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.
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.
Once you have registered you will be given login details to access the course