Tissue Cross Reactivity

As part of the investigational new drug (IND) application procedure, all therapeutic monoclonal antibodies or other biological molecules are required to be tested for in vitro cross-reactivity (tissue cross-reactivity testing). This is performed as outlined in the FDA document “Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use”.

I really appreciate your flexibility to work within our timelines; thanks again for all of your hard work~ MN client

HSRL offers tissue cross-reactivity studies, both GLP and non-GLP (including screening studies), human and non-human species, in support of preclinical therapeutic antibody development.

Dr. Joan Wicks

Dr. Joan Wicks, Director of Investigative Pathology, supervises the Tissue Cross-Reactivity studies at HSRL. Dr. Wicks, an ACVP board-certified veterinary pathologist, has research, pharmaceutical, and CRO-based experience, and has served as a Study Director and Study Pathologist for numerous tissue cross-reactivity studies.
Tissue Cross-Reactivity

Reasons to choose HSRL for all your tissue cross-reactivity needs:

Experience Taking a molecule designed for therapeutic use and applying it to a method such as immunohistochemistry, for which it was not designed, takes thoughtfulness in both the design of the immunohistochemical method that will be used, and in the interpretation of that immunohistochemical method for potential expected and unexpected tissue cross-reactivity.

Tissue Cross-Reactivity

Quality and professional reliability HSRL is committed to quality work, and this applies equally to tissue cross-reactivity studies, with our thoughtful approach to design and interpretation.  With a tissue bank of high quality frozen tissues from human and from species of animals used for preclinical toxicity, HSRL offers the ability to design tissue cross-reactivity studies according to your needs.  We have a wide variety of techniques in our immunohistochemistry toolbox that we can use to design a study that meets the needs of your molecule and program. 

FDA, OECD and MHLW compliance All work is conducted with attention to the GLPs and can be performed under FDA, OECD and MHLW compliance. Each method is validated as needed.

Prompt turnaround As with all of our other work, HSRL prides itself on meeting deadlines and paying close attention to the prompt turnaround often needed by its clients. 

Affordable pricing This speaks for itself. We will be happy to generate a quote after discussing your individual needs and timelines.

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