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Examine Phase-Appropriate Regulatory, Technical and Quality Elements for Characterisation, Comparability, and Control Strategies
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Biological therapeutics and vaccine products require an array of analytical methods to characterise their biomolecular structure and biological functions. The CMC elements needed to support product safety and efficacy are defined in a diverse array of regional and global regulatory guidances. The molecular complexity of each biological product dictates the analytical technologies necessary for its characterisation, comparability, and control strategies. But all biological product modalities require similar types of CMC analytical studies and key analytical data sets during development.
This introduction to CMC analytics for biologics, cell & gene and biosimilars course will provide you with a comprehensive overview of the phase-appropriate analytical expectations for biological products of any type (novel or biosimilar protein therapeutics, well-characterised or classic vaccines, advanced cell or gene therapies). Once completed, you will understand which analytical studies are needed, why they are important, and where to find technical guidance for your specific product modality. You will learn the most common mistakes made in method lifecycle elements, reference standard management, stability programs and comparability studies, and how to avoid them, especially under highly accelerated CMC timelines.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.
There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.
Learn more about the course by toggling through the tabs below (trainer, agenda, who should attend?)
We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.
For more information you can email us at [email protected] or call +44 (0) 203 111 7357.
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* | • The training course is delivered either online or in a classroom. Please check which course format you have booked. |
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