Validation overview of bio-analytical methods

Tuomela, Mari; Stănescu, Ioana; Krohn, Kai

doi:10.1038/sj.gt.3302627

Cited by 31 publications

(26 citation statements)

References 19 publications

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“…The linearity was further improved with a narrower range of 60 120% of the test concentration, for which the coefficient of determination (R 2 ) was 0.997. The result falls within the commonly-accepted range of about 25% RSD for cell based potency assays (Tuomela et al 2005). Similar results have been obtained during assay validation after the assay was transferred to a QC laboratory (Waerner et al 2007).…”

Section: Quantitative Potency Assaysupporting

confidence: 69%

Development of potency assays for a plasmid containing vascular endothelial growth factor 2

Huang¹,

Chin²,

Chiang³

2010

Electro Journal of Biotech

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Section: Quantitative Potency Assaysupporting

confidence: 69%

Development of potency assays for a plasmid containing vascular endothelial growth factor 2

Huang¹,

Chin²,

Chiang³

2010

Electro Journal of Biotech

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“…whole-blood-and PBMC-based MGIA. Tuomela et al suggest that for assay validation a CV of less than 50% is acceptable variation for the measurement of a bacterial target of a cell-based assay (21). In this report, both the whole-blood and the PBMC MGIA had a CV of less than 50% over repeated sampling prior to immunization.…”

Section: Discussionmentioning

confidence: 67%

Inhibition of Mycobacterial GrowthIn Vitrofollowing Primary but Not Secondary Vaccination with Mycobacterium bovis BCG

Fletcher

Tanner

Wallis

et al. 2013

Clin Vaccine Immunol

108

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h Despite the widespread use of the Mycobacterium bovis BCG vaccine, there are more than 9 million new cases of tuberculosis (TB) every year, and there is an urgent need for better TB vaccines. TB vaccine candidates are selected for evaluation based in part on the detection of an antigen-specific gamma interferon (IFN-␥) response. The measurement of mycobacterial growth in blood specimens obtained from subjects immunized with investigational TB vaccines may be a better in vitro correlate of in vivo vaccine efficacy. We performed a clinical study with 30 United Kingdom adults who were followed for 6 months to evaluate the abilities of both a whole-blood-and a novel peripheral blood mononuclear cell (PBMC)-based mycobacterial growth inhibition assay to measure a response to primary vaccination and revaccination with BCG. Using cryopreserved PBMCs, we observed a significant improvement in mycobacterial growth inhibition following primary vaccination but no improvement in growth inhibition following revaccination with BCG (P < 0.05). Mycobacterial growth inhibition following primary BCG vaccination was not correlated with purified protein derivative (PPD) antigen-specific IFN-␥ enzyme-linked immunospot (ELISPOT) responses. We demonstrate that a mycobacterial growth inhibition assay can detect improved capacity to control growth following primary immunization, but not revaccination, with BCG. This is the first study to demonstrate that an in vitro growth inhibition assay can identify a difference in vaccine responses by comparing both primary and secondary BCG vaccinations, suggesting that in vitro growth inhibition assays may serve as better surrogates of clinical efficacy than the assays currently used for the assessment of candidate TB vaccines.

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“…Since both antigens (Hsp65 and Ag85) have been frequently used by different laboratories around the world with repeated success in different models (12)(13)(14)(15)(16)(17)(18)(19)(20)(21), it is possible that the type of lesions observed by Turner (24) and Taylor (25-26) et al could be an isolated phenomenon. This could possibly be due to the contamination of the vaccines with endotoxin (30), a problem that we excluded through the production of plasmids with endotoxin levels that are in accordance with US and European guidelines (34).…”

Section: Discussionmentioning

confidence: 99%

No Evidence of Pathological Autoimmunity following Mycobacterium Leprae Heat-Shock Protein 65-Dna Vaccination in Mice

et al. 2009

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Heat-shock proteins (HSPs) are currently one of the most promising targets for the development of immunotherapy against tumours and autoimmune disorders. This protein family has the capacity to activate or modulate the function of different immune system cells. They induce the activation of monocytes, macrophages and dendritic cells, and contribute to cross-priming, an important mechanism of presentation of exogenous antigen in the context of MHe class I molecules. These various immunological properties of HSP have encouraged their use in several clinical trials. Nevertheless, an important issue regarding these proteins is whether the high homology among HSPs across different species may trigger the breakdown of immune tolerance and induce autoimmune diseases. We have developed a DNA vaccine codifying the Mycobacterium /eprae Hsp65 (DNAhsp65), which showed to be highly immunogenic and protective against experimental tuberculosis. Here, we address the question of Whether DNAhsp65 immunization could induce pathological autoimmunity in mice. Our results show that DNAhsp65 vaccination induced antibodies that can recognize the human Hsp60 but did not induce harmful effects in 16 different organs analysed by histopathology up to 210 days after vaccination. We also showed that anti-DNA antibodies were not elicited after DNA vaccination. The results are important for the development of both HSP and DNA-based immunomodulatory agents. 1721-727X (2009) Copyright© by DlOLlFE.8.8.s. This publicationand/or article is for individualuse only and may not be further reproducedwithout written permissionfrom the copyrightholder. Unauthorizedreproductionmay result in financial and other penalties 77The dual roles ofheat-shock proteins (HSPs) in the (I). Due to their potential use as immunomodulators in immune system are still a matter of scientific debate a variety of pathological processes, special attention

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Validation overview of bio-analytical methods

Cited by 31 publications

References 19 publications

Development of potency assays for a plasmid containing vascular endothelial growth factor 2

Development of potency assays for a plasmid containing vascular endothelial growth factor 2

Inhibition of Mycobacterial GrowthIn Vitrofollowing Primary but Not Secondary Vaccination with Mycobacterium bovis BCG

No Evidence of Pathological Autoimmunity following Mycobacterium Leprae Heat-Shock Protein 65-Dna Vaccination in Mice

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