How Immunohistochemistry and Immunofluorescence Benefit Pre-Clinical and Clinical Research

What is Immunohistochemistry and Immunofluorescence?

Immunohistochemistry (IHC) and immunofluorescence (IF) are molecular assays that involve the use of antibodies to detect specific proteins within tissues on microscope slides. Unlike other antibody assays, immunohistochemistry allows researchers to visualize exactly where proteins are localized within tissues (specific cell types and subcellular localization; cell membrane, cytoplasm or nuclear). Providing cellular identity within the context of the tissue allows pathologists to identify which cells within that tissue are expressing the protein. The FDA and other worldwide regulatory agencies are increasingly interested in biomarker investigations supporting efficacy and safety endpoints in submissions such as INDs and BLAs. By using a panel of immune cell markers, for example, a result of “inflammation by T cells was observed” by the H&E becomes “inflammation with CD8+ cytotoxic T cells was observed.”

 How are immunohistochemistry and immunofluorescence helpful?

Immunohistochemistry can be used to determine the lineage of neoplasms that are identified in routine H&E sections. Additional markers may be used to further identify tumor origin and markers such as Ki67 or PCNA, which can be used to determine how rapidly neoplastic cells are proliferating. Immunohistochemistry can also be used to distinguish apoptosis from necrosis and endothelial cell markers, such as CD31, can be used to evaluate tumor angiogenesis. In Tissue Cross-Reactivity Studies, IHC provides the ability to map the presence of targets across many tissues with the use of Tissue Micro Arrays (TMAs).

Can IHC and IF reduce timelines and create value? 

Research done properly utilizing IHC and IF leveraging the right experience and expertise will ensure proper study design and marker selection, samples that provide clear data, and pathology reports that accurately evaluate study results. The quality and consistency of slide production means less time spent on trial and error to ensure quality results and meeting project deadlines while reducing hidden costs of extensive marker optimization work—less trial and error, equipment costs and maintenance and expensive reagent costs for small and diverse studies. Finally, this research in the right hands means met timetables and deadlines, ensuring on-time research and decreased time to market.

Register for this webinar to learn about the benefits of including IHC and IF in pre-clinical and clinical research.

Speakers

Dr. Elizabeth Hutto, DVM, PhD, DACVP, Senior Director of Investigative Pathology, StageBio

Dr. Hutto has supported academic institutions and pharmaceutical and biotechnology companies with non-clinical veterinary pathology expertise, leveraging experience in study design, animal model selection and evaluation, and data interpretation for GLP and non-GLP studies. As Director of Investigative Pathology for StageBio, Dr. Hutto uses specialty investigative techniques, including immunohistochemistry, immunofluorescence, and morphometry. Dr. Hutto earned her DVM from Tufts University School of Veterinary Medicine in 1994 and became a Diplomate of the American College of Veterinary Medicine in 2001. In 2004, she earned her PhD from the University of Connecticut.

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Dr. Matt Buccellato, DVM, PhD, DACVP, Senior Pathologist, StageBio

Dr. Buccellato has supported a wide variety of research on animal species in dose range-finding, sub-chronic, and chronic studies. He has served as lead pathologist for pharmaceutical efficacy and preclinical toxicity studies and has extensive experience aiding the development of therapies for a number of bacterial and viral pathogens and chemical agents. Dr. Buccellato earned his DVM from North Carolina State University in 2001, then completed his residency in Anatomic Pathology and received his PhD from The Ohio State University in 2008. He became a Diplomate of the American College of Veterinary Pathologists in 2008.

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Dr. Thomas Lemarchand, Director of Digital and Quantitative Pathology, StageBio

Dr. Thomas Lemarchand performed research in molecular and immunopathology in disease models and worked in pharmaceutical companies, before leveraging this experience in both GLP safety and pharmacology non-GLP studies in CROs. As Director of Digital and Quantitative Pathology at StageBio, Dr. Lemarchand routinely uses in situ hybridization, immunohistochemistry, immunofluorescence and morphometry in studies. He earned his DEDV (DMV) from Nantes University School of Veterinary Medicine in 1992, completed pathology training in 1993 in Montreal and earned his PhD from Louisiana State University in 2000. He became a Diplomate of the European College of Veterinary Medicine in 2015.

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