Light scattering-based solutions for excipients and advanced formulations
Excipients are inactive substances used in drug formulations alongside the active pharmaceutical ingredient (API). They serve important functions, such as stabilizing and solubilizing the API and facilitating drug absorption, delivery, and release. Macromolecules and nanomaterials are often employed as excipients in complex formulations, particularly for emerging therapeutic modalities. For these excipients, molecular weight, size, and conformation are crucial in achieving their intended functions.
In this webinar, we will showcase case studies demonstrating how multi-angle light scattering (MALS) detection following size exclusion chromatography (SEC) and field flow fractionation (FFF) are utilized to characterize, quantify, and deformulate these advanced excipients and formulations.
Key Learning Objectives:
- Learn key quality attributes of complex excipients based on polymers and nanomaterials.
- Explore dynamic light scattering (DLS), SEC-MALS, and FFF-MALS for in-depth characterization of complex excipients.
- Discover tips and tricks for using LS-based techniques in reverse engineering and deformation.
Who Should Attend:
- Scientists and managers working with excipients and advanced formulations.
- Generic drug developers looking for solutions to demonstrate bioequivalence.
- Regulatory specialists seeking improved methods to characterize polymers and nanomaterials used in therapeutic products.
- CXOs exploring new business opportunities.
Presenter: Michelle Chen, Ph.D (Waters | Wyatt Technology)
Dr. Michelle Chen is a senior director at Waters | Wyatt Technology. She has over twenty years of experience in biopolymers and nanoparticle characterization using light scattering coupled to SEC and FFF. In recent years, Michelle has led the application team at Wyatt Technology to develop novel methods to characterize and quantify emerging therapeutics and delivery vehicles including new protein conjugates, viral vectors, lipid nanoparticles, and extracellular vesicles.