Application of recovery tests in the validation of immunoassays for assessing the immunogenicity of B. anthracis PA vaccine

PDA Journal of Pharmaceutical Science and Technology

Volumn 55, Issue 3, 2001, Pages 150-161

  Halperin, G ^a   Marcus, H ^a  

^a Dept of Biotechnology ^*  (Israel)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIGEN; NEUTRALIZING ANTIBODY; VACCINE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANTIBODY PRODUCTION; ANTIBODY TITER; ARTICLE; BACILLUS ANTHRACIS; CALIBRATION; CONTROLLED STUDY; ENZYME LINKED IMMUNOSORBENT ASSAY; GUINEA PIG; IMMUNOASSAY; IMMUNOGENICITY; NONHUMAN; REGRESSION ANALYSIS; VACCINATION;

ANIMALS; ANTHRAX VACCINES; ANTIBODIES, BACTERIAL; ENZYME-LINKED IMMUNOSORBENT ASSAY; GUINEA PIGS; REGRESSION ANALYSIS; REPRODUCIBILITY OF RESULTS;

EID: 0034991265     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (9)

1. Current good manufacturing practice for finished pharmaceuticals
2. Guidance for industry: Bioanalytical methods validation for human studies
3. Macrophages are sensitive to anthrax lethal toxin through an acid-dependent process
4. Calcium is required for the expression of anthrax lethal toxin activity in macrophagelike cell line J774A.1
5. Production and characterization of monoclonal antibodies against the lethal factor component of bacillus anthracis lethal toxin
6. Comparative efficacy of experimental anthrax vaccine candidates against inhalation anthrax in rhesus macaques