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17 results on '"Goerke, Aaron"'

4. Development of a Novel Vaccine Containing Binary Toxin for the Prevention of Clostridium difficile Disease with Enhanced Efficacy against NAP1 Strains

Author

Secore, Susan, primary, Wang, Su, additional, Doughtry, Julie, additional, Xie, Jinfu, additional, Miezeiewski, Matt, additional, Rustandi, Richard R., additional, Horton, Melanie, additional, Xoconostle, Rachel, additional, Wang, Bei, additional, Lancaster, Catherine, additional, Kristopeit, Adam, additional, Wang, Sheng-Ching, additional, Christanti, Sianny, additional, Vitelli, Salvatore, additional, Gentile, Marie-Pierre, additional, Goerke, Aaron, additional, Skinner, Julie, additional, Strable, Erica, additional, Thiriot, David S., additional, Bodmer, Jean-Luc, additional, and Heinrichs, Jon H., additional

Published
2017
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6. Development and Optimization of a High-Throughput Assay To Measure Neutralizing Antibodies against Clostridium difficile Binary Toxin

Author

Xie, Jinfu, primary, Horton, Melanie, additional, Zorman, Julie, additional, Antonello, Joseph M., additional, Zhang, Yuhua, additional, Arnold, Beth A., additional, Secore, Susan, additional, Xoconostle, Rachel, additional, Miezeiewski, Matthew, additional, Wang, Su, additional, Price, Colleen E., additional, Thiriot, David, additional, Goerke, Aaron, additional, Gentile, Marie-Pierre, additional, Skinner, Julie M., additional, and Heinrichs, Jon H., additional

Published
2014
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15. Cell-free synthesis of proteins that require disulfide bonds using glucose as an energy source.

Author

Knapp, Kurtis G., Goerke, Aaron R., and Swartz, James R.

Subjects
PROTEIN synthesis, GLUCOSE, RECOMBINANT proteins, MICROBIOLOGICAL synthesis, RECOMBINANT molecules
Abstract

The article discusses a study which created a cell-free protein synthesis extract which produces disulfide-bond requiring proteins and having glucose as energy source. It is noted that cell-free synthesis (CFPS) can be used to replace bacterial fermentation in the production of recombinant proteins. The study concluded that the CFPS reactions with KGK10 extracts produce UK and mGM-CSF proteins which require disulfide bonds.

Published
2007
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16. Development and Optimization of a High-Throughput Assay To Measure Neutralizing Antibodies against Clostridium difficileBinary Toxin

Author

Xie, Jinfu, Horton, Melanie, Zorman, Julie, Antonello, Joseph M., Zhang, Yuhua, Arnold, Beth A., Secore, Susan, Xoconostle, Rachel, Miezeiewski, Matthew, Wang, Su, Price, Colleen E., Thiriot, David, Goerke, Aaron, Gentile, Marie-Pierre, Skinner, Julie M., and Heinrichs, Jon H.

Abstract

ABSTRACTClostridium difficilestrains producing binary toxin, in addition to toxin A (TcdA) and toxin B (TcdB), have been associated with more severe disease and increased recurrence of C. difficileinfection in recent outbreaks. Binary toxin comprises two subunits (CDTa and CDTb) and catalyzes the ADP-ribosylation of globular actin (G-actin), which leads to the depolymerization of filamentous actin (F-actin) filaments. A robust assay is highly desirable for detecting the cytotoxic effect of the toxin and the presence of neutralizing antibodies in animal and human sera to evaluate vaccine efficacy. We describe here the optimization, using design-of-experiment (DOE) methodology, of a high-throughput assay to measure the toxin potency and neutralizing antibodies (NAb) against binary toxin. Vero cells were chosen from a panel of cells screened for sensitivity and specificity. We have successfully optimized the CDTa-to-CDTb molar ratio, toxin concentration, cell-seeding density, and sera-toxin preincubation time in the NAb assay using DOE methodology. This assay is robust, produces linear results across serial dilutions of hyperimmune serum, and can be used to quantify neutralizing antibodies in sera from hamsters and monkeys immunized with C. difficilebinary toxin-containing vaccines. The assay will be useful for C. difficilediagnosis, for epidemiology studies, and for selecting and optimizing vaccine candidates.

Published
2014
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17. A Risk Index and Data Display for Process Performance in the Pharmaceutical Industry.

Author

Gunter B, Coleman D, Goerke A, Koulis T, Lamerz J, and Peng Y

Subjects
Drug Compounding, Drug Industry methods, Models, Statistical, Quality Control, Risk Management, Technology, Pharmaceutical methods, Workflow, Data Display standards, Drug Industry standards, Pharmaceutical Preparations standards, Technology, Pharmaceutical standards
Abstract

We propose a new index and graphical display for quantifying and visualizing process performance in the pharmaceutical industry. These tools can provide management a comprehensive, high level overview of the process performance of a global manufacturing network suitable for risk ranking, by which is meant: identifying those processes at greatest risk of failing to meet specifications, and prioritizing resources to drive continuous process improvement. Our index, like others currently in use, compares the observed variation of CQAs-critical quality attributes-to their specifications. However, instead of relying on traditional data summaries such as means and standard deviations to characterize process results, the proposed index uses sample quantiles. Quantiles are more accurate and reliable when data are skewed or short-tailed as is often observed for pharmaceutical processes. Perhaps just as important, we communicate the results with a new visual display that accurately compares processes and sites. The display identifies instances when the summaries may mislead and the subject matter expert needs to "drill down" into manufacturing data to assure correct understanding. LAY ABSTRACT: The proposed risk index and graphical display enables high-risk processes to be identified, process improvements to be prioritized, resources to be efficiently allocated, and strategic planning for continuous process improvement to be evidence-based., (© PDA, Inc. 2018.)

Published
2018
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