Tissue Cross Reactivity

Asterand Bioscience applies 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 at Source

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 Asterand Bioscience’s ethics, consent and quality protocols and are stored in our repository for immediate access.

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

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 risk using our three phase approach

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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.

  • Assay 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 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

 

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.
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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. Asterand Bio works to the GLP principles of both the FDA and European medicines agency. 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 the Japanese authorities.

Asterand Bio 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.glp-regulatory-panels

Asterand Bio’s GLP TCR Panel

The FDA and EMA have defined tumor tissue panels for use in tissue cross reactivity safety assessments. Our existing collection of these tissues include representative samples from 3 male and 3 female donors. All tissues are pre-qualified as suitable and of the highest quality for GLP studies.

Asterand Bio also offers a non-GLP TCR Screen that is TMA-based. Thus, allowing for the prioritization of novel therapeutic antibodies for full GLP TCR and further development in frozen TMA containing the full range of GLP tissues, all from three individual donors.
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FDA/EMA Required Tissue Types

 

TCR

①  Asterand Bio has expanded the required tissue list for uterus and lung as both tissue types have a known variance of expression in their tissue subtypes.

②  Blood cells and blood vessels are examined within the tissue cohort and therefore not included as separate  entities.

Advantages of Choosing Asterand Bioscience 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

More on GLP TCR.

 

For further information, or to discuss a specific study, please contact us at advantage@asterandbio.com.