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.
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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
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5