Guidelines issued by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the development of therapeutic antibodies and related products recommend their testing for tissue cross reactivity (TCR) on a range of human tissues.
Precision for Medicine’s scientific team can perform TCR screening studies using frozen tissue microarrays, or fully good laboratory practice (GLP)-compliant TCR studies suitable for Investigational New Drug (IND) submission.
Tailored methodology for biotherapeutic tissue cross-reactivity studies
Precision for Medicine’s unique combination of research services and tissue procurement capabilities form the pillars of our TCR Services.
Tissue cross–reactivity study services
Combined with a tailored scientific approach, Precision’s expertise in immunohistochemistry (IHC) assay development for a range of biotherapeutic modalities enables us to deliver high quality data to our clients in a defined time period.
- Assay development and optimization
- Confirmation of tissue antigenicity
- TCR screening using frozen tissue microarrays for rapid data delivery prior to fully GLP-compliant studies
- GLP tissue cross reactivity studies utilizing all 36 required human tissue types
- Fully automated IHC assays
- Medicines and Healthcare products Regulatory Agency (MHRA) GLP certified facility
- In-house pathology services
Qualified biospecimens for tissue cross-reactivity studies
- Robust qualification of tissues from procurement to assay use
- Non-GLP tissue microarray (TMA)
- GLP full-face sections of 36 human tissue types
Tissue Types Available for GLP TCR Studies
Precision for Medicine is a leading supplier of well-characterized biospecimens for research—all collected through a global network of healthcare specialists. All human tissues recommended for TCR testing by the FDA and the EMA are fully consented for commercial research, and available from at least 3 male and 3 female donors.
Precision’s 3-Phase Approach to TCR Testing
Integrating biomarker and clinical trial data
To help researchers understand and interpret biomarker assay data in the context of other assays as well as the clinical trial data, Precision manages all assay data using our proprietary QuartzBio® Translational Informatics platform.
Learn more about the sample management, informatics, and computational capabilities of QuartzBio®.
Working with Precision
Precision’s specialty lab scientists take collaborative and consultative approaches to projects and can provide recommendations on biomarker assay strategies and implementation. Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.
Precision’s immunohistochemistry (IHC) services can be customized based on study needs, and can include development of logistical processes, kitting, special stains, and creation of a custom assay and scoring system.
Our in-house pathology team can provide expert assessments with rapid turn-around times, and has a full suite of sample processing services including formalin-fixed, paraffin-embedded (FFPE) and microdissection for genomics applications.
We offer automated multiplex immunofluorescence (mIF) services that enable quantitative visualization of as many as 9 markers in tissue and liquid biopsies, and individual cells. mIF can be integrated with other methods including co-analysis using fluorescent in situ hybridization/in situ hybridization (FISH/ISH).