PMID- 15496321
OWN - NLM
STAT- MEDLINE
DCOM- 20050428
LR  - 20191210
IS  - 0731-7085 (Print)
IS  - 0731-7085 (Linking)
VI  - 36
IP  - 2
DP  - 2004 Oct 29
TI  - Validation of the COSTIM bioassay for dendritic cell potency.
PG  - 285-94
AB  - Dendritic cells (DCs) are increasingly prepared in vitro for use in clinical 
      trials of human disease. Their utility in experimental immunotherapy has driven 
      significant advances in the manufacture of these cells. Thus it has become 
      imperative that, in concert with other quality control measures, a potency test 
      be utilized for the GMP/GLP lot-release of DC products for preclinical and 
      clinical studies. For this purpose we developed a novel method named the 'COSTIM 
      bioassay', which selectively measures co-stimulatory activity, or functional 
      potency of the DCs. In this method, T-cells stimulated with a sub-optimal amount 
      of anti-CD3 antibody are unable to proliferate unless a source of co-stimulation 
      (DCs) is added to the culture. We describe our validation of this method in this 
      paper.
FAU - Shankar, Gopi
AU  - Shankar G
AD  - Northwest Biotherapeutics, Inc., 22322, 20th Avenue SE, Bothell, WA 98021, USA. 
      gshanka3@cntus.jnj.com
FAU - Fourrier, Marc S
AU  - Fourrier MS
FAU - Grevenkamp, Michael A
AU  - Grevenkamp MA
FAU - Lodge, Patricia A
AU  - Lodge PA
LA  - eng
PT  - Journal Article
PT  - Validation Study
PL  - England
TA  - J Pharm Biomed Anal
JT  - Journal of pharmaceutical and biomedical analysis
JID - 8309336
RN  - 0 (BCG Vaccine)
RN  - 0 (Cancer Vaccines)
RN  - 0 (Indicators and Reagents)
SB  - IM
MH  - Antibody Specificity
MH  - B-Lymphocytes/immunology
MH  - BCG Vaccine/immunology
MH  - Biological Assay/*methods
MH  - Cancer Vaccines/therapeutic use
MH  - Dendritic Cells/*physiology
MH  - Drug Stability
MH  - Humans
MH  - Indicators and Reagents
MH  - Lymphocyte Culture Test, Mixed
MH  - Male
MH  - Monocytes/immunology
MH  - Prostatic Neoplasms/therapy
MH  - Quality Control
MH  - Reproducibility of Results
MH  - T-Lymphocytes/immunology
EDAT- 2004/10/22 09:00
MHDA- 2005/04/29 09:00
CRDT- 2004/10/22 09:00
PHST- 2004/03/07 00:00 [received]
PHST- 2004/05/26 00:00 [revised]
PHST- 2004/05/28 00:00 [accepted]
PHST- 2004/10/22 09:00 [pubmed]
PHST- 2005/04/29 09:00 [medline]
PHST- 2004/10/22 09:00 [entrez]
AID - S0731708504002584 [pii]
AID - 10.1016/j.jpba.2004.05.025 [doi]
PST - ppublish
SO  - J Pharm Biomed Anal. 2004 Oct 29;36(2):285-94. doi: 10.1016/j.jpba.2004.05.025.