scholarly journals Development and validation of real time polymerase chain reaction for detection DNA of pathogenic leptospira

2018 ◽  
Vol 32 (2) ◽  
pp. 565-576
Author(s):  
V. V. Ukhovskyi ◽  
L. M. Muzykina ◽  
I. V. Galka ◽  
V. G. Spyrydonov ◽  
I. I. Antonik ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Chain Reaction ◽  
Pathogenic Leptospira ◽  
Polymerase Chain ◽  
Development And Validation

Considerations in the development and validation of real-time quantitative polymerase chain reaction and its application in regulated bioanalysis to characterize the cellular kinetics of CAR-T products in clinical studies

Bioanalysis ◽  
2020 ◽  
Author(s):  
Tong-yuan Yang ◽  
Rajitha Doddareddy
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Method Development ◽  
Quantitative Polymerase Chain Reaction ◽  
Chain Reaction ◽  
Cellular Kinetics ◽  
Car T ◽  
Polymerase Chain ◽  
Development And Validation ◽  
Kinetics Of

Real-time quantitative polymerase chain reaction (qPCR) has become the standard method for monitoring cellular kinetics of CAR-T therapies with measurement of the CAR transgene copy numbers in peripheral blood mononuclear cells isolated from patients receiving the treatment. Unlike other biophysical and immunological methodologies for bioanalytical characterization of conventional small molecule drugs or protein biologics, there is no relevant regulatory guidance to date on the method development and validation for quantitative qPCR assays employed during clinical development of CAR-T products. This paper will provide an overview and considerations in the development and validation of a qPCR assay from sample extraction to assay parameters and its implementation in regulated bioanalysis for CAR-T or other types of cell therapies.

Development and validation of real-time polymerase chain reaction assays specific to four species of Eimeria

2008 ◽  
Vol 37 (1) ◽  
pp. 89-94 ◽  
Author(s):  
Damer P. Blake ◽  
Zonghua Qin ◽  
Jianping Cai ◽  
Adrian L. Smith
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Development And Validation

scholarly journals Development and validation of a Myxoma virus real-time polymerase chain reaction assay

2011 ◽  
Vol 24 (1) ◽  
pp. 135-137 ◽  
Author(s):  
Sarah Albini ◽  
Brigitte Sigrist ◽  
Regula Güttinger ◽  
Claude Schelling ◽  
Richard K. Hoop ◽  
...  
Keyword(s):  
Polymerase Chain Reaction ◽  
Real Time ◽  
Rapid Diagnosis ◽  
Myxoma Virus ◽  
The Novel ◽  
Specific Detection ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Development And Validation ◽  
Rabbit Tissues

To aid in the rapid diagnosis of myxomatosis in rabbits, a real-time polymerase chain reaction (PCR) for the specific detection of Myxoma virus is described. Primers and probe were designed to amplify a 147-bp fragment within the Serp2 gene. The assay was able to detect 23 copies of a synthesized oligo indicating a reliable sensitivity. In addition, the real-time PCR did not detect the Rabbit fibroma virus used in myxomatosis vaccines. The novel PCR was shown to be able to detect Myxoma virus in fresh and paraffin-embedded rabbit tissues originating from myxomatosis cases from various regions in Switzerland.

scholarly journals Development and Validation of a Quantitative Real-Time Polymerase Chain Reaction Classifier for Lung Cancer Prognosis

2011 ◽  
Vol 6 (9) ◽  
pp. 1481-1487 ◽  
Author(s):  
Guoan Chen ◽  
Sinae Kim ◽  
Jeremy M.G. Taylor ◽  
Zhuwen Wang ◽  
Oliver Lee ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Polymerase Chain Reaction ◽  
Real Time ◽  
Cancer Prognosis ◽  
Chain Reaction ◽  
Polymerase Chain ◽  
Development And Validation
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