When Unexpected Particles Threaten Your Biologic
Unexpected particulate contamination poses significant threats to biologic product quality, patient safety, and regulatory approval timelines. Resolving these contamination events requires determining the particle’s identity, tracing its origin, and evaluating safety risks with high scientific confidence. Implementing clinical in-use studies alongside advanced particle forensic tools—such as Raman spectroscopy, FTIR-ATR, and SEM-EDS—enables drug development teams to perform robust root-cause analysis and gather regulator-ready evidence. Combining sophisticated analytical techniques with centralized data platforms streamlines investigations, accelerating decision-making and preventing costly development delays. Establishing a science-backed, risk-focused investigation strategy empowers organizations to protect product integrity, clear compliance hurdles, and communicate transparently with regulatory bodies.
Access the full presentation to discover advanced strategies for diagnosing and mitigating particle risks in biologic programs.
Speakers: Kylee Harris, Scientist II, Biophysical and Particle Characterization Core, KBI Biopharma
Kylee holds a degree in Chemical and Biological Engineering from Colorado State University and has been with KBI since 2022. She specializes in clinical in-use studies, particle characterization, and IV bag/device compatibility testing, supporting the development of gene therapies, ADCs, and protein therapeutics. Passionate about patient safety, she helps ensure drug products are both effective and ready for clinical use.
Madison Connor, Scientist II, Biophysical and Particle Characterization Core, KBI Biopharma
Madison earned her degree in Molecular, Cellular, and Developmental Biology from the University of Colorado Boulder and has been with KBI since 2018. She specializes in particle characterization and forensic particle analysis, using advanced techniques to identify particulate matter and support drug product quality, manufacturing improvements, and patient safety.
Sarah Dickerson, Ph.D., Director, Biophysical and Particle Characterization Core, KBI Biopharma
Sarah earned her Ph.D. in Biochemistry from the University of Colorado Boulder and brings more than 10 years of industry experience, primarily in gene therapy. She specializes in analytical development, product characterization, and CMC strategy, helping clients implement robust early characterization approaches that reduce development risk.