Sep
21
2021
On demand

Get your non-viral T cell engineering process ready for clinical manufacturing

In the past few years cell therapies had a major breakthrough due to the enormous success of chimeric antigen receptor (CAR) T cells in liquid cancer treatment. Since then the field of cell and gene therapy has rapidly evolved and numerous novel approaches are being investigated. One important challenge is surely the optimization of CAR T cell products in regards to potency, safety and persistence. In addition, the concept of using allogeneic off-the-shelf CAR T cell products to cut down vein-to-vein time and manufacturing costs is becoming more and more attractive. Last but not least, genetically modified T cells are also currently being investigated as treatment option for several other indications.

All of these revolutionary new approaches in cell and gene therapy require complex multi-step gene-engineering, which strongly emphasizes the need for non-viral gene modification options in addition to the currently popular viral strategies. However, translation of such a complex research workflow into a GMP environment still represents a major challenge, and perhaps even a breaking point in novel cell therapy development.

  • How to close and automate your T cell electroporation protocol to get it ready for clinical manufacturing      
  • How complex gene modifications are enabled bythe combination of electroporation and transduction
  • How to tackle challenges during process development and translation into clinical manufacturing

Melanie Rietenbach

Global Product Manager, Miltenyi Biotec

Melanie Rietenbach is Global Product Manager for the clinical engineered cells portfolio including CAR T and CAR NK cells at Miltenyi Biotec. During the past year, she has been working together with the R&D and Clinical Development Team in order to advance the development of tools to enable CAR T and CAR NK cell immunotherapy. Before that, Melanie already supported Miltenyi Biotec in her role as Application Development Specialist and Clinical Product Specialist for more than three years. During that time, she was responsible for technical support and application training on Miltenyi Biotec’s clinical product portfolio with focus on cell and gene therapy applications and related products.

Stefan Wild

Senior Manager, Research and Development, Miltenyi Biotec

Stefan Wild received his degree in chemistry at the Ludwig-Maximilians-University Munich, Germany in 1998. He completed his PhD in biochemistry in 2001. He was working as research scientist for Memorec Stoffel GmbH from 2002 to 2005. Since 2005 he is senior scientist R&D at Miltenyi Biotec. As a group leader, he is responsible for the application developments of the CliniMACS Electroporator.

Kunal Patel

Process Engineering Manager, Miltenyi Biotec

Kunal Patel is head of Process Engineering for Miltenyi Biotec’s CDMO site in San Jose, California. He is responsible for overseeing the Process Development activities for the scalable production of cellular therapeutics capable of supporting clinical trials and ultimate commercialization. Kunal has been with Miltenyi Biotec since 2017, and in the cellular therapy CDMO space for over 6 years. In this time Kunal has contributed to over a dozen programs from pre-clinical development to open INDs.

SPEAKERS

Melanie Rietenbach
Global Product Manager Miltenyi Biotec
Melanie Rietenbach
Global Product Manager Miltenyi Biotec
Melanie Rietenbach is Global Product Manager for the clinical engineered cellsportfolio including CAR T and CAR NK cells at Miltenyi Biotec. During the pastyear, she has been working together with the R&D and Clinical DevelopmentTeam in order to advance the development of tools to enable CAR T and CAR NKcell immunotherapy. Before that, Melanie already supported Miltenyi Biotec inher role as Application Development Specialist and Clinical Product Specialistfor more than three years. During that time, she was responsible for technicalsupport and application training on Miltenyi Biotec’s clinical productportfolio with focus on cell and genetherapy applications and related products.
Stefan Wild
Senior Manager, Research and Development, Miltenyi Biotec
Stefan Wild
Senior Manager, Research and Development, Miltenyi Biotec
Stefan Wild received his degree in chemistry at the Ludwig-Maximilians-University Munich, Germany in 1998. He completed his PhD in biochemistry in 2001. He was working as research scientist for Memorec Stoffel GmbH from 2002 to 2005. Since 2005 he is senior scientist R&D at Miltenyi Biotec. As a group leader, he is responsible for the application developments of the CliniMACS Electroporator.
Kunal Patel
Process Engineering Manager, Miltenyi Biotec
Kunal Patel
Process Engineering Manager, Miltenyi Biotec
Kunal Patel is head of Process Engineering for Miltenyi Biotec’s CDMO site in San Jose, California. He is responsible for overseeing the Process Development activities for the scalable production of cellular therapeutics capable of supporting clinical trials and ultimate commercialization. Kunal has been with Miltenyi Biotec since 2017, and in the cellular therapy CDMO space for over 6 years. In this time Kunal has contributed to over a dozen programs from pre-clinical development to open INDs.