Successfully Navigating the Analytical Environment of Complex Generic APIs

Oct 16, 2018

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A growing number of small molecule generic manufacturers are venturing into the world of complex generic APIs, such as peptides, polypeptides (e.g., glatiramer acetate), or complex polysaccharides such as pentosane polysulfate or enoxaparin. Even though they are chemically-derived, these complex molecules require a more complex and challenging analytical strategy than conventional APIs, in order to demonstrate their sameness.

This webcast will discuss the issues, and focus on:

- The regulatory environment for complex drugs and particularly for complex APIs

- Analytical package design, considerations, and pitfalls


Key Learning Objectives:

  • Get an update on the regulatory landscape for generic peptides and complex APIs
  • Understand the challenges presented by physicochemical sameness requirements for complex generics
  • Learn some of the common pitfalls encountered while developing an analytical sameness strategy


Who Should Attend:

  • Generic/Biopharmaceutical development, CMD, and QC scientists
  • Generic/Biopharmaceutical managers looking to outsource



Berangere Tissot, Ph.D., General Manager, SGS Life Sciences

Dr. Ajaz S. Hussain, Ph.D., Principal, Insight Advice and Solutions, LLC, President, National Institute for Pharmaceutical Technology and Education


Date and Time:

Live: Tuesday, 16 October, 2018 at 11 am EDT | 8 am PDT | 1600 BST | 1700 CEST

After the final airing of the webcast on 16 October, 2018 it will be available on demand until 16 October, 2019. 

Sponsor: SGS Life Sciences Services

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