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Ex vivo Manufactured Neutrophils for Treatment of Neutropenia-A Process Economic Evaluation.
Torres-Acosta, Mario A; Harrison, Richard P; Csaszar, Elizabeth; Rito-Palomares, Marco; Brunck, Marion E G.
Afiliação
  • Torres-Acosta MA; Centro de Biotecnología FEMSA, Tecnológico de Monterrey, Monterrey, Mexico.
  • Harrison RP; Centre for Biological Engineering, Holywell Park, Loughborough University, Loughborough, United Kingdom.
  • Csaszar E; Wolfson Centre for Stem Cells, Tissue Engineering and Modelling (STEM), School of Medicine, Nottingham, United Kingdom.
  • Rito-Palomares M; Centre for Commercialization of Regenerative Medicine, Toronto, ON, Canada.
  • Brunck MEG; Escuela de Medicina y Ciencias de la Salud, Tecnológico de Monterrey, Monterrey, Mexico.
Front Med (Lausanne) ; 6: 21, 2019.
Article em En | MEDLINE | ID: mdl-30881955
Neutropenia is a common side-effect of acute myeloid leukemia (AML) chemotherapy characterized by a critical drop in neutrophil blood concentration. Neutropenic patients are prone to infections, experience poorer clinical outcomes, and require expensive medical care. Although transfusions of donor neutrophils are a logical solution to neutropenia, this approach has not gained clinical traction, primarily due to challenges associated with obtaining sufficiently large numbers of neutrophils from donors whilst logistically managing their extremely short shelf-life. A protocol has been developed that produces clinical-scale quantities of neutrophils from hematopoietic stem and progenitor cells (HSPC) in 10 L single-use bioreactors (1). This strategy could be used to mass produce neutrophils and generate sufficient cell numbers to allow decisive clinical trials of neutrophil transfusion. We present a bioprocess model for neutrophil production at relevant clinical-scale. We evaluated two production scenarios, and the impact on cost of goods (COG) of multiple model parameters including cell yield, materials costs, and process duration. The most significant contributors to cost were consumables and raw materials, including the cost of procuring HSPC-containing umbilical cord blood. The model indicates that the most cost-efficient culture volume (batch size) is ~100 L in a single bioreactor. This study serves as a framework for decision-making and optimization strategies when contemplating the production of clinical quantities of cells for allogeneic therapy.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline / Health_economic_evaluation / Prognostic_studies Idioma: En Revista: Front Med (Lausanne) Ano de publicação: 2019 Tipo de documento: Article País de afiliação: México País de publicação: Suíça

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Tipo de estudo: Guideline / Health_economic_evaluation / Prognostic_studies Idioma: En Revista: Front Med (Lausanne) Ano de publicação: 2019 Tipo de documento: Article País de afiliação: México País de publicação: Suíça