The quantitative immunochemical determination of pneumococcal and meningococcal capsular polysaccharides by light scattering rate nephelometry |
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| Authors: | C J Lee |
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| Institution: | 2. Bureau of Biologics, Food and Drug Administration, 8800 Rockville Pike, Bethesda, Maryland 20205, U.S.A.;1. Laboratorio de Recursos Forestales, CADIC-CONICET, Houssay 200 (9410) Ushuaia, Tierra del Fuego, Argentina;2. INTA-UNPA-CONICET, CC 332 (9400) Río Gallegos, Santa Cruz, Argentina;1. Laboratory of Clinical and Behavioural Neurology, IRCCS Santa Lucia Foundation, Rome, Italy;2. NESMOS Department, Faculty of Medicine and Psychology, “Sapienza” University of Rome, Rome, Italy;3. Department of Neurology and Psychiatry, Faculty of Medicine, “Sapienza” University of Rome, Rome, Italy;4. Department of Neuroscience, “Tor Vergata” University, Rome, Italy;5. Department of Psychiatry and Behavioral Science, University of Nevada School of Medicine, Reno, NV, USA;1. Department of Anatomy and Experimental Morphology and Core Facility Small Animal Irradiation, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;2. Department for Radiation Oncology, Ambulatory Center, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;3. Department of Stem Cell Transplantation, Research Department Cell and Gene Therapy, University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany |
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| Abstract: | A quantitative nephelometric method was used for the measurement of the individual pneumococcal, as well as meningococcal, polysaccharides in the polyvalent vaccine final containers. This method is simple, rapid, inexpensive, and provides both qualitative and quantitative analyses of the polyvalent polysaccharide vaccines. By this method the individual pneumococcal types, 1, 2, 3, 4, 6A, 7F, 8, 9N, 12F, 14, 18C, 19F, 23F and 25 polysaccharides, were found to be present at 90-114% of the manufacturer's indicated concentrations; meningococcal group A, C, Y and W135 polysaccharides were at 90-108% of the manufacturer's listed concentrations. This nephelometric method coupled with gel filtration can also be used for measurement of the molecular sizes or stability of individual polysaccharides in the final container. Pneumococcal polysaccharide types 3, 6A, 9N and 19F, used as representative types, were treated with 0.5 N hydrochloric acid. The molecular sizes for types 3 and 9 N polysaccharides were stable to acid treatment. In contrast, types 6A and 19F polysaccharides were degraded. Heating meningococcal groups A, C, Y and W135 polysaccharides at 37 degrees C for 48 h did not affect their molecular size in the polyvalent vaccine. |
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