VueLife®

Monocytes/Dendritic Cells

o    Title: Development and validation of a fully GMP-compliant production process of autologous, tumor-lysate-pulsed dendritic cells

·   Products Used: 118-mL VueLife® Bags (For DC generation)

·   Formal Citation: Eyrich, M., Schreiber, S. C., Rachor, J., Krauss, J., Pauwels, F., Hain, J., … Van Gool, S. W. (2014). Development and validation of a fully GMP-compliant production process of autologous, tumor-lysate-pulsed dendritic cells. Cytotherapy, 16(7), 946–964. http://doi.org/10.1016/j.jcyt.2014.02.017

o    Title: A full scale comparative study of methods for generation of functional Dendritic cells for use as cancer vaccines

·   Products Used: VueLife® Bags (For DC generation)

·   Formal Citation: Jarnjak-Jankovic, S., Hammerstad, H., Saebøe-Larssen, S., Kvalheim, G., & Gaudernack, G. (2007). A full scale comparative study of methods for generation of functional Dendritic cells for use as cancer vaccines. BMC Cancer, 7, 119. http://doi.org/10.1186/1471-2407-7-119

o    Title: Clinical-Scale Generation of Dendritic Cells in a Closed System

·   Products Used: 118-mL VueLife® Bags (For DC generation)

·   Formal Citation: Sorg, R. V, Ozcan, Z., Brefort, T., Fischer, J., Ackermann, R., Müller, M., & Wernet, P. (2003). Clinical-scale generation of dendritic cells in a closed system. Journal of Immunotherapy (Hagerstown, Md. : 1997), 26(4), 374–383. http://doi.org/10.1097/00002371-200307000-00010

o    Title: In Vitro Production of Dendritic Cells from Human Blood Monocytes for Therapeutic Use

·   Products Used: 100-mL VueLife® Bags (For DC generation)

·   Formal Citation: Garderet, L., Cao, H., Salamero, J., Vergé, V., Tisserand, E., Scholl, S., … Lopez, M. (2001). In vitro production of dendritic cells from human blood monocytes for therapeutic use. Journal of Hematotherapy & Stem Cell Research, 10(4), 553–567. http://doi.org/10.1089/15258160152509163

o    Title: A functional comparison of mature human dendritic cells prepared in fluorinated ethylene-propylene bags or polystyrene flask

·   Products Used:  VueLife® Bags (For DC generation)

·   Formal Citation: Kurlander, R. J., Tawab, A., Fan, Y., Carter, C. S., & Read, E. J. (2006). A functional comparison of mature human dendritic cells prepared in fluorinated ethylene-propylene bags or polystyrene flasks. Transfusion, 46(9), 1494–1504. http://doi.org/10.1111/j.1537-2995.2006.00940.x

o    Title: Closing the manufacturing process of dendritic cell vaccines transduced with adenovirus vectors

·   Products Used: 225-mL VueLife® Bags (For DC generation) and 72-mL VueLife® bags (For concentration/wash)

·   Formal Citation: Gulen, D., Abe, F., Maas, S., Reed, E., Cowan, K., Pirruccello, S., … Talmadge, J. E. (2008). Closing the manufacturing process of dendritic cell vaccines transduced with adenovirus vectors. International Immunopharmacology, 8(13–14), 1728–1736. http://doi.org/10.1016/j.intimp.2008.08.010

o    Title: A Protocol for Generation of Clinical Grade mRNA- Transfected Monocyte-Derived Dendritic Cells for Cancer Vaccines

·   Products Used: VueLife® Bags (For DC generation)

·   Formal Citation: Mu, L. J., Gaudernack, G., Sæbøe-Larssen, S., Hammerstad, H., Tierens, a., & Kvalheim, G. (2003). A Protocol for Generation of Clinical Grade mRNA-Transfected Monocyte-Derived Dendritic Cells for Cancer Vaccines. Scandinavian Journal of Immunology, 58(5), 578–586. http://doi.org/10.1046/j.1365-3083.2003.01333.x

o    Title: Ex vivo expansion of tumor specific lymphocytes with IL-15 and IL-21 for adoptive immunotherapy in melanoma

·   Products Used:  75-mL VueLife® Bags (For DC generation)

