GMP-compliant CAR T cell manufacturing training course

Information for applicants

CARAT is a EU-funded project aiming to integrate innovative cell manufacturing technologies into a new, comprehensive platform that will facilitate the safe, automated, and cost-efficient manufacture of highly effective CAR T cells. Thus, CARAT is taking on the mission to deliver new methods to enable the wide use of novel personalized cancer treatment options based on highly innovative cell therapies. The project consortium comprises a multi-national team of leading experts from eight European partnering institutions.

In 2017 a first unique training event was performed by CARAT to transfer knowledge on GMP-compliant CAR T cell manufacturing to scientists in the field. Based on the high interest and the huge success of 2017’s training event, CARAT will offer a second training event in 2018 to reach an even higher number of scientists. The course is limited to a maximum of five attendees. It will take place at Miltenyi Biotec´s headquarter in Germany in December 2018 and focuses on practical, regulatory, and scientific issues. Applicants from EU Member States and Associated Countries are encouraged to participate.

Target group

Scientists with a profound background in cellular and gene therapy, who intend to initiate clinical applications in the near future.

Date and location

The training event will take place on December 10-14, 2018 in Bergisch Gladbach, Germany.

The objectives of this training event are:

• To introduce the cell separation technology on the CliniMACS Prodigy Platform
  
• To deliver the versatility and limitations of the current T cell transduction (TCT) process
  
• To enable the trainee to perform independently automated manufacture of cellular products: all process phases, such as selection, activation, transduction, and expansion are explained/demonstrated with special regard to user interaction and process versatility
  
• To enable the trainee to handle common situations of the TCT process like GMP logistics, monitoring, basic troubleshooting
  
• To deepen practical expertise via extensive hands-on exercises
  
• To discuss regulatory requirements like trial design, approval or IMPD (Investigational Medicinal Product Dossier)

The fellowship will include:

• Training materials (presentations and exercises), usage of equipment and consumables
  
• Catering during the course
  
• One hosted dinner
  
• Hotel accommodation (five nights)
  
• Transportation between hotel and MACS® Academy
  
• Travel expenses up to 500€/pp
  
• Certificate of completion

Location

MACS Academy at Miltenyi Biotec Headquarters
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach 
Germany

Application structure and submission

1. Submission deadline for applications: June 30, 2018. Applications should be sent electronically in a single pdf document to Janine Jost (j.jost@eurice.eu).

2. Applications must be written in English and should provide the following information:

• Motivation for wanting to take part in the training event (maximum length: 1 page, font size 11)
  
• Short Curriculum Vitae (CV) (maximum length: 1/2 page, font size 11)
  
• References: most relevant own publications (maximum length: 1/2 page, font size 11) NB: Copies of publications and letters of recommendation are not required and should not be submitted. The total application should not exceed 2 pages.

Selection criteria

All applications will be reviewed based on the following criteria:

• Scientific background of the applicant (reference to cell therapies/planned clinical applications of cell/gene therapy in the near future)
  
• Gender balance and regional aspects

Selection procedure

Submitted applications will be peer-reviewed by the CARAT Steering Committee (composed of the Work Package Leaders and one representative of TrakCel and Eurice), taking into account scientific aspects as well as gender equality and regional aspects.

The applicants will be informed about the outcome of the evaluation process 3 months after the application deadline at the latest.

CARAT reserves the right to adapt the timelines of the procedure in case of unexpected events.