Process economical effects of implementation of ready-to-use micro carriers in cell- based virus vaccine production

Micro-carriers are used as support for the growth of adherent cells. By providing a large cultivation surface in bioreactor cultures, micro-carriers have replaced, to a great extent, cultivation in Cell Factory™ systems or roller bottles over the last decades. At Sanofi Pasteur, one of the world leaders in human vaccines, Cytodex™ 1 microcarriers have been used in the production of viral vaccines on Vero cells for several years. In accordance with the supplier’s recommendation, the microcarriers that are delivered dry are swollen in buffer, washed, and heat-sterilized before use. Since October 2016 a ready-to-use Cytodex™ 1 alternative, delivered presterilized by gamma irradiation, is available. Before implementing the change, the presterilized alternative was first evaluated with regards to reduced preparation time and cost. With a two-year shelf-life, the presterilized alternative reduced utility cost and added flexibility to operations by decreasing the need for steam and stainless steel materials in viral production facilities, and in alignment with extended use of single-use bioreactors equipment. The second step was to compare the cell growth and viral productivity using this ready-to-use alternative with that of the prior referenced product in place. Both cell growth and viral productivity were comparable between the two products, which supported further the documentation for the implementation of this ready-to-use alternative in GMP manufacturing for new R&D vaccine projects. The qualification process covered technical, quality, and analytical aspects based on the supplier documentation, and internal analyses and justification regarding our requirements in upstream vaccine production. While the presterilized Cytodex™ 1 microcarriers are now implemented in process development for new vaccines and qualified for manufacturing of clinical batches of new vaccine products, the next step will be to evaluate the benefits and impacts of replacing the microcarrier reference product with the gamma sterilized alternative on industrial products

Graduation Rates of Career and Technical Education (CTE) Concentrators in Kentucky: A Comparative Study

This research was driven by the desire to determine if graduation rates of high school students in Kentucky are significantly affected when they decide to concentrate on a Career and Technical Education (CTE) career pathway. To clarify, the research questions that prompted this study seek to find out if 12th grade CTE concentrator students in programs of study at (16) randomly chosen Area Technology Centers (ATCs) across the state had different graduation rates than those 12th grade students not engaged in CTE career pathways in (16) corresponding high schools for the 2012 – 2013 school year. The study also compared the graduation rates of CTE concentrators from the 53 state operated ATCs to the graduation rates of the 12th grade general academic students in all public school districts in Kentucky for the 2012 – 2013 school year. The study utilized a quantitative approach and an independent samples t-test with SPSS software to examine data to determining if there was a significant difference in the graduation rates of the two groups of students. A p \u3c .05 level of significance was used for all analyses in the study to determine if the null hypotheses could be rejected

Gendered Feelings About Our National Issue(s)

This paper was presented as a keynote address to the Canadian Women's Studies Association in a SSHRCC sponsored session entitled "Resisting the Neo-Conservative Agenda Globally and Locally: Economy, Representation and Feminist Praxis." The author speaks as a Quebec feminist as she argues for serious feminist participation in the political restructuring of Canada

Treatment of adult-onset Still's disease: a review

Adult-onset Still's disease (AOSD) is a rare inflammatory disorder that has been recently classified as a polygenic autoinflammatory disorder. The former classification, based on the disease course, seems to be quite dated. Indeed, there is accumulating evidence that AOSD can be divided into two distinct phenotypes based on cytokine profile, clinical presentation, and outcome, ie, a "systemic" pattern and an "articular" pattern. The first part of this review deals with the treatments that are currently available for AOSD. We then present the different strategies based on the characteristics of the disease according to clinical presentation. To do so, we focus on the two subsets of the disease. Finally, we discuss the management of life-threatening complications of AOSD, along with the therapeutic options during pregnancy

Using single quantum states as spin filters to study spin polarization in ferromagnets

By measuring electron tunneling between a ferromagnet and individual energy levels in an aluminum quantum dot, we show how spin-resolved quantum states can be used as filters to determine spin-dependent tunneling rates. We also observe magnetic-field-dependent shifts in the magnet's electrochemical potential relative to the dot's energy levels. The shifts vary between samples and are generally smaller than expected from the magnet's spin-polarized density of states. We suggest that they are affected by field-dependent charge redistribution at the magnetic interface.Comment: 4 pages, 1 color figur

PENGARUH MODEL INKUIRI TERBIMBING TERHADAP KEMAMPUAN METAKOGNITIF DAN KEMANDIRIAN BELAJAR PESERTA DIDIK DI PONDOK PESANTREN AL-FATAH NATAR LAMPUNG SELATAN

ABSTRAK PENGARUH MODEL INKUIRI TERBIMBING TERHADAP KEMAMPUAN METAKOGNITIF DAN KEMANDIRIAN BELAJAR PESERTA DIDIK DI PONDOK PESANTREN AL-FATAH NATAR LAMPUNG SELATAN Oleh: SEVE SINTA SARI Kemampuan metakognitif menekankan pada kemampuan merencanakan, memantau, dan mengevaluasi pemecahan masalah. Berdasarkan studi pendahuluan ini ditemukan bahwa kemampuan metakognitif siswa MA Al-Fatah Natar Lampung Selatan masih sangat rendah. Hal ini mungkin disebabkan oleh model pembelajaran yang tidak tepat. Penelitian ini bertujuan untuk mengetahui (1) Apakah terdapat pengaruh model pembelajaran inkuiri terbimbing terhadap kemampuan metakognitif Peserta didik di kelas XI. (2) Apakah ada pengaruh model pembelajaran inkuiri terbimbing terhadap kemandirian belajar peserta didik dikelas XI. Penelitian ini dilaksanakan di MA Al-Fatah Natar Lampung Selatan tahun ajaran 2020/2021, menggunakan metode eksperimen semu yang menggunakan desain matching pretest-posttest design. Pengambilan sampel dalam penelitian ini menggunakan teknik cluster random sampling. Sampel penelitian ini adalah 26 siswa kelas XI MIPA 1 sebagai kelas eksperimen yaitu kelas yang menggunakan model pembelajaran inkuiri terbimbing, dan 26 siswa kelas XI MIPA 2 sebagai kelas kontrol yaitu kelas yang menggunakan model pembelajaran discovery learning. model. .Uji hipotesis yang digunakan adalah analisis variasi dua jalan sel tak sama. Uji prasyarat dilakukan sebelum melakukan pengujian hipotesis yaitu meliputi uji normalitas dengan menggunakan uji liliefors dan uji homogenitas dengan uji barlett. Hal ini bisa dilihat dari uji hipotesis yang memperoleh nilai Sig. 0,000 yang mana ,sehingga H0 ditolak maka variabel bebas (model inkuiri terbimbing) menunjukkan adanya pengaruh pada variabel terikat (kemampuan metakognitif dan kemandirian belajar). Kata Kunci: Model Inkuiri Terbimbing, Kemampuan Metakognitif dan Kemandirian Belaja