Simplifying GMP CAR-T and CAR NK cell therapy manufacturing processes

Martha Luevano is responsible for the clinical Engineered cells portfolio including CAR-T and CAR NK cells at Miltenyi Biotec. During the past 5 years, she has been working together with R&D and the Clinical Development team in order to advance the development of tools to enable CAR-T and CAR NK cell immunotherapy.

Prior to joining Miltenyi Biotec, Martha did her postdoctoral research in stem cells (Miltenyi Biotec-Marie Curie fellowship) and her PhD in the Anthony Nolan (University College London) finding solutions to expand NK cells for therapeutic purposes. Her combined experience in molecular and cellular research has made her the recipient of international grants and fellowships.

Dr. Wang was trained by Dr. Adolfo García-Sastre and received her Ph.D. in Biomedical Sciences from the Mount Sinai School of Medicine in New York. She joined Dr. Peter Cresswell’s laboratory in the Department of Immunology at Yale University as a Howard Hughes Medical Institute fellow, and later as a Cancer Research Institute postdoctoral associate.

Dr. Wang joined Memorial Sloan Kettering Cancer Center in 2007, and is currently the Associate Director of the Michael G Harris Cell Therapy and Cell Engineering Facility, and an Associate Lab Member in the Department of Molecular Pharmacology. Dr. Wang is in charge of the R&D, process development and manufacturing.

She has overseen the successful manufacturing of all the CAR T cell products used in 13 phase I/II clinical trials, over 20 batches of cGMP grade viral vectors, as well as tech transfers to multiple industrial partners. She served in the translational science and product development committee in the American Society of Gene and Cell Therapy (ASGCT). She is currently a member for the National Heart, Lung and Blood Institute (NHLBI) independent external expert panel and a committee member for the Alliance of Regenerate Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).

Stephan Fricke began his medical studies at the University of Leipzig in 1999, which he successfully completed in 2005. He then began his specialist training and completed his doctorate at the University of Leipzig in 2007. Since 2006 he has been working as a research group leader at Fraunhofer IZI in Leipzig in addition to his clinical activities. Here he leads several research projects dealing with increasing the safety and efficiency of stem cell transplantation for leukemia and lymphoma, develops antibody-based therapies and CAR-ATMP strategies for stem cell transplantation with a focus on clinical applicability. During this time, he completed his training as a specialist in internal medicine and haematology and oncology, acquired the specialist immunologist from DGfI and completed his habilitation.

Since 2019 he is also head of the GMP process development unit at Fraunhofer IZI. This department realizes the transfer of manufacturing processes from the laboratory to a clinical scale. With the aim of obtaining official manufacturing authorizations for the production of clinical test samples, GMP-compliant processes are newly developed or existing processes are adapted and optimized. The focus is on cell- and gene-based drugs (Advanced Therapy Medicinal Products). These include antigen-specific T cells, CAR T cells and CAR NK cells. The development of GMP-compliant manufacturing protocols is closely accompanied by the definition of corresponding quality controls. In the development unit, process adaptations can be tested and optimized flexibly and cost-effectively.

Kate graduated from University College London with a PhD in Stem Cell Bioprocessing before undertaking a postdoctoral position at the Institute of Ophthalmology, UCL. Here, as part of The London Project team, she developed and transferred an embryonic stem cell-derived ATMP from research through to GMP clinical manufacture as part of a FTIH clinical trial.

She joined GSK’s CGT Product Development team in 2017, where she now works to deliver the CMC aspects of various T cell assets from early phase through to launch, and the development of innovative technologies to enable step-change improvements to CGT manufacture. Kate specializes in cell process development, seeking to optimize the manufacture of CGT-based treatments, using increased automation and leading-edge processing technology.