title: Towards a commercial process for the manufacture of genetically modified T cells for therapy.
abstract: The recent successes of adoptive T-cell immunotherapy for the treatment of hematologic malignancies have highlighted the need for manufacturing processes that are robust and scalable for product commercialization. Here we review some of the more outstanding issues surrounding commercial scale manufacturing of personalized-adoptive T-cell medicinal products. These include closed system operations, improving process robustness and simplifying work flows, reducing labor intensity by implementing process automation, scalability and cost, as well as appropriate testing and tracking of products, all while maintaining strict adherence to Current Good Manufacturing Practices and regulatory guidelines. A decentralized manufacturing model is proposed, where in the future patients' cells could be processed at the point-of-care in the hospital.
authors.affiliation: Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.
authors.forename: A D
authors.initials: AD
authors.lastname: Kaiser
authors.affiliation: Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Assenmacher
authors.affiliation: Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Schröder
authors.affiliation: Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Meyer
authors.affiliation: Lentigen Technology Inc., Gaithersburg, MD, USA.
authors.forename: R
authors.initials: R
authors.lastname: Orentas
authors.affiliation: Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Bethke
authors.affiliation: Lentigen Technology Inc., Gaithersburg, MD, USA.
authors.forename: B
authors.initials: B
authors.lastname: Dropulic
mesh_terms: D019070:Cell Lineage / Q000235:genetics / Q000276:immunology; D064987:Cell- and Tissue-Based Therapy; D005818:Genetic Engineering; D019337:Hematologic Neoplasms / Q000276:immunology / Q000628:therapy*; D006801:Humans; D016219:Immunotherapy, Adoptive; D008213:Lymphocyte Activation / Q000276:immunology; D011948:Receptors, Antigen, T-Cell / Q000276:immunology / Q000627:therapeutic use; D013601:T-Lymphocytes / Q000276:immunology* / Q000637:transplantation; D014481:United States
chemical_list: D011948:Receptors, Antigen, T-Cell