Agenda items

12 - 14 December 2022

Analytical procedures fit for decision making

Are you ready for the new and upcoming ICH Q14 and USP <1220> guidelines and the complementary revision (R2) of ICH Q2? These forthcoming guidelines are designed to fill a void in the toolbox of analytical method development. They provide the opportunity to present the scientific framework build during development in the validation reporting of the analytical methods. By following and implementing these guidelines and appropriate tools, authorities will facilitate efficient and risk-based approval of analytical methods with flexibility for post-approval changes and keeping product and process control strategies scientifically sound and fit-for-purpose. The guidelines are almost ready, and this promising and desired tool? Analytical Quality by Design.

Analytical methods are employed throughout pharmaceutical development and manufacturing. They provide data, translated into information, to make decisions. This decision-making process should be science-centered to acknowledge the uncertainty of a measurement and risk of making the wrong decision. Analytical Quality by Design (AQbD) is a structured risk-based approach that supports the process of effectively designing analytical procedures that focus on the intended purpose and fulfil the anticipated requirements. This approach extends beyond the application of design of experiments, or even the method on its own.

The process starts with predefined objectives and a handshake between project and the analytical department, includes identifying critical method parameters, risk-based decision making and continuously following and improving your procedure. The resulting method is better understood, more robust and in control. This reduces the need for troubleshooting and costly reanalysis. The knowledge and decisions made during development are captured, shareable and reusable throughout the whole pharmaceutical life cycle.

See here for the 2022 brochure.

For whom

This course aims at managers and scientists who want to apply a scientific AQbD approach in their daily work or gain knowledge on how to start implementing AQbD within their organization.

Course content

  • Theory on Analytical Quality by Design
  • Detailed training on the AQbD flow and the specific modules:
    • Analytical Target Profile
    • Technologies selection
    • Critical Method Parameter
    • Method Development
    • Implementation
    • Method Verification
    • Procedure life cycle management
  • How to implement AQbD within your organization
  • Hands-on practice for each module
  • Rapid learning cycles by combining theory and exercises
  • Discussions in an open and positive environment
  • Real examples and experiences from industry
  • Template you can adapt for your own organization

Learning outcome

This 3-day course will provide time to network and discuss with fellow scientists. After this course you have learned how to apply AQbD in your daily work and are motivated to start implementing this approach within your organization. A training certificate, practical templates and hand-outs will be provided.

The trainers

The training will be provided by Cari Sänger - van de Griend (Kantisto), Ewoud van Tricht (Janssen), Lars Geurink (Janssen), and Eline van den Berg (Byondis). We share years of experience applying and implementing the principles of AQbD within our companies. By incorporating AQbD in our method development process, we improved the interconnection between analytical methods and the process and quality profile of our product, strengthening the concept of “right analytics at the right time”. AQbD increased our level of control and understanding of the analytics as well as reduced our developmental costs and time.

Registration

The next course is planned for 12 - 14 December 2022 in Naarden-Bussum (25 km from Amsterdam). For more information and registration, contact Kantisto. There is a maximum of 20 attendees, make sure you register in time! Refund policy: written cancellation before 1 October 2022 will result in a full refund minus a 20 % processing fee. Cancellation made after 1 October 2022 will not be refunded, but registration can be transferred to another person.

Kantisto also offers on-site consultancy, implementation support, and courses with content tailored to your needs.

Please send an e-mail or use Kantisto's contact form.

Feedback from previous courses

  • Everyone in our organization should do this course. Many applicable solutions were discussed in a comprehensible way that we can apply immediately. 
  • The course covers the fundamentals of the AQbD and it gives the courage to try it for yourself.
  • My basic knowledge about AQbD was mostly on DoE robustness. I now feel secure that the course helps me to support my group in every AQbD subject.
  • The course made me better understand the whole workflow and the relationship between all different steps.
  • Many practical examples that give grip on the topic. The exercises clearly demonstrated and underlined the need for an AQbD mind set.
  • The teachers had a good balance, they have lots of experience and complement each other.
  • There was plenty of opportunity to ask questions and the speed of the training was flexible and adapted to our uptake.
  • I have really enjoyed this course and look forward to use all that I’ve learned to my method development at work. Thank you very much!

Feedback from previous courses.

Available on request

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 2020 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

If you wish to 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.

7 - 9 November 2022

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 2022 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 next course is planned for 7 - 9 November 2022. Please contact Kantisto if you are interested in this course or in a similar course for/at your company.

Kantisto 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.