Abstract
The therapeutic use of monoclonal antibodies offers virtually unlimited possibilities in situations in which currently available treatments are ineffective. Yet, with this promise come new special public health concerns. The introduction into humans of materials produced by an immortal, often xenogeneic, cell line produced in tissue culture or mouse ascites, which potentially reacts with components of human tissues, carries risks that at times may be hard to define. The Office of Biologics Research and Review has attempted to compile a list of problems, side effects, toxicities, and untoward reactions of which investigators and clinicians should be cognizant.
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Keywords
- Murine Leukemia Virus
- Monoclonal Antibody Product
- Lymphocytic Choriomeningitis Virus
- Tissue Culture Supernatant
- Xenotropic Murine Leukemia
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
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Hoffman, T. (1987). Regulatory Issues Surrounding Therapeutic Use of Monoclonal Antibodies. In: Bartal, A.H., Hirshaut, Y. (eds) Methods of Hybridoma Formation. Contemporary Biomedicine, vol 7. Humana Press. https://doi.org/10.1007/978-1-4612-4826-2_25
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DOI: https://doi.org/10.1007/978-1-4612-4826-2_25
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