Authors:J May, A Del Grosso, N Etz, R Wheeler, and L Rey
(TG), thermogravimetry/mass spectrometry (TG/MS), and loss-on-drying methodology
are used to provide residual moisture results for freeze-dried biological
products regulated by the US Food and Drug Administration. Residual moisture
specifications must be met in order to ensure freeze-dried biological product
potency and stability throughout the licensed product's shelf life.
TG, TG/MS, loss-on-drying and vapor pressure moisture measurements are compared
for a BCG Vaccine. Comparisons are made between residual moisture data for
the freeze-dried cake and vapor pressure moisture determinations in the space
above the freeze-dried cake in the final container. Vapor pressure moisture
precision data is presented for α-interferon and BCG vaccine. Impact
of residual moisture and vapor pressure moisture upon product stability is
Authors:Joana Korablioviene, Mykolas Mauricas, Irena Dumalakiene, Saulius Caplinskas, Rita Viliene, Justinas Baleisis, Gintautas Vysniauskis, Joanna Chorostowska-Wynimko, Ginreta Magelinskiene, Pavel Korabliov, and Arunas Valiulis
]. However, the BCGvaccine is not fully effective due to different BCG strains, the prevalence of environmental mycobacteria, differing host genetics, nutritional factors, and the presence of co-infections such as helminths [ 3 ]. Further, there are two
Authors:Sezer Okay, Rukiye Çetin, Fatih Karabulut, Cennet Doğan, Süheyla Sürücüoğlu, and Aslıhan Kurt Kızıldoğan
. bovis BCG strain expressing the 30-kDa major secretory protein of MTB in the guinea pig model, and obtained better protection than the commercial BCGvaccine. The complementation of BCG strain with ESAT-6 protein from MTB also increased the protection
Authors:Natalya V. Permyakova, Pavel A. Belavin, Dariya S. Pirozhkova, Elena G. Ufimtseva, Sergey M. Rozov, Sergey R. Mursalimov, Yuriy V. Sidorchuk, Elena A. Uvarova, Alla A. Zagorskaya, Tatiana V. Marenkova, Svetlana V. Bannikova, Evgeniy A. Demidov, Konstantin V. Starostin, Marionella A. Kravchenko, Diana V. Vakhrusheva, Roman B. Berdnikov, Natalya I. Eremeeva, Sergey N. Skornyakov, Sergey E. Peltek, and Elena V. Deineko
Kaufmann , S. H. E.
: Tuberculosis vaccines: Time to think about the
Authors:J. May, A. Del Grosso, R. Wheeler, and N. Etz
A TA Instruments Thermal Analysis System (TG) has been interfaced to the Hewlett Packard 5972 quadrupole mass spectrometer.
An OSS-2 variable outlet splitter was plumbed between the TG and the mass spectrometer. This interface allows continuous monitoring
of the ion intensities of mass peaksm/e=18 (water) andm/e=44 (carbon dioxide) used to elucidate the TG transitions attributable to residual moisture in freeze-dried biological products.
Moisture specifications must be met in order to insure product stability throughout the approved shelf life. TG/MS results
are discussed for BCG Vaccine, BCG Live (Intravesical) and U. S. Standard Antihemophilic Factor. Karl Fischer and TG/MS moisture
results are compared.
Authors:Olexandr Smiyan, Mykola Lyndin, Oksana Romaniuk, Vladyslav Sikora, Artem Piddubnyi, Alla Yurchenko, Anna Korobchanska, Iryna Tarasova, Natalia Hyryavenko, Kateryna Sikora, and Anatolii Romaniuk
, poliomyelitis, etc.) in the first days of life and requires monitoring of the immunological status of children [ 17 – 19 ]. Consequently, in case of immunodeficiency, the BCGvaccine strain becomes “paradoxic agent” of opportunistic infection, despite the high