Regulatory Issues Surrounding Therapeutic Use of Monoclonal Antibodies

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.

[1]  T. Merigan,et al.  Rapid detection and quantitation of human cytomegalovirus in urine through DNA hybridization. , 1983, The New England journal of medicine.

[2]  J. Sever.  Application of a microtechnique to viral serological investigations. , 1962, Journal of immunology.

[3]  P. Peebles.  An in vitro focus-induction assay for xenotropic murine leukemia virus, feline leukemia virus C, and the feline--primate viruses RD-114/CCC/M-7. , 1975, Virology.

[4]  J. Parker,et al.  Sensitivity of enzyme-linked immunosorbent assay, complement fixation, and hemagglutination inhibition serological tests for detection of Sendai virus antibody in laboratory mice , 1979, Journal of clinical microbiology.

[5]  J. Hotchin,et al.  Laboratory diagnosis of lymphocytic choriomeningitis. , 1975, Bulletin of the World Health Organization.

[6]  J. Hansen,et al.  Fatal Epstein-Barr-virus-associated proliferation of donor B cells after treatment of acute graft-versus-host disease with a murine anti-T-cell antibody. , 1984, Annals of internal medicine.

[7]  R. J. Harris.  The Problems of Laboratory Animal Disease , 1963 .

[8]  S. Spiegelman,et al.  Purification and detection of reverse transcriptase in viruses and cells. , 1974, Methods in enzymology.

[9]  K. Paigen,et al.  A simple, rapid, and sensitive DNA assay procedure. , 1980, Analytical biochemistry.

[10]  J. Hartley,et al.  Mixed culture cytopathogenicity: a new test for growth of murine leukemia viruses in tissue culture. , 1969, Proceedings of the National Academy of Sciences of the United States of America.

[11]  J. Kapuściński,et al.  Simple and rapid fluorimetric method for DNA microassay. , 1977, Analytical biochemistry.

[12]  T. W. James,et al.  Assay for nanogram quantities of DNA in cellular homogenates. , 1979, Analytical biochemistry.

[13]  J. Hartley,et al.  Genetic study of lymphoma induction by AKR mink cell focus-inducing virus in AKR x NFS crosses , 1981, The Journal of experimental medicine.

[14]  C. V. van Beveren,et al.  Detection and elimination of cellular nucleic acids in biologicals produced on continuous cell lines. , 1981, Developments in biological standardization.

[15]  T. Loomis.  Essentials of Toxicology , 1968 .

[16]  J. Parker,et al.  Murine virus contaminants of leukemia viruses and transplantable tumors. , 1972, Journal of the National Cancer Institute.

[17]  R. Huebner,et al.  POLYOMA AND OTHER INDIGENOUS MOUSE VIRUSES. , 1963, Laboratory animal care.