Expanding access to CAR T cell therapies through local manufacturing

Allogeneic BCMA-targeting CAR T cells in relapsed/refractory multiple myeloma: phase 1 UNIVERSAL trial interim results

(2023) Sham Mailankody et al.   NATURE MEDICINE

Base-Edited CAR7 T Cells for Relapsed T-Cell Acute Lymphoblastic Leukemia

(2023) Robert Chiesa et al.   NEW ENGLAND JOURNAL OF MEDICINE

“Waitlist mortality” is high for myeloma patients with limited access to BCMA therapy

(2023) Nausheen Ahmed et al.   Frontiers in Oncology

The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001

(2022) Esteve Trias et al.   BONE MARROW TRANSPLANTATION

Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products

(2022) Natividad Cuende et al.   CYTOTHERAPY

Engineered cellular immunotherapies in cancer and beyond

(2022) Amanda V. Finck et al.   NATURE MEDICINE

Molecular signatures of antitumor neoantigen-reactive T cells from metastatic human cancers

(2022) Frank J. Lowery et al.   SCIENCE

GMP-Compliant Manufacturing of TRUCKs: CAR T Cells targeting GD2 and Releasing Inducible IL-18

(2022) Wolfgang Glienke et al.   Frontiers in Immunology

Ethical challenges with CAR T slot allocation with idecabtagene vicleucel manufacturing access.

(2022) Taxiarchis Kourelis et al.   JOURNAL OF CLINICAL ONCOLOGY

Toward Rapid, Widely Available Autologous CAR-T Cell Therapy – Artificial Intelligence and Automation Enabling the Smart Manufacturing Hospital

(2022) Simon Hort et al.   Frontiers in Medicine

Phase 1 clinical trial of CRISPR-engineered CAR19 universal T cells for treatment of children with refractory B cell leukemia

(2022) Giorgio Ottaviano et al.   Science Translational Medicine

Potential solutions for manufacture of CAR T cells in cancer immunotherapy

(2022) Ulrich Blache et al.   Nature Communications

UCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial

(2022) Reuben Benjamin et al.   Lancet Haematology

Automated, scaled, transposon-based production of CAR T cells

(2022) Dominik Lock et al.   Journal for ImmunoTherapy of Cancer

Geographic and Racial Disparities in Access to Chimeric Antigen Receptor–T Cells and Bispecific Antibodies Trials for Multiple Myeloma

(2022) Raghad Alqazaqi et al.   JAMA Network Open

Real-World Impact of Time from Leukapheresis to Infusion (Vein-to-Vein Time) in Patients with Relapsed or Refractory (r/r) Large B-Cell Lymphoma (LBCL) Treated with Axicabtagene Ciloleucel

(2022) Frederick L. Locke et al.   BLOOD

Decentralized manufacturing of anti CD19 CAR-T cells using CliniMACS Prodigy®: real-world experience and cost analysis in India

(2022) Hamenth Kumar Palani et al.   BONE MARROW TRANSPLANTATION

Clinical outcome of patients with relapsed refractory multiple myeloma listed for BCMA directed commercial CAR-T therapy

(2022) Samer Al Hadidi et al.   BONE MARROW TRANSPLANTATION

Tumor-Infiltrating Lymphocyte Therapy or Ipilimumab in Advanced Melanoma

(2022) Maartje W. Rohaan et al.   NEW ENGLAND JOURNAL OF MEDICINE

Comparison between centralized and decentralized supply chains of autologous chimeric antigen receptor T-cell therapies: a UK case study based on discrete event simulation

(2021) Ching Lam et al.   CYTOTHERAPY

A nonviral, nonintegrating DNA nanovector platform for the safe, rapid, and persistent manufacture of recombinant T cells

(2021) Matthias Bozza et al.   Science Advances

Out of Specification Tisagenlecleucel Does Not Compromise Safety or Efficacy in Pediatric Acute Lymphoblastic Leukemia

(2021) Jenna Rossoff et al.   BLOOD

Manufacturing chimeric antigen receptor T cells from cryopreserved peripheral blood cells: time for a collect-and-freeze model?

(2021) Katie Palen et al.   CYTOTHERAPY

Multiple site place-of-care manufactured anti-CD19 CAR-T cells induce high remission rates in B-cell malignancy patients

(2021) Michael Maschan et al.   Nature Communications

Regulatory hurdles for CAR T-cell therapy in Japan

(2021) Sumimasa Nagai   Lancet Haematology

An industry survey of implementation strategies for clinical supply chain management of cell and gene therapies

(2021) Lequina Myles et al.   CYTOTHERAPY

Accelerating clinical-scale production of BCMA CAR T cells with defined maturation stages

(2021) Jara J. Joedicke et al.   Molecular Therapy-Methods & Clinical Development

Use of CAR-Transduced Natural Killer Cells in CD19-Positive Lymphoid Tumors

(2020) Enli Liu et al.   NEW ENGLAND JOURNAL OF MEDICINE

First-in-human data of ALLO-501 and ALLO-647 in relapsed/refractory large B-cell or follicular lymphoma (R/R LBCL/FL): ALPHA study.

