Agenda items

4 - 6 Nov 2019. This course provides you with Capillary Electrophoresis (CE) fundamentals and operating modes, as well as practical tips to obtain fit-for-purpose methods. The method validation focuses on the ICH Q2 guideline, with many real-life examples from the pharmaceutical and biotech industry. Troubleshooting combines fundamental understanding with pragmatic problem solving and prevention. Although the focus is on (bio)pharmaceuticals, the principles apply for most CE methods.

See here for the 2019 brochure.

For whom

This course aims at scientists with some hands-on experience in CE and who want a better understanding of the CE techniques and are looking for practical tips for method development and validation, good working practices and troubleshooting.

Learning outcome

After this course, you will have a deeper understanding of the fundamentals and be able to couple method development and validation to the purpose of your analysis. You will be better able to develop robust, precise and sensitive methods and will have a better understanding about the critical parameters, AQbD and good working practice of CE. You will have a good understanding on the validation parameters from a CE point of view as well as from a patient safety perspective. You will be able to make a to-the-point validation protocol. Your gain in knowledge will reduce the amount of troubleshooting needed in daily practice, but if needed you will know what to do.

Course content

  • The separation mechanism
  • Different modes of CE, including CZE, CGE and cIEF
  • CE method development
  • CE instrumental aspects and Good Working Practices
  • Analytical Quality by Design and Design of Experiments
  • Method validation purpose and phase-related approach
  • ICH Q2 guideline for analytical method validation
  • Troubleshooting strategy
  • Preventing the need for troubleshooting

Feedback from previous courses.

Registration

The 2019 course takes places 4 - 6 November 2019 in Naarden-Bussum, close to Amsterdam. Early bird reduced fees until 1 July 2019. Deadline for registration 1 October 2019. After 1 October, only after contact with Kantisto and based on available space. Minimum attendance 5 people, maximum 15 people. Refund policy: Written cancellation before 1 Aug 2019 will result in a full refund minus 20 % processing fee. Cancellations made after 1 Aug 2019 are not refundable, but registration can be transferred to another person. More details in the brochure. Course fee includes three hotel nights and breakfast, lunches, course dinner and course hand-outs.

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.

When we learn how to develop an analytical method, we learn to pay attention to all the technical details. However, methods that are intended for extensive use need to meet more criteria than e.g. providing a good separation. What is phrased in the pharmaceutical industry and by regulatory bodies as “adequate for intended purpose” encompasses a lot of different requirements on top of the technical ones. In this course we learn that Analytical Quality by Design (AQbD) is a tool that supports the process to design and deliver a method that fulfils all the requirements. AQbD additionally helps to actively manage the method through its life cycle in the (bio)pharmaceutical industry.

See here for the 2019 brochure.

For whom

This course aims at scientists that want to develop and implement AQbD in their labs or that want to apply an AQbD approach in their daily work.

Learning outcome

After this course, you will have a better understanding of the why and the how of analytical quality by design. You will be able to use this AQbD tool in your method development and focus on the purpose of the methods. You will get practical and pragmatic tips on how to implement AQbD in your organization.

Course content

  • Analytical Quality by Design purpose and process
  • Analytical Target Profile
  • Technique choice
  • Critical Method Parameters, Criticality and risk assessments
  • Method development, optimisation and validation
  • Multifactorial Design of Experiments
  • Method application and life cycle management
  • Examples from industry

Feedback from other courses.

Registration

The 2020 dates will soon be available. For more information and pre-registration, 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.

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.

For whom

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.

Learning outcome

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.

Course content

  • 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

Feedback from previous courses.

Registration

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.

This is a practical on-site training on the daily use and work flow with ChemStation software for Agilent 1600 or 7100 Capillary Electrophoresis instruments.

Please contact Kantisto for further information.

The content of this training will be fine-tuned in consultation with the participants. The fundamentals on electrophoresis and electro-osmosis theory and different CE modes are refreshed and attention is paid to Good working practice on CE, the troubleshooting process, preventing troubleshooting and case studies. Training on-site, on-the-job, if requested.

For more information, costs, registration and planning,  please contact Kantisto.