Over 95% of BLAs submitted today contain CE methods for characterization and/or release. This course demystifies the secrets of what happens inside a CE capillary and explains the fundamentals and operating modes of capillary electrophoresis from the ground up, with a special focus on biopharmaceutical applications. The influence of key operating parameters and good working practice will be discussed. The method validation focuses on the ICH Q2 guideline, with many real-life examples from the pharmaceutical and biotech industry.
See here for the 2019 brochure.
This course aims at scientists and technicians that want a better understanding of the technique, or that want to implement or start with CE and want to be well prepared.
After this course, you will have a better understanding of the basics of capillary electrophoresis and several of its working modes and you will be able to select the right CE mode to the purpose of your analysis. You will have a better understanding about the good working practice and critical method parameters of biotech applications. You will have a good understanding on the validation parameters from a CE point of view as well as from a patient safety perspective and you will be able to make a to-the-point validation protocol. Your gain in knowledge will increase the success rate of implementing capillary electrophoresis in the (bio)pharma lab.
- Separation mechanism: what happens inside a capillary
- Different modes of CE, including CZE, CGE and cIEF
- CE instrumental aspects and Good Working Practices
- Platform methods and AQbD method development
- Method validation purpose and phase-related approach
- ICH Q2 guideline for analytical method validation
The 2020 course dates will soon be available. If you wish to pre-register, contact Kantisto.
Kantisto also offers on-site consultancy and courses with content tailored to your needs. Please send an e-mail or use Kantisto's contact form.