytical development of nanomedicines is also challenging because of their multiple components (e.g., active ingredient, lipids, target moiety) and related impurities that need to be extracted from a complex matrix for quantification. Attributes such as free components, size, morphology and functional properties are also often critical and require robust methods early on to ensure reliable batch comparability. Standard pharmacopeial approaches are not sufficient to characterize in-depth these complex systems.
In this webinar, Ardena nanomedicine experts will explore the critical challenges in scaling up nanomedicine production and analytical development, where we present a few examples of commonly encountered hurdles as well as the strategies to deal with them.
Key Learning Outcomes:
• Understand key challenges in scaling nanomedicine formulations to GMP manufacturing.
• Learn how to redesign lab-scale processes for robustness and reproducibility.
• Explore analytical strategies for characterizing complex nanoparticle systems.
• Identify critical quality attributes to ensure batch-to-batch comparability.
Target Audience: Pharmaceutical scientists, formulation specialists, R&D professionals, heads of CMC, C-suite executives at emerging biotechs, and regulatory affairs experts. Anyone advancing nanoparticle-based drug products toward clinical and commercial phases will find valuable insights in this webinar.
Analytical development of nanomedicines is also challenging because of their multiple components (e.g., active ingredient, lipids, target moiety) and related impurities that need to be extracted from a complex matrix for quantification. Attributes such as free components, size, morphology and functional properties are also often critical and require robust methods early on to ensure reliable batch comparability. Standard pharmacopeial approaches are not sufficient to characterize in-depth these complex systems.
In this webinar, Ardena nanomedicine experts will explore the critical challenges in scaling up nanomedicine production and analytical development, where we present a few examples of commonly encountered hurdles as well as the strategies to deal with them.
Key Learning Outcomes:
• Understand key challenges in scaling nanomedicine formulations to GMP manufacturing.
• Learn how to redesign lab-scale processes for robustness and reproducibility.
• Explore analytical strategies for characterizing complex nanoparticle systems.
• Identify critical quality attributes to ensure batch-to-batch comparability.
Target Audience: Pharmaceutical scientists, formulation specialists, R&D professionals, heads of CMC, C-suite executives at emerging biotechs, and regulatory affairs experts. Anyone advancing nanoparticle-based drug products toward clinical and commercial phases will find valuable insights in this webinar.
