Cell therapy products are revolutionizing multiple therapeutic areas; to maintain this pace of innovation, manufacturing solutions must adapt

Abstract Although cell therapies continue to reshape multiple therapeutics areas, the field is still grappling with how to best manufacture therapies. Allogeneic therapies are currently manufactured at larger scale but additional effort is required to optimize starting material choice, final product shipping logistics, and whether incremental patient-specific cell modification is needed at the point-of-care. Autologous cell therapies are currently manufactured at commercial scale, but for smaller patient populations. This will change. As autologous cell therapy manufacturing expands, manufacturing platforms which are closed, automated, and scalable, will be vital. The migration to closed, automated, and scalable manufacturing platforms will provide an avenue to decrease therapeutic cost, while maintaining quality and increasing patient access. This is critical for the field’s continued evolution.

[1]  Asher Mullard FDA approves fourth CAR-T cell therapy , 2021, Nature Reviews Drug Discovery.

[2]  Z. Cui,et al.  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, Cytotherapy.

[3]  D. James How short-term gain can lead to long-term pain , 2017 .

[4]  S. Mailankody,et al.  Future of CAR T cells in multiple myeloma. , 2020, Hematology. American Society of Hematology. Education Program.

[5]  Matthew J. Frigault,et al.  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, The Lancet.

[6]  Xianjun Yu,et al.  Molecular alterations and targeted therapy in pancreatic ductal adenocarcinoma , 2020, Journal of Hematology & Oncology.

[7]  M. Kami,et al.  Difference between hematological malignancy and Solid tumor research articles published in four major medical journals , 2006, Leukemia.

[8]  Roddy S. O’Connor,et al.  In Like a Lamb; Out Like a Lion: Marching CAR T Cells Toward Enhanced Efficacy in B-ALL , 2021, Molecular Cancer Therapeutics.

[9]  Nicholas Medcalf Decentralized manufacture of cell therapies: the challenge of operational modeling , 2019 .

[10]  S. Gottschalk,et al.  Allogeneic CAR Cell Therapy—More Than a Pipe Dream , 2021, Frontiers in Immunology.

[11]  F. Rahbarizadeh,et al.  Strategies for having a more effective and less toxic CAR T-cell therapy for acute lymphoblastic leukemia , 2020, Medical Oncology.

[12]  Jahid Hasan,et al.  The necessity of automated manufacture for cell-based immunotherapies: a cost-based analysis , 2020, Cell and Gene Therapy Insights.

[13]  F. Barkalow,et al.  Cancer cell therapies: the clinical trial landscape , 2020, Nature reviews. Drug discovery.

[14]  V. Dutoit,et al.  Allogeneic CAR T Cells: An Alternative to Overcome Challenges of CAR T Cell Therapy in Glioblastoma , 2021, Frontiers in Immunology.

[15]  J. Marshall,et al.  Current Perspectives on the Use of off the Shelf CAR-T/NK Cells for the Treatment of Cancer , 2021, Cancers.

[16]  A. Schambach,et al.  Use of Cell and Genome Modification Technologies to Generate Improved “Off-the-Shelf” CAR T and CAR NK Cells , 2020, Frontiers in Immunology.

[17]  C. Mackall,et al.  The Emerging Landscape of Immune Cell Therapies , 2020, Cell.

[18]  R. Kolhe,et al.  Epidemiology, Staging, and Management of Multiple Myeloma , 2021, Medical sciences.

[19]  M. Juan,et al.  Adult peripheral blood and umbilical cord blood NK cells are good sources for effective CAR therapy against CD19 positive leukemic cells , 2019, Scientific Reports.

[20]  Christopher G. Ramsborg,et al.  Accelerating the development of innovative cellular therapy products for the treatment of cancer. , 2020, Cytotherapy.

[21]  J. Appelbaum,et al.  Hematopoietic Stem Cell Transplantation in the Era of Engineered Cell Therapy , 2018, Current Hematologic Malignancy Reports.