-
1
-
-
84979266985
-
-
U.S. Food and Drug Administration, Accessed 4 Nov 2015
-
Facts About the Current Good Manufacturing Practices (CGMPs) (2005) U.S. Food and Drug Administration. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm. Accessed 4 Nov 2015
-
(2005)
-
-
-
2
-
-
84979285793
-
-
uropean Medicines Agency., Accessed 4 Nov 2015
-
Good-manufacturing-practice and gooddistribution- practice compliance (2015) European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000154.jsp. Accessed 4 Nov 2015
-
(2015)
-
-
-
3
-
-
84979285791
-
-
World Health Organization, Accessed 4 Nov 2015
-
Biologicals: Good Manufacturing Practices (2015) World Health Organization, http://www.who.int/biologicals/vaccines/good_manufacturing_practice/en/. Accessed 4 Nov 2015
-
(2015)
-
-
-
4
-
-
84870005205
-
-
Guidance for Industry: CGMP for Phase 1 Investigational Drugs (2008) http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070273.pdf
-
(2008)
CGMP for Phase 1 Investigational Drugs
-
-
-
6
-
-
84979225276
-
-
Chemistry, Manufacturing, and Control Information
-
Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (2012) http://www.fda.gov/downloads/BiologicsBloodVaccines/Guidance-ComplianceRegulatoryInformation/Guidances/General/UCM292704.pdf
-
(2012)
Early Clinical Trials with Live Biotherapeutic Products
-
-
-
8
-
-
77957300466
-
Good manufacturing practice-compliant cell sorting and large-scale expansion of single KIR- positive alloreactive human natural killer cells for multiple infusions to leukemia patients
-
Siegler U, Meyer-Monard S, Jorger S et al (2010) Good manufacturing practice-compliant cell sorting and large-scale expansion of single KIR- positive alloreactive human natural killer cells for multiple infusions to leukemia patients. Cytotherapy 12:750-763
-
(2010)
Cytotherapy
, vol.12
, pp. 750-763
-
-
Siegler, U.1
Meyer-Monard, S.2
Jorger, S.3
-
9
-
-
49449099583
-
Umbilical cord mesenchymal stem cells increase expansion of cord blood natural killer cells
-
Boissel L, Tuncer HH, Betancur M et al (2008) Umbilical cord mesenchymal stem cells increase expansion of cord blood natural killer cells. Biol Blood Marrow Transplant 14:1031-1038
-
(2008)
Biol Blood Marrow Transplant
, vol.14
, pp. 1031-1038
-
-
Boissel, L.1
Tuncer, H.H.2
Betancur, M.3
-
10
-
-
68049132603
-
Clinical-grade ex vivo-expanded human natural killer cells up-regulate activating receptors and death receptor ligands and have enhanced cytolytic activity against tumor cells
-
Berg M, Lundqvist A, McCoy P Jr et al (2009) Clinical-grade ex vivo-expanded human natural killer cells up-regulate activating receptors and death receptor ligands and have enhanced cytolytic activity against tumor cells. Cytotherapy 11:341-355
-
(2009)
Cytotherapy
, vol.11
, pp. 341-355
-
-
Berg, M.1
Lundqvist, A.2
McCoy, P.3
-
11
-
-
33845944538
-
Tumor- primed human natural killer cells lyse NK-resistant tumor targets: Evidence of a twostage process in resting NK cell activation
-
North J, Bakhsh I, Marden C et al (2007) Tumor- primed human natural killer cells lyse NK-resistant tumor targets: evidence of a twostage process in resting NK cell activation. J Immunol 178:85-94
-
(2007)
J Immunol
, vol.178
, pp. 85-94
-
-
North, J.1
Bakhsh, I.2
Marden, C.3
-
12
-
-
3042837951
-
A Wilms tumor cell line, HFWT, can greatly stimulate proliferation of CD56+ human natural killer cells and their novel precursors in blood mononuclear cells
-
Harada H, Watanabe S, Saijo K et al (2004) A Wilms tumor cell line, HFWT, can greatly stimulate proliferation of CD56+ human natural killer cells and their novel precursors in blood mononuclear cells. Exp Hematol 32:614-621
-
(2004)
Exp Hematol
, vol.32
, pp. 614-621
-
-
Harada, H.1
Watanabe, S.2
Saijo, K.3
-
13
-
-
65949111530
-
Expansion of highly cytotoxic human natural killer cells for cancer cell therapy
-
Fujisaki H, Kakuda H, Shimasaki N et al (2009) Expansion of highly cytotoxic human natural killer cells for cancer cell therapy. Cancer Res 69:4010-4017
-
(2009)
Cancer Res
, vol.69
, pp. 4010-4017
-
-
Fujisaki, H.1
Kakuda, H.2
Shimasaki, N.3
-
14
-
-
84862908673
-
Membrane-bound IL-21 promotes sustained Ex vivo proliferation of human natural killer cells
-
Denman CJ, Senyukov VV, Somanchi SS et al (2012) Membrane-bound IL-21 promotes sustained Ex vivo proliferation of human natural killer cells. PLoS One 7, e30264
-
(2012)
Plos One
, vol.7
-
-
Denman, C.J.1
