Press Release Summary = Cellular Technology Ltd. has validated reference samples for use in human, pig, and mouse ELISPOT assay systems, which provides a sensitive tool for monitoring immune response.
Press Release Body = While long employed in the academic research setting, the ability to obtain valid ELISPOT data on study samples is beginning to greatly enhance ex vivo immune monitoring capabilities for the biotechnology and pharmaceutical industries. To be used in a regulated environment, however, the assay must be validated.
Based on years of research and development, Cellular Technology Ltd. has validated reference samples for use in human, pig, and mouse ELISPOT assay systems, which provides a sensitive tool for monitoring immune response. Validation has been accomplished through assay optimization by defining and documenting technical, biological, and reagent variables which can influence the ELISPOT assay. Furthermore, Cellular Technology Ltd. has achieved assay validation through accomplishing two phases. Phase I included the Qualification Experiments, which established the precise parameters and acceptance criteria for the validation experiment. Phase II then included the Validation Experiment and aimed to qualify one or more reference samples for use in a regulated study. By including both of these phases, the validation covered, but is not limited to, the following aspects of the assay structure including assay development, validation plan, validation test data, and validation report.
The ELISPOT systems capability to use frozen cells makes it possible to qualify reference samples, which can be used as a comparison in the pre-clinical and clinical studies. Cellular Technology Ltd. has developed test procedures to evaluate all key validation parameters, including, but not limited to, accuracy, precision, limits of detection, limits of quantitation, etc. Because it is sometimes difficult to find reference materials, specifically for human ELISPOT validation, CTL has developed a line of characterized and uncharacterized PBMCs for use a reference samples in human immune monitoring.
For further information on CTL's immune monitoring contract research service or reference samples, contact info@immunospot.com or call CTL at (216) 791-5084.
2022
