ATMP Manufacturing, From Process Development to the Patient

Gain a thorough understanding of manufacturing cell-based medicinal products, specifically Advanced Therapy Medicinal Products (ATMPs), with our comprehensive course.

Duration
2 days (9:00 - 17:00)
Course fee
€ 1895 (excl. VAT)

Short description

Get up to speed on the essential elements of ATMP production, including the regulatory framework, quality control and documentation processes, manufacturing techniques, cell characterization and quality control methods.

This dynamic course is designed with an emphasis on interactivity and practical application, with approximately 50% of its modules incorporating hands-on activities in our state-of-the-art "ATMP manufacturing suite and QC laboratory", built in partnership with Thermo Fisher Scientific.

Objectives

By the end of the training you will be able to:

  • Describe the processes involved in production, testing, and release of cell-based products
  • Define the potential risks associated with the production of cell-based products
  • Gain knowledge on regulatory guidelines involved in the manufacturing of cell-based products
  • Demonstrate hands-on expertise through extensive practical experience using manufacturing and quality control equipment within our facility
  • Identify the challenges associated with the supply chain of cell-based products

Target group

Individuals involved in the development and production of cell-based therapies, including those working in quality control, quality assurance, production, research and development, as well as hospital researchers and staff of translational centers seeking to expand their knowledge of tools, techniques, regulations, and guidelines in the manufacture of cell therapy products.

If you are working in a different field or if you have questions about the suitability of this training for you, please contact us:

info@biotechtrainingfacility.nl

+31 (0)88 2830100

Program

Day 1 (09:00-17:00)

 

Theory

• GMP for ATMPs – the essentials
- what are ATMPs
- autologous vs allogeneic cell therapies
• Regulatory framework application to ATMP
• Cell therapy manufacturing concepts
- manufacturing steps
- closed vs open systems and challenges

 

Practice and Workshops

• Practice with (Thermo Fisher) equipment such as Gibco™ CTS™ Rotea™ Counterflow Centrifugation System, DynaCellect Magnetic Separation System and CTS Xenon Electroporation Instrument in our facility
• Closed systems, cell separation, rocker bioreactor, aseptic connections, welding

Day 2 (09:00-17:00)

 

Theory

• Quality control testing of ATMPs
- In-process controls
- Release testing
• Release of ATMPs
- Regulatory framework and considerations

 

Practice and Workshops

• Quality control testing of ATMPs
- qPCR, digital PCR, flow cytometry, cell counting

Sign up

Interested in signing up a group of people for this course?

Please contact our Business Development team:
info@biotechtrainingfacility.nl
+31 (0)88 2830100

Knowhow.
Know how.
Know why.

Need help? Have a question or a suggestion maybe?

Drop us a line below or call us on
+31 (0) 88 283 01 00.

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