Senyukov, V.V.2
Somanchi, S.S.3
-
15
-
-
84979267030
-
-
Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals (1993) http://www.fda.gov/downloads/biologicsbloodvaccines/safetyavailability/ucm162863.pdf
-
(1993)
-
-
-
16
-
-
0031407119
-
-
Medicinal and other products and human and animal transmissible spongiform encephalopathies: memorandum from a WHO meeting (1997). Bull World Health Organ 75:505-513
-
(1997)
Bull World Health Organ
, vol.75
, pp. 505-513
-
-
-
17
-
-
84979229725
-
-
uropean Commission, ed), Official Journal of the European Union
-
Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMA/410/01 rev.3) (2011) (European Commission, ed), Official Journal of the European Union http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003700.pdf
-
(2011)
-
-
-
18
-
-
84979205975
-
-
Bovine Spongiform Encephalopathy (BSE) Questions and Answers (2015) http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm111482.htm
-
(2015)
-
-
-
19
-
-
36348946918
-
No alloantibodies against mesenchymal stromal cells, but presence of anti-fetal calf serum antibodies, after transplantation in allogeneic hematopoietic stem cell recipients
-
Sundin M, Ringden O, Sundberg B et al (2007) No alloantibodies against mesenchymal stromal cells, but presence of anti-fetal calf serum antibodies, after transplantation in allogeneic hematopoietic stem cell recipients. Haematologica 92:1208-1215
-
(2007)
Haematologica
, vol.92
, pp. 1208-1215
-
-
Sundin, M.1
Ringden, O.2
Sundberg, B.3
-
20
-
-
22044435932
-
Guidance on good cell culture practice. A report of the second ECVAM task force on good cell culture practice
-
Coecke S, Balls M, Bowe G et al (2005) Guidance on good cell culture practice. a report of the second ECVAM task force on good cell culture practice. Altern Lab Anim 33:261-287
-
(2005)
Altern Lab Anim
, vol.33
, pp. 261-287
-
-
Coecke, S.1
Balls, M.2
Bowe, G.3
-
21
-
-
84899649655
-
Clinical grade purification and expansion of natural killer cells
-
Lapteva N, Szmania SM, van Rhee F et al (2014) Clinical grade purification and expansion of natural killer cells. Crit Rev Oncog 19:121-132
-
(2014)
Crit Rev Oncog
, vol.19
, pp. 121-132
-
-
Lapteva, N.1
Szmania, S.M.2
van Rhee, F.3
-
22
-
-
0027227586
-
Differential effect of cryopreservation on natural killer cell and lymphokine-activated killer cell activities
-
Marti F, Miralles A, Peiro M et al (1993) Differential effect of cryopreservation on natural killer cell and lymphokine-activated killer cell activities. Transfusion 33:651-655
-
(1993)
Transfusion
, vol.33
, pp. 651-655
-
-
Marti, F.1
Miralles, A.2
Peiro, M.3
-
24
-
-
84905970560
-
Therapeutic applications: Natural killer cells in the clinic
-
Miller JS (2013) Therapeutic applications: natural killer cells in the clinic. Hematology Am Soc Hematol Educ Program 2013:247-253
-
(2013)
Hematology am Soc Hematol Educ Program
, vol.2013
, pp. 247-253
-
-
Miller, J.S.1
-
25
-
-
84873408416
-
-
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), ed
-
Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products (2011) (U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER), ed)
-
(2011)
Potency Tests for Cellular and Gene Therapy Products
-
-
-
26
-
-
84949460648
-
A novel method for assessment of natural killer cell cytotoxicity using image cytometry
-
Somanchi SS, McCulley KJ, Somanchi A et al (2015) A novel method for assessment of natural killer cell cytotoxicity using image cytometry. PLoS One 10, e0141074
-
(2015)
Plos One
, vol.10
-
-
Somanchi, S.S.1
McCulley, K.J.2
Somanchi, A.3
-
27
-
-
84911390603
-
Antibody Fc-engineering improves frequency and promotes kinetic boosting of serial killing mediated by NK cells
-
Romain G, Senyukov V, Rey-Villamizar N et al (2014) Antibody Fc-engineering improves frequency and promotes kinetic boosting of serial killing mediated by NK cells. Blood 124(22):3241-3249
-
(2014)
Blood
, vol.124
, Issue.22
, pp. 3241-3249
-
-
Romain, G.1
Senyukov, V.2
Rey-Villamizar, N.3
-
28
-
-
77952430182
-
Identifying candidate allogeneic NK-cell donors for hematopoietic stem-cell transplantation based on functional phenotype
-
Hurton LV, Siddik RI, Singh H et al (2010) Identifying candidate allogeneic NK-cell donors for hematopoietic stem-cell transplantation based on functional phenotype. Leukemia 24:1059-1062
-
(2010)
Leukemia
, vol.24
, pp. 1059-1062
-
-
Hurton, L.V.1
Siddik, R.I.2
Singh, H.3
|