Upcoming Live Webinars

Using SEC-MALS-IV to Characterize
PLGA for FDA Generic Drug Approval

Join us for a webinar on November 14 at 8:00 AM PST | 11:00 AM EST | 17:00 CET

Traditionally, size exclusion chromatography (SEC) with column calibration is used to obtain the molar mass distributions of polymers such as PLGA. However, this technique has significant drawbacks as it assumes the standards used for calibration are physically similar to the sample, of particular concern for copolymers and other non-standard macromolecules. In comparison, multi-angle light scattering utilizes first principles to obtain a truly accurate molar mass measurement. Combined with a differential viscometer to measure intrinsic viscosity (IV), SEC-MALS produces a bevy of useful information from PLGA analysis, including branching ratio and conformation.

Generic drug manufacturers must prove that the excipients in their formulations are the same as the excipients in the reference drug. SEC-MAL-IV is the ideal technique for this purpose due to its robust and comprehensive nature. In this webinar, we will discuss the theory and technology of SEC-MALS-IV, and the parameters it quantifies. Additionally, we will discuss the utility of SEC-MALS-IV in satisfying FDA regulations for production of generic drug formulations.

Recent Webinars

Previous webinars may be viewed in our Webinar Library. The following recent webinars are now available:

• Investigating Hydrogel Microparticles with Light Scattering and Microscopy Tools
• Multi-Detector SEC Characterization of Polymer Architectures
• Absolute Molar Mass Analysis of Medical Device and Pharmaceutical Polymers
• Structural Characterization of Biopolymers by Analytical Separation Techniques with Advanced Detectors
• Latest Advancements in Absolute Characterization of Proteins, Polymers and Nanoparticles
• The Next Generation in Light Scattering for the Characterization of Macromolecules and Nanoparticles
• Separation and Characterization of Macromolecular and Supramolecular Structures by Light Scattering
• Understanding Absolute Stoichiometry of Oligomeric Protein Complexes Using SEC-MALS
• Probing Submicron Protein Aggregation Using Asymmetrical Flow Field-Flow Fractionation (AF4) and Light Scattering
• The Importance of Light Scattering in Biopharmaceutical Formulation Development
• Predicting and Evaluating the Stability of Therapeutic Protein Formulations by Dynamic Light Scattering and Machine Learning
• A Quick Guide to Properly Measuring Zeta Potential and Particle Size for Challenging Samples
• Characterizing Protein-Nucleic Acid Interactions by Light Scattering
• FFF 2.0: Obtaining high resolution distributions of nanoparticle size and zeta potential
• Development of a New Online Micro-Viscometer for APC and UHPLC Applications
• Crystallized Biotherapeutics: Optimizing mAb Crystallization using Light Scattering
• Separation and Characterization of Complex (Bio)macromolecular Architectures
• Understanding monoclonal antibody unfolding and aggregation
• Applications of Light Scattering to HIV Integrase Structural Biology and Drug Discovery

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