Road to the clinic: how to translate your research into a manufacturing process

In this SPARK-BIH National Gene and Cell Therapies Webinar, Dr. Melissa van Pel will share her knowledge on process development, clinical manufacture and testing strategies for Cell Therapies.

 

MS Teams

Dr. Melissa van Pel

Dr. Melissa van Pel obtained her PhD degree at the University of Utrecht in 2003. After an academic career focusing on molecular, cellular, and functional aspects of hematopoietic- and stromal cell populations, Melissa’s work shifted towards Cell Therapy product development, process development, product characterisation and clinical manufacturing of Cell Therapies according to cGMP and other international standards.

In 2020, she joined NecstGen as Head of Cell Therapy where she contributed to the design, engineering and set-up of NecstGen. At NecstGen, Melissa is responsible for process development and clinical manufacture of novel Cell and Gene Therapy products.

This session will provide an in-depth analysis of process development. Process development aim is to translate a research-grade process into a GMP compliant manufacture method, which is robust and reproducible despite the donor-to-donor variations. During process development, key decisions should be made on the production process, testing strategy, target product profile and activities can be undertaken to challenge the cost of goods.

 

Online via MS Teams | Please register HERE!

This lecture series is part of the National Strategy for Gene- and Cell-based Therapies.
The organizers reserve the right to change and update the topics and speakers. 
All webinars with automatic captioning.

 

SPARK-BIH is a member of the SPARK Global network