Particles in Biologics: Advanced Analytics and Tech Transfer

For many teams, particles and aggregates are treated as a late-stage compliance headache or a sudden fire drill during manufacturing. But what if we looked closer? Particle populations can actually reveal deep insights about your formulation stability, process robustness, and potential technology transfer risks long before you reach commercial scale.In this episode of Life Science Solutions, host Chris Adkins sits down with Dr. Tim Menzen, Chief Technology Officer at Coriolis Pharma, a science-driven CRO specializing in formulation development and advanced analytics for biopharmaceuticals. With a PhD focused on the thermal unfolding and aggregation of monoclonal antibodies, Tim brings a wealth of expertise to the evolving landscape of biologic particles.If your organization is looking to modernize how it approaches formulation and process development, this conversation is packed with cutting-edge insights.Topics Include:The Evolution of Antibodies: How improved molecular engineering has shifted the industry away from from-scratch formulation and toward streamlined "formulability assessments".Tech Transfer Risks: Why pumps are famously considered "particle generating machines," and why true like-for-like process transfers rarely exist.Subvisible vs. Visible: Why waiting for visual particles is like ignoring a flashing red light, and how characterizing submicron particles early helps identify root causes.Orthogonal Analytics: Moving beyond traditional pharmacopeia methods (like sizing and counting) to determine exact particle morphology, such as distinguishing a silicone oil droplet from a fluffy protein aggregate.Particle Fingerprinting: How flow imaging microscopy and AI are being used to create two-dimensional "fingerprints" to compare the morphological density of particles across different processes.The Future of Formulation: What’s next on the horizon, including in silico computer simulations, multi-dimensional data instruments, and assay miniaturization to save valuable drug material.This episode is designed for CSV, CQV, and QA professionals who want a clearer, more efficient approach to validation, supported by real risk based thinking.🎧 Subscribe to Life Science Solutions wherever you get your podcasts, and share this episode with your quality, validation, and IT teams!📍 Recorded at Kymanox HQ in Research Triangle Park, North Carolina.