June 2009    

Antibody Cross-Reactivity Studies at Comparative Biosciences

Did you know that when submitting an IND for a therapeutic biological molecule, the FDA now requires that all monoclonal antibodies and other biologics undergo tissue cross-reactivity testing? This is necessary to ensure that the antibody does not bind to receptors or other epitopes in addition to the intended target.

In addition, non-GLP, or experimental Tissue Cross-Reactivity studies, is a key tool used to identify potential species for GLP toxicology studies for IND submission.

Comparative Biosciences, Inc conducts Tissue Cross-Reactivity studies in accordance with the F.D.A.s’ guidance document, "Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use," under GLP guidelines.

Tissue Cross-Reactivity Studies are comprised of three distinct phases, often preceded by a staining method development phase:

Phase I - Antibody Preparation and Characterization

Phase II - Preliminary TCR Screen: Intended to identify potential cross-reactivity issues prior to conducting the full screen.

Phase III - Comprehensive TCR Screen: Both the test and IgG isotype control antibodies are used at a high and a low concentration to immunolabel 3 individual specimens each of the approximately 33 frozen normal tissue types recommended by the FDA.

promo 1 promo2 promo3

Comparative Biosciences, Inc. TCR services include:

  • Staining method development abilities
  • State-of-the-art facility and equipment for the sectioning and staining of a full range of frozen, resin, and paraffin samples
  • Fully validated human, primate, and other species’ tissue banks from multiple donors, with patient history (human only)
  • A full range of positive, negative, and specific absorption assay controls
  • Wide expertise in immunohistological procedures using dedicated, highly experienced IHC technicians
  • DAKO Austostainers for rapid, uniform staining of tissues
  • Evaluation of results by fully qualified board certified and board eligible veterinary pathologists
  • A reporting process designed to meet your requirements with digitized photographic images in hard-copy GLP audited reports
  • Fully audited Quality Assurance programs covering technical procedures and reporting
  • Full study reports suitable for regulatory submission
  • See for yourself - our clients are welcome in our facility to evaluate representative tissue samples from their study with one of our experienced pathologists.

Contact Taylor Norwitt, Business Development Manager today at 408-504-8871 to schedule a tour or to discuss your TCR study requirements.