The Experts below are selected from a list of 306 Experts worldwide ranked by ideXlab platform
Yijia Jiang - One of the best experts on this subject based on the ideXlab platform.
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root cause analysis of Tungsten induced protein aggregation in pre filled syringes
Pda Journal of Pharmaceutical Science and Technology, 2010Co-Authors: Wei Liu, Yasser Nashedsamuel, Yijia Jiang, Zaiqing Wen, Rob Swift, Gianni Torraca, Aylin Vance, Anthony Miresluis, Erwin Freund, Janice M DavisAbstract:Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and Tungsten. The origin of the Tungsten was traced to the Tungsten pins used in the supplier9s syringe barrel forming process. A Tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of Tungsten in solutions. The air gap formed in the syringe funnel area (rich in residual Tungsten) becomes accessible to solutions when the vacuum is pulled. Leachable Tungsten deposits that were not removed by the supplier9s wash process are concentrated in this small area. Extraction procedures used to measure residual Tungsten in empty syringes would under-report the Tungsten quantity unless the funnel area is wetted during the extraction. Improved syringe barrel forming and washing processes at the supplier have lowered the residual Tungsten content and significantly reduced the risk of protein aggregate formation. This experience demonstrates that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality. Thus close technical communication with suppliers of product contact components plays an important role in making a successful biotherapeutic.
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Tungsten induced protein aggregation solution behavior
Journal of Pharmaceutical Sciences, 2009Co-Authors: Yijia Jiang, Yasser Nashedsamuel, Kiyoshi Fujimori, Monica Pallitto, Lisa Donahue, Wei Liu, Joey Pollastrini, David Mallard, Zaiqing Wen, Grace C ChuAbstract:Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, Tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with Tungsten species obtained from the extraction of Tungsten pins typically used in syringe manufacturing processes. These results were compared to those obtained with various soluble Tungsten species from commercial sources. Although visible protein particles and aggregates were induced by Tungsten from both sources, the extract from Tungsten pins was more effective at inducing the formation of the soluble protein aggregates than the Tungsten from other sources. Furthermore, our studies showed that the effect of Tungsten on protein aggregation is dependent on the pH of the buffer used, the Tungsten species, and the Tungsten concentration present. The lower pH and increased Tungsten concentration induced more protein aggregation. The protein molecules in the Tungsten-induced aggregates had mostly nativelike structure, and aggregation was at least partly reversible. The aggregation was dependent on Tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and Tungsten molecules. The level of Tungsten required from the various sources was different, but in all cases it was at least an order of magnitude greater than the typical soluble Tungsten levels measured in commercial PFS. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4695–4710, 2009
Grace C Chu - One of the best experts on this subject based on the ideXlab platform.
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Tungsten induced protein aggregation solution behavior
Journal of Pharmaceutical Sciences, 2009Co-Authors: Yijia Jiang, Yasser Nashedsamuel, Kiyoshi Fujimori, Monica Pallitto, Lisa Donahue, Wei Liu, Joey Pollastrini, David Mallard, Zaiqing Wen, Grace C ChuAbstract:Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, Tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with Tungsten species obtained from the extraction of Tungsten pins typically used in syringe manufacturing processes. These results were compared to those obtained with various soluble Tungsten species from commercial sources. Although visible protein particles and aggregates were induced by Tungsten from both sources, the extract from Tungsten pins was more effective at inducing the formation of the soluble protein aggregates than the Tungsten from other sources. Furthermore, our studies showed that the effect of Tungsten on protein aggregation is dependent on the pH of the buffer used, the Tungsten species, and the Tungsten concentration present. The lower pH and increased Tungsten concentration induced more protein aggregation. The protein molecules in the Tungsten-induced aggregates had mostly nativelike structure, and aggregation was at least partly reversible. The aggregation was dependent on Tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and Tungsten molecules. The level of Tungsten required from the various sources was different, but in all cases it was at least an order of magnitude greater than the typical soluble Tungsten levels measured in commercial PFS. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4695–4710, 2009
Wei Liu - One of the best experts on this subject based on the ideXlab platform.
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root cause analysis of Tungsten induced protein aggregation in pre filled syringes
Pda Journal of Pharmaceutical Science and Technology, 2010Co-Authors: Wei Liu, Yasser Nashedsamuel, Yijia Jiang, Zaiqing Wen, Rob Swift, Gianni Torraca, Aylin Vance, Anthony Miresluis, Erwin Freund, Janice M DavisAbstract:Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and Tungsten. The origin of the Tungsten was traced to the Tungsten pins used in the supplier9s syringe barrel forming process. A Tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of Tungsten in solutions. The air gap formed in the syringe funnel area (rich in residual Tungsten) becomes accessible to solutions when the vacuum is pulled. Leachable Tungsten deposits that were not removed by the supplier9s wash process are concentrated in this small area. Extraction procedures used to measure residual Tungsten in empty syringes would under-report the Tungsten quantity unless the funnel area is wetted during the extraction. Improved syringe barrel forming and washing processes at the supplier have lowered the residual Tungsten content and significantly reduced the risk of protein aggregate formation. This experience demonstrates that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality. Thus close technical communication with suppliers of product contact components plays an important role in making a successful biotherapeutic.
