![]() Developed in partnership with Guangzhou Institutes of Biomedicine & Health, our 3 rd generation 1928T2z CAR construct consists of a murine anti-CD19 scFv (FMC63) with CD28 and CD3z signaling domains, alongside a novel TLR2-derived costimulatory domain. The toll-like receptor (TLR) and MyD88 signalling pathway is emerging as a promising new avenue for chimeric antigen receptor (CAR) co-stimulation 1. #Texmacs gmp medium trialMalaghan Institute of Medical Research CAR T-cell Research Programme,Īn overview of the Malaghan Institute of Medical Research’s experience of launching a phase 1 trial of a autologous third generation CAR T-cell therapy incorporating a novel TLR2 costimulatory domain, and our early experience of an automated CAR T-cell manufacturing protocol using the Lonza Cocoon ®. Senior Cancer Research Fellow and Team Leader After aseptic process validation, several different products can be produced in one clean room at a time. During the presentation a summary of key facts to show integrity of the tubing sets and therefore sterility of the final product is shown. In combination with the other components of the CliniMACS Prodigy System, it allows to perform all manufacturing steps in a single, automated and functionally closed system. ![]() An essential part of the CliniMACS Prodigy System is the CliniMACS Prodigy Tubing Set, a sterile, single-use disposable which is tested on biocompatibility. The CliniMACS Prodigy System is the state of the art manufacturing platform for cell therapy products. To enable scalable GMP-compliant manufacturing on a single device and within a single process setup, fully closed and disposable tubing sets keep cells safe (sterility/cross contamination) from starting material to final cell product. Fully automated cell processing for innovative and complex cell manufacturing protocols has become a reality. #Texmacs gmp medium how toFor innovators surveying how to transform their processes from early development to large-scale cell manufacturing, automation is key. Global Head of Regulatory Affairs, Miltenyi BiotecĪs the cell and gene therapy field gains importance, the demands for flexibility, reliability, scalability, and value have radically increased. It also provides a platform for the manufacture of novel CAR T-cell products for use in clinical trials.įollowing successful completion of the validation studies, a Phase 1 clinical trial of POC manufactured CD19 CAR T-cells is now open to patients with relapsed or refractory CD19+ haematological malignancy who are ineligible for government-funded commercial CAR T-cells. POC manufacture of CAR T-cells enables the infusion of fresh rather than cryopreserved CAR T-cells with reduced turnaround time for production (12 days) and decreased cost (anticipated 40 – 80% reduction in cost per product compared to current commercial products). Preliminary stability studies were performed on the formulated, and cryopreserved CD19 CAR T-cell products. All CAR19 T-cell products met specification for viability, transduction efficiency, absence of microbial contamination during in-process sampling, and in the final formulated product, mycoplasma and endotoxin, and qPCR testing for replication competent lentivirus (RCL) and lentiviral copy number. The three POC validation procedures resulted in CD19 CAR T-cell products with adequate viable CAR T-cell doses. Quality assurance testing was performed on starting material MNC(A), CD4+/CD8+ selected MNC(A), day 5, day 9 and day 12 (formulated CD19 CAR T-cell product). Transduction with lentiviral vector was scheduled 24h post T cell activation, followed by T cell expansion in TexMACS GMP medium supplemented with IL7 and IL15 for 11 days. Following selection, 1 x 10^8 CD3+ T-cells were activated using TransAct®. Mononuclear cells (MNC(A)) were collected from healthy donors by apheresis and a maximum of 20 x 10^9 WCC or 3 x 10^9 CD3+ T-cells were loaded onto the device for immunomagenetic selection of CD4+ and CD8+ T cells. ![]() Three validation procedures were performed for the in-house production of CD19 CAR T-cells using the T-cell Transduction (TCT) program on the Prodigy®. The Cellular Therapy Program at the Royal Brisbane and Women’s Hospital, in collaboration with QIMR Berghofer, has developed Point-of-Care manufacturing of CAR T-cells using the Miltenyi Biotec CliniMACS Prodigy® and a lentiviral vector (Lentigen, Miltenyi Biotec) to expand the availability of CAR T- cells to patients who are ineligible for government funded commercial CAR T-cells. ![]() QIMR Berghofer Medical Research Institute 2 Hutchins CJ 1, Henderson AJ 1, Henden AS 1,2, Abaca-Cleopas ME 1, Acworth M 1, Lynam E 1, Barnes EC 1, McEnroe B 2, McLean A 1, Mudie K 1, Kennedy GA 1 and Tey SK 1,2Ĭellular Therapy Laboratory, Cancer Care Services, Royal Brisbane & Women’s Hospital 1
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