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

4-week online academy | 1 hour per week

15 July - 9 August 2019

Online Academy

Part of PTI’s new 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.

  • Examine how to determine the shelf life of a biotech protein product
  • Identify the key differences between biologics and small molecules
  • Learn best practice to establish and execute protein stability programs
  • Discover how to determine the stability indicating profile of a biotech and then how to validate those methods
  • Gain an insight into common concerns raised during inspections
  • Examine the difference between comparability and similarity
  • Assess analytical comparability throughout development for both innovator and biosimilar
  • Understand which analytical methods to use in comparability studies
  • Identify the common mistakes made during comparability studies

Dr Nadine Ritter is President and Analytical Advisor for Global Biotech Experts, LLC. She provides expertise in analytical test method selection and optimization for product characterization, release and stability testing; analytical test method qualification and validation, as well as pre- and post- approval product comparability studies, and assay bridging/technology transfers. In addition, she routinely performs third-party laboratory quality and compliance audits for small start-ups to multinational pharmaceutical corporations and contract testing laboratories.

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.

PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

Watch the Online Academy Video

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