One of FOCUS Immunology’s key services is immune-monitoring in clinical trials.
In the presentation basic options of this service are outlined.
Please note that this is not a standard procedure, but that the actual procedures and parameters will be tailored to the specific needs of a given clinical trial.
FOCUS Immunology’s experts are looking forward to discuss this in detail with you.
Contact:
Dr. Eddy Bruyns, Ph.D.
Telephone: +49 6221 649 350
Email:eddy.bruyns@focus-cdd.com
Dr. Eddy Bruyns, FOCUS Immunology, has provided a white paper on FOCUS Immunologies‘ pre-analytical services. He addresses aspects of sample collection, processing and shipment in clinical trials.
He points out procedures that allow cell preparation and transportation for functional analysis in international multi-center trials as well as procedures for collection, transportation and central testing of whole blood sample for flow cytometry.
You may download the white paper here.
FOCUS Immunology has developed methods for on-site isolation of immune cells from peripheral blood, their transportation to Heidelberg, and subsequent functional testing under conditions of international multicenter clinical trials.
In a recent project patients were recruited at medical centers in several countries. At these sites FOCUS implemented its robust and simple protocol for on-site cell preparation. Then FOCUS organised the controlled transportation of the cells to the central testing laboratory in Heidelberg, Germany.
Incoming samples were QC-ed, and cytokine production as well as proliferation was determined in cultures of the isolated immune cells together with various defined stimuli of immune functions.
It took FOCUS only 6 weeks to implement standardized sample generation, sample logistics and testing.
The studies led to further understanding of the compound’s mode-of-action.
FOCUS Immunology offers immune monitoring tailored to the needs of given clinical trial protocols. For further information please contact immunology@focus-cdd.com or contact directly FOCUS’ Head of the Immunology Laboratory Dr. Eddy Bruyns at eddy.bruyns@focus-cdd.com, Tel.: +49 (0) 6221 649 35 124.
Biologicals used as therapeutics may induce unwanted immune responses in treated patients. Thus, the EMEA has recently issued a guideline for immunogenicity assessment. Immunogenicity testing should be part of clinical efficacy and safety studies.
Key elements of the EMEA recommendations in brief: Immunogenicity should be evaluated in all study participants and not only in symptomatic individuals. Bioassays for neutralizing antibodies need to be designed in a product-dependent manner. Clear criteria have to be defined to distinguish positive from negative findings and to confirm positive results.
FOCUS Immunology supports its clients to integrate these recommendations into their repsective clinical trial protocols. FOCUS’ services comprise assay development and validation for preclinical and clinical studies, testing under GLP conditions, implementation of confirmatory assays, development of bioassays for testing of neutralising antibodies and sample logistics in international multicenter trials.
If you have questions or want to discuss immunogenicity testing in your specific development project, please do not hesitate to contact our Head of the Immunology Laboratory Dr. Eddy Bruyns via email (eddy.bruyns@focus-cdd.com) or via telephone (+49 6221 649 35 124).
The current EMEA guideline on immunogenicity testing can be found here.
FOCUS used the expertise of its Heidelberg-based subsidiary FOCUS Immunology in an international multi-center clinical trial that required the isolation of immune cells from peripheral blood, their transportation and subsequent testing for cellular functions.
Patients were recruited at medical centers in different countries. FOCUS established a robust and simple protocol for standardized on-site cell preparation and organised the controlled transportation of the cells to the central testing laboratory in Heidelberg.
After appropriate quality control of in-coming samples, isolated immune cells were cultured and tested for various functions including cytokine production and proliferation.
The preparation and implementation of standardized sample generation, sample logistics and testing was completed within 6 weeks.
The studies led to further understanding of patient characteristics and the compound’s mode-of-action.
For further information contact FOCUS’ Head of Immmunology laboratory Dr. Eddy Bruyns via eddy.bruyns@focus-cdd.com or +49 (0) 649 35 124.
Monday, January 25, 2010
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