Pub Date : 2021-12-01DOI: 10.1186/s41120-021-00045-y
M. Patterson, L. A. Beausang, B. Rup, R. Bowsher, K. Krug, M. Melhem, Sharon M. Lu
{"title":"A bridging assay for detection and characterization of anti-drug antibodies to dostarlimab, a new anti-PD-1 therapeutic monoclonal antibody","authors":"M. Patterson, L. A. Beausang, B. Rup, R. Bowsher, K. Krug, M. Melhem, Sharon M. Lu","doi":"10.1186/s41120-021-00045-y","DOIUrl":"https://doi.org/10.1186/s41120-021-00045-y","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79355758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-01DOI: 10.1186/s41120-021-00044-z
D. Nelson, G. D. Marbury
{"title":"A risk-based approach to validation of ion chromatography methods using suppressed conductivity","authors":"D. Nelson, G. D. Marbury","doi":"10.1186/s41120-021-00044-z","DOIUrl":"https://doi.org/10.1186/s41120-021-00044-z","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78382322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-01DOI: 10.1186/s41120-021-00047-w
Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José C. Menezes, Cássio Yooiti Yamakawa
{"title":"An industrial case study: QbD to accelerate time-to-market of a drug product","authors":"Madalena Testas, Tiago da Cunha Sais, Leonardo Piccoli Medinilha, Katia Nami Ito Niwa, Lucas Sponton de Carvalho, Silvia Duarte Maia, Anderson Flores, Lígia Pedroso Braz, José C. Menezes, Cássio Yooiti Yamakawa","doi":"10.1186/s41120-021-00047-w","DOIUrl":"https://doi.org/10.1186/s41120-021-00047-w","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78877904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-12-01DOI: 10.1186/s41120-021-00041-2
Harsh S. Shah, Ankit Gotecha, D. Jetha, Amarjitsing Rajput, A. Bariya, S. Panchal, Shital B Butani
{"title":"Gamma oryzanol niosomal gel for skin cancer: formulation and optimization using quality by design (QbD) approach","authors":"Harsh S. Shah, Ankit Gotecha, D. Jetha, Amarjitsing Rajput, A. Bariya, S. Panchal, Shital B Butani","doi":"10.1186/s41120-021-00041-2","DOIUrl":"https://doi.org/10.1186/s41120-021-00041-2","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90266105","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.1186/s41120-021-00040-3
Martin R. Edelmann, C. Husser, Martina B. Duschmalé, G. Fischer, C. Senn, Erich Koller, A. Brink
{"title":"Tritium labeling of antisense oligonucleotides via different conjugation agents","authors":"Martin R. Edelmann, C. Husser, Martina B. Duschmalé, G. Fischer, C. Senn, Erich Koller, A. Brink","doi":"10.1186/s41120-021-00040-3","DOIUrl":"https://doi.org/10.1186/s41120-021-00040-3","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78250589","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-15DOI: 10.1186/s41120-021-00043-0
Harsh Shah
{"title":"AAPS open social media strategy (2021–2025)","authors":"Harsh Shah","doi":"10.1186/s41120-021-00043-0","DOIUrl":"https://doi.org/10.1186/s41120-021-00043-0","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79357992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-11-11DOI: 10.1186/s41120-021-00039-w
X. Zhang, Hong Chen, Weiping Shao, Z. Lin, M. Melhem, Sharon M. Lu
{"title":"A competitive ligand-binding assay for the detection of neutralizing antibodies against dostarlimab (TSR-042)","authors":"X. Zhang, Hong Chen, Weiping Shao, Z. Lin, M. Melhem, Sharon M. Lu","doi":"10.1186/s41120-021-00039-w","DOIUrl":"https://doi.org/10.1186/s41120-021-00039-w","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78156217","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-09-01DOI: 10.1101/2021.09.01.458024
Jakob C. Stüber, K. Rechberger, S. Miladinović, Thomas Pöschinger, Tamara Zimmermann, Remi Villenave, Miro J. Eigenmann, Thomas E. Kraft, D. Shah, H. Kettenberger, W. Richter
This study explores the impact of antibody surface charge on tissue distribution into various tissues including tumor. Tumor-bearing mice were dosed intravenously with a mixture comprising three antibodies engineered to carry negative charge patches, a balanced charge distribution, or positive patches, respectively (cassette dosing). Tissue levels were analyzed with a specific LC-MS/MS method. In addition, the antibody mix was administered to non-tumor bearing mice. Muscle and skin interstitial fluid were obtained by centrifugation and analyzed by LC-MS/MS. An in vitro endothelium model was explored for its feasibility to mimic the observed distribution differences. A balanced charge distribution was optimal in terms of total tumor exposure, while in other tissues, negatively charged and balanced charged antibodies gave similar results. In contrast, positive charge patches generally resulted in increased serum clearance but markedly enhanced tumor and organ uptake, leading to higher tissue-to-serum ratios. The uptake and availability in the interstitial space were confirmed by specific assessment of antibody levels in the interstitial fluid of the muscle and skin, with similar charge impact as in total tissue. The in vitro model was able to differentiate the transport propensity of this series of antibody variants. In summary, our results show the differential effects of charge patches on an antibody surface on biodistribution and tumor uptake. These insights may help in the design of molecules with biodistribution properties tailored to their purpose, and an optimized safety profile.
{"title":"Impact of charge patches on tumor disposition and biodistribution of therapeutic antibodies","authors":"Jakob C. Stüber, K. Rechberger, S. Miladinović, Thomas Pöschinger, Tamara Zimmermann, Remi Villenave, Miro J. Eigenmann, Thomas E. Kraft, D. Shah, H. Kettenberger, W. Richter","doi":"10.1101/2021.09.01.458024","DOIUrl":"https://doi.org/10.1101/2021.09.01.458024","url":null,"abstract":"This study explores the impact of antibody surface charge on tissue distribution into various tissues including tumor. Tumor-bearing mice were dosed intravenously with a mixture comprising three antibodies engineered to carry negative charge patches, a balanced charge distribution, or positive patches, respectively (cassette dosing). Tissue levels were analyzed with a specific LC-MS/MS method. In addition, the antibody mix was administered to non-tumor bearing mice. Muscle and skin interstitial fluid were obtained by centrifugation and analyzed by LC-MS/MS. An in vitro endothelium model was explored for its feasibility to mimic the observed distribution differences. A balanced charge distribution was optimal in terms of total tumor exposure, while in other tissues, negatively charged and balanced charged antibodies gave similar results. In contrast, positive charge patches generally resulted in increased serum clearance but markedly enhanced tumor and organ uptake, leading to higher tissue-to-serum ratios. The uptake and availability in the interstitial space were confirmed by specific assessment of antibody levels in the interstitial fluid of the muscle and skin, with similar charge impact as in total tissue. The in vitro model was able to differentiate the transport propensity of this series of antibody variants. In summary, our results show the differential effects of charge patches on an antibody surface on biodistribution and tumor uptake. These insights may help in the design of molecules with biodistribution properties tailored to their purpose, and an optimized safety profile.","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78433646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2021-09-01DOI: 10.1186/s41120-021-00037-y
Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser
{"title":"Perspectives in modeling and model validation during analytical quality by design chromatographic method evaluation: a case study","authors":"Yongzhi Dong, Zhimin Liu, Charles Li, Emily Pinter, Alan Potts, Tanya Tadey, William Weiser","doi":"10.1186/s41120-021-00037-y","DOIUrl":"https://doi.org/10.1186/s41120-021-00037-y","url":null,"abstract":"","PeriodicalId":453,"journal":{"name":"AAPS Open","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2021-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87117167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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