·   Formal Citation: Huarte, E., Fisher, J., Turk, M. J., Mellinger, D., Foster, C., Wolf, B., … Ernstoff, M. S. (2009). Ex vivo expansion of tumor specific lymphocytes with IL-15 and IL-21 for adoptive immunotherapy in melanoma. Cancer Letters, 285(1), 80–88. http://doi.org/10.1016/j.canlet.2009.05.003

T Cells

o    Title: Manufacturing of Large Numbers of Patient-specific T Cells for Adoptive Immunotherapy

·   Products Used: VueLife® Bags (For initial T-cell expansion)

·   Formal Citation: Tran, C.-A., Burton, L., Russom, D., Wagner, J. R., Jensen, M. C., Forman, S. J., & DiGiusto, D. L. (2007). Manufacturing of Large Numbers of Patient-specific T Cells for Adoptive Immunotherapy. Journal of Immunotherapy, 30(6), 644–654. http://doi.org/10.1097/CJI.0b013e318052e1f4

o    Title: Ex Vivo Expansion and Th1/Tc1 Maturation of Umbilical Cord Blood T Cells by CD3/CD28 Costimulation

·   Products Used: VueLife® Bags (For T-cell expansion)

·   Formal Citation: Mazur, M. A., Davis, C. C., & Szabolcs, P. (2008). Ex Vivo Expansion and Th1/Tc1 Maturation of Umbilical Cord Blood T Cells by CD3/CD28 Costimulation. Biology of Blood and Marrow Transplantation, 14(10), 1190–1196. http://doi.org/10.1016/j.bbmt.2008.07.016

o    Title: Phenotypic and Functional Attributes of Lentivirus-modified CD19-specific Human CD8+ Central Memory T Cells Manufactured at Clinical Scale

·   Products Used: 32-mL VueLife® AC Bags (For spinoculation and initial T-cell expansion), 730-mL VueLife® Bags (For T-cell expansion)

·   Formal Citation: Wang, X., Naranjo, A., Brown, C. E., Bautista, C., Wong, C. W., Chang, W.-C., … Jensen, M. C. (2013). Phenotypic and functional attributes of lentivirus-modified CD19-specific human CD8+ central memory T cells manufactured at clinical scale. Journal of Immunotherapy (Hagerstown, Md. : 1997), 35(9), 689–701. http://doi.org/10.1097/CJI.0b013e318270dec7

NK Cells

o    Title: Generation and qualification of a GMP compliant master cell stock of CAR expressing ErbB2-specific NK-92 cells for clinical trials

·   Products Used: VueLife® Bags (For NK cell expansion)

·   Formal Citation: Nowakowska, P., Odendahl, M., Schönfeld, K., Zhang, C., Bönig, H., Grez, M., … Tonn, T. (2014). Generation and qualification of a GMP compliant master cell stock of CAR expressing ErbB2-specific NK-92 cells for clinical trials. Transfusion Medicine and Hemotherapy, 41, 98. http://dx.doi.org/10.1016/j.jcyt.2014.01.089

o    Title: NK-92 therapy is well tolerated, has minimal toxicity and shows efficacy in a phase I trial of patients with relapsed/refractory hematological malignancies relapsing after autologous stem cell transplantation

·   Products Used: VueLife® Bags (For NK cell expansion)

·   Formal Citation: Williams, B., Routy, B., Den Hollander, N., Wang, X. H., Chaboureau, A., Viswanathan, S., & Keating, A. (2015). NK-92 therapy is well tolerated, has minimal toxicity and shows efficacy in a phase I trial of patients with relapsed/refractory hematological malignancies relapsing after autologous stem cell transplantation. BLOOD, 126(23), 4297. Retrieved from http://www.embase.com/search/results?subaction=viewrecord&from=export&id=L72174987%5Cnhttp://www.bloodjournal.org/content/126/23/4297

o    Title: Clinical-grade, large-scale, feeder-free expansion of highly active human natural killer cells for adoptive immunotherapy using an automated bioreactor

·   Product Used: 72-mL VueLife® Bags (For NK expansion)

·   Formal Citation: Sutlu, T., Stellan, B., Gilljam, M., Quezada, H. C., Nahi, H., Gahrton, G., & Alici, E. (2010). Clinical-grade, large-scale, feeder-free expansion of highly active human natural killer cells for adoptive immunotherapy using an automated bioreactor. Cytotherapy, 12(8), 1044–1055. http://doi.org/10.3109/14653249.2010.504770