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

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  November 14, 2019

  8:00 a.m. PST, 11:00 a.m. EST, 16:00 GMT, 17:00 CET

 

Overview

 

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.

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Key Learning Objectives

  • Overview of SEC-MALS-IV and instrumentation used in the technique
  • The key parameters obtained from SEC-MALS-IV characterization of PLGA
  • How to compare PLGA derived from a commercial drug to a PLGA standard

Who Should Attend

  • Staff scientists involved in the characterization of PLGA and other polymeric excipients.
  • Pharmaceutical product managers developing generic drugs that contain polymers such as PLGA.
 

Speaker

Chris Deng, Ph.D.
Application Scientist,
Wyatt Technology
 

Moderator

Alexandra Taylor
Assistant Editor,
C&EN
 

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