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

Course summary
4 weeks
Online courses
Professional Training

Course description

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

The final course in the online biopharmaceutical and biosimilar CMC analytical series. This course follows on from course 1 on regulatory challenges and course 2 on methods and reference standards. 

Part of Bioprocess International Academy's new online biopharma/biosimilar CMC analytical series this course has been designed to 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 both study programs. 

The course will help you identify protein stability profiles, through the comparability element will provide you with experimental design tips to help you overcome the challenges when developing biopharma/biosimilar products.

Suitability - Who should attend?

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.

Outcome / Qualification etc.

  • 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

Training Course Content

  • Module 1 - 3 : Establishing Specifications and Executing Stability Programs for Drug Substance and Drug Product
  • Module 4 - 6 : Analytical Elements of Comparability Studies and Similarity Studies: Experimental Designs and Challenging Considerations

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About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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