Cell Therapy - Tools for process development and GMP manufacturing

This is a two day training course on essential tools, techniques and regulatory guidelines for cell based medicinal products manufacturing, process development and

Duration
2 days
Course fee
€ 1795 (excl. VAT)

Short description

This training will be planned after the summer holidays so keep an eye on our website.

The modules of this course are highly interactive and have a focus on practical implications.

Approximately 50% of the modules contain  practical activities.

The main topics covered are:

  • Regulatory framework applied to ATMPs (advanced therapeutic medicinal products)
  • Quality controls & documentation for cell based medicinal products
  • Manufacturing processes  
  • Cell characterization & quality control methods for cell based medicinal products

This course is organized in cooperation with Thermo Fisher Scientific.

Objectives

  • Gain understanding of regulatory  guidelines for ATMPs and practical implications thereof
  • Learn about the specific characteristics of cells and their manufacturing processes
  • Find out more about how quality control methods for cell based medicinal products
  • Acquire more knowledge of how to and why transfer processes to close set-up
  • Get practical experience in single use technologies
  • Gain hands-on experience in cell visualization and cell counting
  • Gain practical insights into cell separation, bioreactor culture (rocker) and flow cytometry

Target group

Production support, process development, analytical development or QC technicians as well as researchers of hospitals or translational centers that want to learn more about tools, techniques, regulations and guidelines in cell therapy products manufacturing.

Program

Day 1

 

• GMP for ATMPs - The essentials
• Cell Therapy Manufacturing Concepts
• Basics for cell based medicinal product manufacturing (hands-on)
• Closed systems, cell separation, rocker bioreactor, cell visualization and cell counting
• Social event

Day 2

 

• Regulatory framework application to ATMP
• Contamination control and cleanrooms
• Cell Characterization and quality control
• Flow cytometry
• Quality control tools and techniques

Sign up

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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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