Abstract
Background aims: The final harvest or wash of a cell therapy product is an important step in manufacturing, as viable cell recovery is critical to the overall success of a cell therapy. Most harvest/wash approaches in the clinical lab involve centrifugation, which can lead to loss of cells and decreased viability of the final product. Here the authors report on a multi-center assessment of the LOVO Cell Processing System (Fresenius Kabi, Bad Homburg, Germany), a cell processing device that uses a spinning filtration membrane instead of centrifugation. Methods: Four National Institutes of Health Production Assistance for Cellular Therapies cell processing facilities (CPFs) assessed the LOVO Cell Processing System for final harvest and/or wash of the following three different cell products: activated T cells (ATCs), tumor-infiltrating lymphocytes (TILs) and bone marrow-derived mesenchymal stromal cells (MSCs). Each site compared their current in-house, routinely used method of final cell harvest and/or wash with that of the LOVO device. Results: Final harvest and/or wash of ATCs, TILs and MSCs using the LOVO system resulted in satisfactory cell viability and recovery with some substantial improvement over the in-house methods of CPFs. Processing time was variable among cell types/facilities. Conclusions: The LOVO Cell Processing System provides an alternative to centrifuge-based technologies. The system employs a spinning membrane filter, exposing cells to minimal g-forces compared with centrifugation, and is automated and closed. This small multi-center study demonstrated the ability of the LOVO device to yield satisfactory cell viability and recovery of T cells and MSCs.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 691-698 |
| Number of pages | 8 |
| Journal | Cytotherapy |
| Volume | 24 |
| Issue number | 7 |
| DOIs | |
| State | Published - Jul 2022 |
Bibliographical note
Funding Information:This study was supported by the PACT program sponsored by the National Institutes of Health (National Heart, Lung, and Blood Institute) and included contracts for the following centers: Center for Cell and Gene Therapy , Baylor College of Medicine (AG, principal investigator [PI]; HHSN268201600015I ); Center for Biomedicine and Genetics , City of Hope (JG, PI; HHSN268201600011I ); Interdisciplinary Stem Cell Institute Cellular Manufacturing Program , Miller School of Medicine, University of Miami (JH, PI; HHSN268201600012I ); Molecular and Cellular Therapeutics, University of Minnesota (DHM, PI; HHSN268201600014I ); Moffitt Cancer Center (LK, PI; HHSN268201600013I ); and PACT Coordinating Center, The Emmes Company , LLC (RA, PI; HHSN268201600020C ).
Funding Information:
This study was supported by the PACT program sponsored by the National Institutes of Health (National Heart, Lung, and Blood Institute) and included contracts for the following centers: Center for Cell and Gene Therapy, Baylor College of Medicine (AG, principal investigator [PI]; HHSN268201600015I); Center for Biomedicine and Genetics, City of Hope (JG, PI; HHSN268201600011I); Interdisciplinary Stem Cell Institute Cellular Manufacturing Program, Miller School of Medicine, University of Miami (JH, PI; HHSN268201600012I); Molecular and Cellular Therapeutics, University of Minnesota (DHM, PI; HHSN268201600014I); Moffitt Cancer Center (LK, PI; HHSN268201600013I); and PACT Coordinating Center, The Emmes Company, LLC (RA, PI; HHSN268201600020C). Conception and design of the study: LA, DHM. Acquisition of data: MG, CC, AO, IU, AO, DS(5) Analysis and interpretation of data: LI, RA, AG, AB, LK, AK, NL, DS (1), DHM. Drafting or revising the manuscript: LI, RA, AG, JMH, AK, AB, LK, NL, DS (1), DHM. All authors have approved the final article.
Funding Information:
This study was performed under the National Institutes of Health (National Heart, Lung, and Blood Institute)-sponsored Production Assistance for Cellular Therapies (PACT) contract mechanism. Four PACT manufacturing centers participated in the study: Center for Cell and Gene Therapy, Baylor College of Medicine (Houston, TX, USA); Interdisciplinary Stem Cell Institute Cellular Manufacturing Program, University of Miami (Miami, FL, USA); Molecular and Cellular Therapeutics, University of Minnesota (Saint Paul, MN, USA); and Moffitt Cancer Center (Tampa, FL, USA). The PACT Coordinating Center, The Emmes Company, LLC (Rockville, MD, USA), oversaw data collection and analysis. Each site chose a cell type to assess and compared their current in-house, routinely used method of final cell harvest and/or wash with that of the LOVO system. Baylor College of Medicine and Moffitt Cancer Center evaluated the LOVO device for harvest and wash of activated T cells (ATCs) and tumor-infiltrating lymphocytes (TILs), respectively. The University of Minnesota and University of Miami both assessed the LOVO device with bone marrow-derived mesenchymal stromal cells (MSCs), with the University of Minnesota looking at large-volume harvest and the University of Miami looking at post-thaw dimethyl sulfoxide (DMSO) removal. The focus of the study was on processing time and cell viability and recovery. Two centers looked at additional testing, including residual cytokine levels (Baylor College of Medicine) and post-thaw short-term stability and cytokine expression (University of Miami).
Publisher Copyright:
© 2022 International Society for Cell & Gene Therapy
Keywords
- Cell Culture
- Harvest
- Mesenchymal Stromal Cells
- Recovery
- T Cells
- Viability
PubMed: MeSH publication types
- Journal Article
- Multicenter Study
- Research Support, N.I.H., Extramural
