Tissue Cross-reactivity Studies

Tissue cross-reactivity (TCR) studies are an important aspect of pre-clinical development of therapeutic antibodies. Non-target specific binding to human tissue can result in serious consequences when pharmacologically active antibodies (Ab) are used to treat diseases. Therefore, prior to Phase I clinical trials, cross-reactivity studies of therapeutic Ab candidates are performed to identify cross-reactive or non-target tissue binding, which in turn provides important information about the immunological properties of the candidate antibody therapeutics.

Creative Biolabs' TCR services support the development of your candidate therapeutic antibodies by providing a powerful immunohistochemical assessment of potential cross-reactivity with a range of human tissue. Creative Biolabs has all the organizations defined in the relevant FDA and EMA guidelines, in fully compliant with local legal regulations and ethical norms.

Process Overview: TCR testing at Creative Biolabs

A. For initial characterization and optimization, the optimal specificity and staining conditions of the experimental antibodies are determined. We will work with you to thoroughly optimize the experimental conditions to increase the credibility of the specific combination of test and test items.

B. We have created a high quality Frozen Tissue Microarray (TMA) for initial assessment of targeted and off-target binding of your biotherapeutic candidates. Tissue sections are treated with positive control antibodies to ensure their antigenicity and H&E staining after fixation to confirm identity and suitability for inclusion in the TCR study.

TCR Assay Optimization

Preliminary Screening

TCR Studies

GLP Regulatory

C. The GLP TCR study is performed using the fully optimized and validated protocol that is established in Phase I using full-face sections of the 36 tissue types required by both the FDA and EMA. Additional tissue may also be included upon request.

■ Full compliance with GLP regulations
■ Full range of human FDA/EMA recommended tissue
■ 3 unrelated donors
■ Minimum of 2 antibody concentrations
■ Inclusion of positive and negative control antibodies and tissue
■ Automated IHC processing for reduced assay variability
■ Full reports including quality statement and high resolution representative digital images
■ Expert pathologist review in compliance with GLP regulations

Our team follows the GLP principles of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). TCR studies can be tailored to your requirements.

For more details, please feel free to contact us or send us a query directly.