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Starts 28 October 2019
Online Academy,
6 module series over 4 weeks

Product Specifications, Stability, Comparability and Similarity for CMC Analytical Studies

Learn best practices for ensuring the quality and efficacy of your products on this online course.

Part of the Biopharmaceutical and Biosimilar CMC Analytical and Lab Quality Series

Course Overview

Part of the online biopharmaceutical and biosimilar CMC analytical series, this course will provide you with a complete understanding of biotech stability and comparability studies. Both studies are crucial for biopharmaceutical and biosimilar development and this 4-week course will provide you with the knowledge and competency to establish and execute programs effectively to ensure the quality and efficacy of your products.

You will learn to identify stability profiles for proteins and validate these methods through stability studies, and then how to overcome challenges to establishing similarity for reference and biosimilar products through comparability studies.

What will you learn?

Shelf life

Examine how to determine the shelf life of a biotech protein product

Key differences

Identify the key differences between biologics and small molecules, and examine the difference between comparability and similarity 

Protein stability programs

Learn best practice to establish and execute protein stability programs and discover how to determine the stability indicating profile of a biotech

Analytical comparability

Assess analytical comparability throughout development for both innovator and biosimilar and understand which analytical methods to use in comparability studies

Overcome challenges

Gain an insight into common concerns raised during inspections and identify the common mistakes made during comparability studies

Who is this course for?

This course is primarily aimed at professionals working in biopharmaceutical analytical CMC (CMC biologics). The materials are also appropriate for regulatory, project management and bioprocess professionals wanting to broaden their knowledge in CMC biologics.