The study of cross-reactivity of therapeutic drugs based on monoclonal antibodies on human tissues: basic approaches and methodological techniques
Abstract
Tissue cross-reactivity (TCR) studies are screening immunohistochemical (IHC) assays, usually conducted on frozen human and animal tissues. This study is obligatory for getting the permission for clinical trials in Russia for all innovative therapeutic products based on monoclonal antibodies or antibody-like molecules that contain complementarity-determining region (CDR). In this article are represented approaches and methodical features for successful conduction of tissue cross-reactivity studies with examples from own authors’ experience.
About the Authors
T. Y. Ostroukhova
CJSC «BIOCAD»
Russian Federation
Head of the laboratory of immunological methods of the Preclinical Studies Department. Candidate of Biological Sciences
Russian Federation
Head of the laboratory of immunological methods of the Preclinical Studies Department. Candidate of Biological Sciences
V. A. Ivanov
CJSC «BIOCAD»
Russian Federation
Research associate of the Preclinical Studies Department
Russian Federation
Research associate of the Preclinical Studies Department
E. L. Morozova
CJSC «BIOCAD»
Russian Federation
Head of the Department of preclinical trials of drug products
Russian Federation
Head of the Department of preclinical trials of drug products
R. A. Ivanov
CJSC «BIOCAD»
Russian Federation
Russian Federation
References
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Review
For citations:
Ostroukhova T.Y., Ivanov V.A., Morozova E.L., Ivanov R.A. The study of cross-reactivity of therapeutic drugs based on monoclonal antibodies on human tissues: basic approaches and methodological techniques. BIOpreparations. Prevention, Diagnosis, Treatment. 2016;16(4):237-244. (In Russ.)
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