Blog Archives
05/07/2012
Tags:
Assay Automation,
Assay Standardization,
Biomarker,
Biotech,
Cell Mediated Immune Assays,
Drug Development,
Immune Monitoring,
PharmaThe need to implement robust biomarkers in clinical trials has never been greater, and such efforts can be easily compromised by reagent instability or simple human error during assay set-up. Many biotechnology and pharmaceutical companies are introducing efforts to conduct biomarker studies under more rigorous settings, and the use of plates or tubes pre-loaded with stimulation or staining reagents could be of value for studies that involve flow cytometry.
The value of this approach is that it lends itself to assay automation easily and safeguards against omission or erroneous addition of bulk liquid formulations of PMA and ionomycin to the reaction vessel (i.e., plate or tube) and also lends itself to extended stability/shelf-life of these reagents. On the basis of this initial success, we plan to expand our evaluation of lyophilized reagents so that they can be incorporated into our clinical biomarker campaigns as appropriate.
11/01/2011
Tags:
Immune MonitoringWorking together, ImmunoSite Technologies and Goodwin Biotechnology companies offer enhanced abilities to develop, test and manufacture biopharmaceuticals
09/27/2011
Tags:
Cell Mediated Immune Assays,
clinical research,
Immune Monitoring,
IST Partnerships,
Vaccine DevelopmentWorking together, companies offer enhanced abilities to monitor immunotherapy response in vaccine and drug studies.
08/23/2011
Tags:
Assay Automation,
Assay Standardization,
Biotech,
Clinical Trials,
Drug Development,
Immune MonitoringThe identification and application of correlates of immune response can enable significant time and money savings especially in clinical trial settings for vaccine and biologic R&D. To download, please fill in the form below: [email-download download_id="2" contact_form_id="3"]
03/11/2011
Tags:
Drug Development,
Immune Monitoring,
Immunogenicity,
Surrogate Markers of Efficacy,
Vaccine Development
It is of concern of all in pharma and biotech research fields that the number of vaccines and drugs that get to the market is very low compared to the number that enter phase I clinical trial testing. For this to change, among other improvements, new surrogate markers must be identified early on for the purpose of patient stratification, immune monitoring and/or therapeutic or prophylactic efficacy assessment.
03/10/2011
Tags:
Assay Standardization,
Cell Mediated Immune Assays,
Clinical Trials,
Correlates of Immunity,
Immune Monitoring
How practical is it to run validated and standardized cellular assays to interrogate biomarker surrogate correlates of immunity in clinical trial settings? Can this be done with any level of confidence in the outcome? Can these assays be performed routinely?
01/14/2011
Tags:
Assay Automation,
Drug Development,
Drug Discovery,
Immune Monitoring,
IST Partnerships,
ServicesWhat Do You Seek In A Contract Research Partnership? In a time of tight budgets and careful examination of the cost/benefit of partnering with a contract research service provider, ImmunoSite Technologies, LLC (IST) offers a rare combination of experience, knowledge, responsiveness, and trustworthiness. IST knows what clients need to be successful, and how to […]
01/11/2011
Tags:
Cell Mediated Immune Assays,
Immune MonitoringDr. Wade E. Bolton, president & CEO of ImmunoSite Technologies, moderated a special session on Cell Mediated Immunity (CMI) at the Phacilitate Vaccine Forum in Washington, DC, on Tuesday, January 25, 2011. Topics included: Do you want standardized assays to interrogate surrogate correlates of immunity? Do you need high-throughput, validated, and automated assays to measure immunogenicity? […]
01/10/2011
Tags:
Assay Automation,
Assay Standardization,
Biomarker,
clinical research,
Clinical Trials,
Drug Development,
Immune MonitoringReaders gain an understanding of the details and the high level considerations of assay qualification for difficult cell-based assays. The level of optimization described for cell-based assays lends itself to biomarker assay automation which can be used for biomarker qualification and validation studies to the satisfaction of the FDA, EMEA, and other regulatory agencies.
Cell-based assay platforms covered are flow cytometry, intracellular cytokine ICS, immunophenotyping, elispot, IHC, cylex, neutralization bioassays, and endpoint assays.
