GMP production and testing of Xcellerated T Cells™ for the treatment of patients with CLL

Hami, Lisa; Green, C.; Leshinsky, Natasha; Markham, Eleanor; Miller, Kimberly P.; Craig, Stewart R

doi:10.1080/14653240410005348

Cited by 61 publications

(32 citation statements)

References 20 publications

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“…This has been driven primarily by their ease of use and elimination of resource-intensive cleaning and sterilization procedures needed for more traditional glass or stainless steel vessels. Several groups have reported successful use of such disposable technologies for preparation of clinical materials under GMP conditions (Hami et al, 2004), for production of monoclonal antibodies (Ling et al, 2003) and cryostorage (Ninomiya et al, 1991). These disposable vessels typically consist of hydrophobic polymer films such as polyethylene (PE) and ethyl vinyl acetate (EVA).…”

Section: Introductionmentioning

confidence: 99%

Quantitation of interaction of lipids with polymer surfaces in cell culture

Altaras

Eklund

Ranucci

et al. 2006

Biotech & Bioengineering

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As cell culture medium development efforts have progressed towards leaner, serum-free, and chemically defined formulations, it has become increasingly important to ensure that the appropriate concentrations of all nutrients are maintained and delivered at point of use. In light of concurrent efforts to progress to disposable polymeric storage and culture platforms, the characterization and control of medium component interactions with container surfaces can be a key issue in ensuring consistent delivery of these medium formulations. These studies characterize the interactions of lipids with culture surfaces typically encountered in the bioprocess industry using model systems. The extent and kinetics of lipid association with polymeric surfaces were determined using radio-labeled linoleic acid and cholesterol. The effect of methyl-beta-cyclodextrin, a component commonly used to solubilize lipids in culture media, on association kinetics was also examined. In addition, loss of lipids across a sterilizing membrane filter was quantified. We find that there is potential for significant loss of hydrophobic components due to non-specific binding to surfaces at timescales relevant to a typical cell culture process. The extent of loss is dependent on the nature of the hydrophobic component as well as the type of surface. These studies highlight the potential of the extracellular environment to modify medium composition and also emphasize the importance of medium formulation strategies, including those used in the delivery of hydrophobic components. It is noted, however, that the level of loss is very dependent on the specific system including the composition of the culture medium used.

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Section: Introductionmentioning

confidence: 99%

Quantitation of interaction of lipids with polymer surfaces in cell culture

Altaras

Eklund

Ranucci

et al. 2006

Biotech & Bioengineering

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“…Cells were thawed and cocultured with Dynal paramagnetic M-450 beads (Dynal Invitrogen) coated with anti-CD3 (OKT3; Ortho Biotech)/anti-CD28 (clone 9.3) at a ratio of 3 beads per cell first in a Baxter Lifecell flask and subsequently in the WAVE bioreactor system (GE Healthcare Biosciences). 40 Additional details of T-cell expansion and harvesting are described elsewhere 35 and in supplemental Methods (available on the Blood Web site; see the Supplemental Materials link at the top of the online article). The harvested cells were transported by courier from the cell production facility to the patient and infused on the same day (day 2 of transplantation).…”

Section: T-cell Expansion and Adoptive Transfermentioning

confidence: 99%

Combination immunotherapy using adoptive T-cell transfer and tumor antigen vaccination on the basis of hTERT and survivin after ASCT for myeloma

Rapoport

Aqui

Stadtmauer

et al. 2011

Blood

142

101

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“…Using this method, Levine and others have demonstrated up to 10 000-fold expansion of T cells from HIV + patients with recovery of a diverse TCR Vβ repertoire and functional competence (cytokine secretion) [95][96][97]. Similarly, CD3/ CD28 bead expansion of T cells has been utilized to propagate autologous T-cell populations for treating CLL, with a concomitant 400-fold depletion of malignant B cells during cultivation in a disposable 20-liter bioreactor [4]. Ex vivo-expanded T cells have also been used for donor leukocyte infusions (DLI) in conjunction with allogeneic HSCT for hematologic malignancies.…”

Section: Methods To Propagate T Cellsmentioning

confidence: 99%

Preparing clinical grade Ag-specific T cells for adoptive immunotherapy trials

DiGiusto

Cooper

2007

Cytotherapy

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The production of clinical-grade T cells for adoptive immunotherapy has evolved from the ex vivo numerical expansion of tumor-infiltrating lymphocytes to sophisticated bioengineering processes often requiring cell selection, genetic modification and other extensive tissue culture manipulations, to produce desired cells with improved therapeutic potential. Advancements in understanding the biology of lymphocyte signaling, activation, homing and sustained in vivo proliferative potential have redefined the strategies used to produce T cells suitable for clinical investigation. When combined with new technical methods in cell processing and culturing, the therapeutic potential of T cells manufactured in academic centers has improved dramatically. Paralleling these technical achievements in cell manufacturing is the development of broadly applied regulatory standards that define the requirements for the clinical implementation of cell products with ever-increasing complexity. In concert with academic facilities operating in compliance with current good manufacturing practice, the prescribing physician can now infuse T cells with a highly selected or endowed phenotype that has been uniformly manufactured according to standard operating procedures and that meets federal guidelines for quality of investigational cell products. In this review we address salient issues related to the technical, immunologic, practical and regulatory aspects of manufacturing these advanced T-cell products for clinical use.

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GMP production and testing of Xcellerated T Cells™ for the treatment of patients with CLL

Cited by 61 publications

References 20 publications

Quantitation of interaction of lipids with polymer surfaces in cell culture

Quantitation of interaction of lipids with polymer surfaces in cell culture

Combination immunotherapy using adoptive T-cell transfer and tumor antigen vaccination on the basis of hTERT and survivin after ASCT for myeloma

Preparing clinical grade Ag-specific T cells for adoptive immunotherapy trials

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