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Tungsten induced protein aggregation solution behavior
Journal of Pharmaceutical Sciences, 2009Co-Authors: Yijia Jiang, Yasser Nashedsamuel, Kiyoshi Fujimori, Monica Pallitto, Lisa Donahue, Wei Liu, Joey Pollastrini, David Mallard, Zaiqing Wen, Grace C ChuAbstract:Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, Tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with Tungsten species obtained from the extraction of Tungsten pins typically used in syringe manufacturing processes. These results were compared to those obtained with various soluble Tungsten species from commercial sources. Although visible protein particles and aggregates were induced by Tungsten from both sources, the extract from Tungsten pins was more effective at inducing the formation of the soluble protein aggregates than the Tungsten from other sources. Furthermore, our studies showed that the effect of Tungsten on protein aggregation is dependent on the pH of the buffer used, the Tungsten species, and the Tungsten concentration present. The lower pH and increased Tungsten concentration induced more protein aggregation. The protein molecules in the Tungsten-induced aggregates had mostly nativelike structure, and aggregation was at least partly reversible. The aggregation was dependent on Tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and Tungsten molecules. The level of Tungsten required from the various sources was different, but in all cases it was at least an order of magnitude greater than the typical soluble Tungsten levels measured in commercial PFS. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4695–4710, 2009
Chen Junling - One of the best experts on this subject based on the ideXlab platform.
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property comparison of vacuum and air plasma sprayed Tungsten coatings
Journal of Alloys and Compounds, 2021Co-Authors: Chong Fali, Chen JunlingAbstract:Abstract Plasma spraying technology was employed to fabricate the Tungsten coating as plasma facing material on copper alloy. And the property comparison was carried out on the vacuum sprayed Tungsten coating and the air sprayed Tungsten coating. The results indicated that compared to the air plasma sprayed Tungsten coating, vacuum plasma sprayed Tungsten coating has lower porosity, lower impurity content, better transport heat capability, and better bonding strength. Therefore, vacuum plasma sprayed Tungsten coating is fitter for plasma facing material in fusion device.
Zaiqing Wen - One of the best experts on this subject based on the ideXlab platform.
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root cause analysis of Tungsten induced protein aggregation in pre filled syringes
Pda Journal of Pharmaceutical Science and Technology, 2010Co-Authors: Wei Liu, Yasser Nashedsamuel, Yijia Jiang, Zaiqing Wen, Rob Swift, Gianni Torraca, Aylin Vance, Anthony Miresluis, Erwin Freund, Janice M DavisAbstract:Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and Tungsten. The origin of the Tungsten was traced to the Tungsten pins used in the supplier9s syringe barrel forming process. A Tungsten recovery study showed that the vacuum stopper placement process has a significant impact on the total amount of Tungsten in solutions. The air gap formed in the syringe funnel area (rich in residual Tungsten) becomes accessible to solutions when the vacuum is pulled. Leachable Tungsten deposits that were not removed by the supplier9s wash process are concentrated in this small area. Extraction procedures used to measure residual Tungsten in empty syringes would under-report the Tungsten quantity unless the funnel area is wetted during the extraction. Improved syringe barrel forming and washing processes at the supplier have lowered the residual Tungsten content and significantly reduced the risk of protein aggregate formation. This experience demonstrates that packaging component manufacturing processes, which are outside the direct control of drug manufacturers, can have an impact on the drug product quality. Thus close technical communication with suppliers of product contact components plays an important role in making a successful biotherapeutic.
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Tungsten induced protein aggregation solution behavior
Journal of Pharmaceutical Sciences, 2009Co-Authors: Yijia Jiang, Yasser Nashedsamuel, Kiyoshi Fujimori, Monica Pallitto, Lisa Donahue, Wei Liu, Joey Pollastrini, David Mallard, Zaiqing Wen, Grace C ChuAbstract:Tungsten has been associated with protein aggregation in prefilled syringes (PFSs). This study probed the relationship between PFSs, Tungsten, visible particles, and protein aggregates. Experiments were carried out spiking solutions of two different model proteins with Tungsten species obtained from the extraction of Tungsten pins typically used in syringe manufacturing processes. These results were compared to those obtained with various soluble Tungsten species from commercial sources. Although visible protein particles and aggregates were induced by Tungsten from both sources, the extract from Tungsten pins was more effective at inducing the formation of the soluble protein aggregates than the Tungsten from other sources. Furthermore, our studies showed that the effect of Tungsten on protein aggregation is dependent on the pH of the buffer used, the Tungsten species, and the Tungsten concentration present. The lower pH and increased Tungsten concentration induced more protein aggregation. The protein molecules in the Tungsten-induced aggregates had mostly nativelike structure, and aggregation was at least partly reversible. The aggregation was dependent on Tungsten and protein concentration, and the ratio of these two and appears to arise through electrostatic interaction between protein and Tungsten molecules. The level of Tungsten required from the various sources was different, but in all cases it was at least an order of magnitude greater than the typical soluble Tungsten levels measured in commercial PFS. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 98:4695–4710, 2009
