Shipping of therapeutic somatic cell products

Theresa L. Whiteside; Deborah L. Griffin; Joanna Stanson; William Gooding; David H McKenna; Darin Sumstad; Diane M Kadidlo; Adrian Gee; April Durett; Robert Lindblad; Deborah Wood; David Styers

doi:10.3109/14653249.2010.506507

Shipping of therapeutic somatic cell products

Theresa L. Whiteside, Deborah L. Griffin, Joanna Stanson, William Gooding, David H McKenna, Darin Sumstad, Diane M Kadidlo, Adrian Gee, April Durett, Robert Lindblad, Deborah Wood, David Styers

Research output: Contribution to journal › Article › peer-review

21 Scopus citations

Abstract

Background aims. Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products. Methods. Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility. Results. No consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight. Conclusions. This validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.

Original language	English (US)
Pages (from-to)	201-213
Number of pages	13
Journal	Cytotherapy
Volume	13
Issue number	2
DOIs	https://doi.org/10.3109/14653249.2010.506507
State	Published - Feb 2011

Bibliographical note

Funding Information:
This work was supported in part by PACT (NHLBI contract numbers N01-HB-37163, N01-HB-37164, N01-HB-37165 and N01-HB-37166 ). The authors would like to thank the staff at Baylor College of Medicine, University of Minnesota and the University of Pittsburgh for sample collection, shipping and testing. In addition, we would like to thank the EMMES Corporation for their assistance and dedication in bringing this manuscript to fruition.

Keywords

Cell products for therapy
Somatic cell products
Transport of somatic cells
Validation of cell shipping

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title = "Shipping of therapeutic somatic cell products",

abstract = "Background aims. Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products. Methods. Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility. Results. No consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight. Conclusions. This validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.",

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author = "Whiteside, {Theresa L.} and Griffin, {Deborah L.} and Joanna Stanson and William Gooding and McKenna, {David H} and Darin Sumstad and Kadidlo, {Diane M} and Adrian Gee and April Durett and Robert Lindblad and Deborah Wood and David Styers",

note = "Funding Information: This work was supported in part by PACT (NHLBI contract numbers N01-HB-37163, N01-HB-37164, N01-HB-37165 and N01-HB-37166 ). The authors would like to thank the staff at Baylor College of Medicine, University of Minnesota and the University of Pittsburgh for sample collection, shipping and testing. In addition, we would like to thank the EMMES Corporation for their assistance and dedication in bringing this manuscript to fruition. ",

year = "2011",

month = feb,

doi = "10.3109/14653249.2010.506507",

language = "English (US)",

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T1 - Shipping of therapeutic somatic cell products

AU - Whiteside, Theresa L.

AU - Griffin, Deborah L.

AU - Stanson, Joanna

AU - Gooding, William

AU - McKenna, David H

AU - Sumstad, Darin

AU - Kadidlo, Diane M

AU - Gee, Adrian

AU - Durett, April

AU - Lindblad, Robert

AU - Wood, Deborah

AU - Styers, David

N1 - Funding Information: This work was supported in part by PACT (NHLBI contract numbers N01-HB-37163, N01-HB-37164, N01-HB-37165 and N01-HB-37166 ). The authors would like to thank the staff at Baylor College of Medicine, University of Minnesota and the University of Pittsburgh for sample collection, shipping and testing. In addition, we would like to thank the EMMES Corporation for their assistance and dedication in bringing this manuscript to fruition.

PY - 2011/2

Y1 - 2011/2

N2 - Background aims. Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products. Methods. Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility. Results. No consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight. Conclusions. This validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.

AB - Background aims. Shipment of therapeutic somatic cells between a current good manufacturing practice (cGMP) facility and a clinic or between different cGMP facilities requires validated standard operating procedures (SOP). Under National Heart Lung & Blood Institute (NHLBI) sponsorship, the Production Assistance for Cellular Therapies (PACT) group conducted a validation study for the shipping SOP it has created, including shipments of cryopreserved somatic cells, fresh peripheral blood specimens and apheresis products. Methods. Comparisons of pre- and post-shipped cells and cell products at the three participating facilities included measurements of viability, phenotypic profiles and cellular functions. The data were analyzed at the University of Pittsburgh Biostatistics Facility. Results. No consistent shipping effects on cell viability, phenotype or functions were detected for cryopreserved and shipped peripheral blood mononuclear cells (PBMC), monocytes, immature dendritic cells (iDC), NK-92 or cytotoxic T cells (CTL). Cryopreserved mesenchymal stromal cells (MSC) had a significantly decreased viability after shipment, but this effect was in part because of inter-laboratory variability in the viable cell counts. Shipments of fresh peripheral blood and apheresis products for the generation of CTL and dendritic cells (DC), respectively, had no significant effects on cell product quality. MSC were successfully generated from fresh bone marrow samples shipped overnight. Conclusions. This validation study provides a useful set of data for guiding shipments of therapeutic somatic cells in multi-institutional clinical trials.

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KW - Transport of somatic cells

KW - Validation of cell shipping

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Shipping of therapeutic somatic cell products

Abstract

Bibliographical note

Keywords

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