Our PHASEZERO® scientists apply 20 years of experience in immunohistochemical studies to provide Tissue Cross Reactivity (TCR) services to Good Laboratory Practice (GLP). Our team ensures that a tailored scientific approach results in the delivery of high quality data within defined timelines.
Quality of the tissue used affects the confidence in TCR study results. Our extensive human tissue biobank and supporting tissue supply network allows immediate access to all of the tissue types required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for TCR safety studies. Because we manage our own tissue network and have a team of board certified pathologists, we are able to provide our clients with the assurance that the well characterized tissues used in studies are of the highest quality. All tissues are acquired according to BioIVT’s ethics, consent and quality protocols and are stored in our repository for immediate access.
Our team will provide a custom service to meet the particular requirements for your therapeutic antibody or binding molecule (Test Item). Furthermore, we provide cost-effective assay development and validation studies for making confident decisions on the suitability and assay parameters to deploy for assessing your Test Item’s potential cross reactivity.
Lower the Risk with Three Phase Approach
Phase 1a: TCR Assay Optimization using positive/negative control tissues
We will work with you to select and if necessary provide suitable tissue (normal or diseased) or cell lines to deploy in the IHC assay development and validation. Thorough optimization of the experimental conditions increases confidence in the detection of specific binding of your test item.
Phase 1b:TCR pre-screening with Tissue Microarrays (optional)
We have created high quality, frozen tissue microarrays (TMAs) for an initial assessment of on-target and off-target binding of your biotherapeutic candidates. This TCR screening approach provides a cost-effective method to triage candidates prior to full GLP TCR studies.
Phase 2: GLP TCR Study on FDA/EMA-recommended tissue sections
The GLP TCR study is performed using the fully optimized and validated protocol established in Phase 1a using full-face sections of the 36 tissue types required by both the FDA and EMA. Additional tissues may also be included upon request.
GLP-Tissue Cross Reactivity
Tissue cross reactivity (TCR) is used to identify possible cross reactivity of novel biologicals with the aim of reducing the risk associated with first in patient testing. Regulatory requirements for assessing the safety of all new therapeutic antibodies are key to new therapy development. Our PHASEZERO Division works to the GLP principles of both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Because the two regulators are member of the Organization for Economic Co-operation and Development (OECD), data produced to their guidelines can also be accepted by Japanese authorities.
PHASEZERO is member of the GLP Compliance Monitoring Programme (Mar 2010) with commitments to quality management systems, excellent compliance and successful MHRA inspection in February 2015.
Features & Benefits
- Quality at source
- All tissues are specially qualified by us for use in GLP studies with respect to their quality and background clinical data.
- Services that meet your requirements
- Assay all 36 tissues recommended by both the FDA and EMA
- Twelve tissue types, 3 donors and duplicate cores per frozen TMA
- Three TMAs in total, each comprised of 72 cores (plus orientation cores)
- Rapid assessment of binding of potential biotherapeutic candidates
- Cost-effective, confident decision to progress a biotherapeutic to GLP TCR
- Minimize likelihood of GLP TCR study failure
- Enhanced confidence by validating assay protocol developed in Phase 1a
Advantages of Choosing PHASEZERO for GLP TCR
- Quick study turnaround
- Our access to tissue avoids delays awaiting scarce tissues
- Robust tissue qualification avoids time lost to experimental failures
- Confidence and peace of mind in the scientific integrity of the results
- Experienced scientific and pathology staff adept at even the most technically challenging assays
- Customized assay optimization for improved target detection
- Detailed and expert analysis of results
- Full Quality Assurance throughout the GLP process by our pharma experienced QA Director
- Full consultation and project management throughout the study