(2020) Sattva Swarup Neelapu et al.   JOURNAL OF CLINICAL ONCOLOGY

Point-Of-Care CAR T-Cell Production (ARI-0001) Using a Closed Semi-automatic Bioreactor: Experience From an Academic Phase I Clinical Trial

(2020) Maria Castella et al.   Frontiers in Immunology

Advanced therapy medicinal product manufacturing under the hospital exemption and other exemption pathways in seven European Union countries

(2020) Delphi G.M. Coppens et al.   CYTOTHERAPY

Cost of decentralized CAR T‐cell production in an academic nonprofit setting

(2020) Tao Ran et al.   INTERNATIONAL JOURNAL OF CANCER

Next-Generation Manufacturing Protocols Enriching TSCM CAR T Cells Can Overcome Disease-Specific T Cell Defects in Cancer Patients

(2020) Silvia Arcangeli et al.   Frontiers in Immunology

Automated Manufacture of Autologous CD19 CAR-T Cells for Treatment of Non-hodgkin Lymphoma

(2020) Zachary Jackson et al.   Frontiers in Immunology

Classification of T-cell activation via autofluorescence lifetime imaging

(2020) Alex J. Walsh et al.   Nature Biomedical Engineering

Challenges and advantages of cell therapy manufacturing under Good Manufacturing Practices within the hospital setting

(2020) Emanuela M Iancu et al.   CURRENT OPINION IN BIOTECHNOLOGY

Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study

(2020) Jeremy S Abramson et al.   LANCET

CART19-BE-01: A Multicenter Trial of ARI-0001 Cell Therapy in Patients with CD19+ Relapsed/Refractory Malignancies

(2020) Valentín Ortíz-Maldonado et al.   MOLECULAR THERAPY

Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial

(2020) Nirav N. Shah et al.   NATURE MEDICINE

Genome-edited, donor-derived allogeneic anti-CD19 chimeric antigen receptor T cells in paediatric and adult B-cell acute lymphoblastic leukaemia: results of two phase 1 studies

(2020) Reuben Benjamin et al.   LANCET

Manufacturing and preclinical validation of CAR T cells targeting ICAM-1 for advanced thyroid cancer therapy

(2019) Yogindra Vedvyas et al.   Scientific Reports

CAR T cell viability release testing and clinical outcomes: is there a lower limit?

(2019) Elise A. Chong et al.   BLOOD

A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies

(2019) KAN WANG et al.   CYTOTHERAPY

GMP-Compliant Manufacturing of NKG2D CAR Memory T Cells Using CliniMACS Prodigy

(2019) Lucía Fernández et al.   Frontiers in Immunology

Decentralised manufacturing of cell and gene therapy products: Learning from other healthcare sectors

(2018) Richard P. Harrison et al.   BIOTECHNOLOGY ADVANCES

Induction of a central memory and stem cell memory phenotype in functionally active CD4+ and CD8+ CAR T cells produced in an automated good manufacturing practice system for the treatment of CD19+ acute lymphoblastic leukemia

(2018) Franziska Blaeschke et al.   CANCER IMMUNOLOGY IMMUNOTHERAPY

Closed-system manufacturing of CD19 and dual-targeted CD20/19 chimeric antigen receptor T cells using the CliniMACS Prodigy device at an academic medical center

(2018) Fenlu Zhu et al.   CYTOTHERAPY

Balancing Safety and Innovation for Cell-Based Regenerative Medicine

(2018) Peter Marks et al.   NEW ENGLAND JOURNAL OF MEDICINE

CAR T cell immunotherapy for human cancer

(2018) Carl H. June et al.   SCIENCE

Reducing Ex Vivo Culture Improves the Anti-leukemic Activity of Chimeric Antigen Receptor (CAR)-T Cells

(2018) Saba Ghassemi et al.   Cancer Immunology Research

Tisagenlecleucel in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma

(2018) Stephen J. Schuster et al.   NEW ENGLAND JOURNAL OF MEDICINE

Two-Dimensional Label-Free Affinity Analysis of Tumor-Specific CD8 T Cells with a Biomimetic Plasmonic Sensor

(2018) Maria Soler et al.   ACS Sensors

Development of a Novel Anti-CD19 Chimeric Antigen Receptor: A Paradigm for an Affordable CAR T Cell Production at Academic Institutions

(2018) Maria Castella et al.   Molecular Therapy-Methods & Clinical Development

Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma

(2017) Sattva S. Neelapu et al.   NEW ENGLAND JOURNAL OF MEDICINE

Label-free optical biosensor for on-line monitoring the integrated response of human B cells upon the engagement of stimulatory and inhibitory immune receptors

(2017) Istvan Kurucz et al.   SENSORS AND ACTUATORS B-CHEMICAL

Global Manufacturing of CAR T Cell Therapy

(2017) Bruce L. Levine et al.   Molecular Therapy-Methods & Clinical Development

The why, what, and how of the new FACT standards for immune effector cells

(2017) Marcela V. Maus et al.   Journal for ImmunoTherapy of Cancer

Automated manufacturing of chimeric antigen receptor T cells for adoptive immunotherapy using CliniMACS Prodigy

(2016) Ulrike Mock et al.   CYTOTHERAPY

Redefining the role of blood establishments as raw material suppliers, manufacturers, and distributors for new cell therapies: the Blood Systems experience

(2016) Frank Nizzi   TRANSFUSION

Multiplexed Nanoplasmonic Temporal Profiling of T-Cell Response under Immunomodulatory Agent Exposure

(2016) Bo-Ram Oh et al.   ACS Sensors

Future Supply Chains Enabled by Continuous Processing—Opportunities Challenges May 20–21 2014 Continuous Manufacturing Symposium

(2015) Jagjit Singh Srai et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

The puzzling situation of hospital exemption for advanced therapy medicinal products in Europe and stakeholders' concerns

(2014) Natividad Cuende et al.   CYTOTHERAPY

Quantitative Imaging of Protein Secretions from Single Cells in Real Time

(2013) Marc P. Raphael et al.   BIOPHYSICAL JOURNAL

T Cells with Chimeric Antigen Receptors Have Potent Antitumor Effects and Can Establish Memory in Patients with Advanced Leukemia

(2011) M. Kalos et al.   Science Translational Medicine