Výsledky vyhledávání - "Danny K. Chou"

Stress Factors in mAb Drug Substance Production Processes: Critical Assessment of Impact on Product Quality and Control Strategy

Autor: Valentyn Antochshuk, Vasco Filipe, Linda O. Narhi, Tapan K. Das, Alavattam Sreedhara, Tim Menzen, Christoph Grapentin, Danny K. Chou

Publikováno v: Journal of Pharmaceutical Sciences. 109:116-133

The success of biotherapeutic development heavily relies on establishing robust production platforms. During the manufacturing process, the protein is exposed to multiple stress conditions that can result in physical and chemical modifications. The m

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::138b2ace28c629db2fc8d4ca11791e18
https://doi.org/10.1016/j.xphs.2019.09.023

Zobrazit plný text záznamu

Nucleation in protein aggregation in biotherapeutic development

Autor: Tapan K. Das, Danny K. Chou, Wim Jiskoot, Paolo Arosio

Publikováno v: Journal of Pharmaceutical Sciences, 111(4), 951-959

In spite of extensive research, protein aggregation still remains one of the most difficult phenomena to be understood in the field of biologics research and development. Protein aggregation is a complex process which results in the formation of a va

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e881753c1b6e4ca00eabc1623320bbdb
https://hdl.handle.net/1887/3281076

Zobrazit plný text záznamu

Stress factors in primary packaging, transportation and handling of protein drug products and their impact on product quality

Autor: Linda O. Narhi, Danny K. Chou, Twinkle. R. Christian, Scott Gibson, Bharat Jagannathan, Wim Jiskoot, Susan Jordan, Alavattam Sreedhara, Lloyd Waxman, Tapan K. Das

Publikováno v: Journal of Pharmaceutical Sciences, 111(4), 887-902

Protein-based biologic drugs encounter a variety of stress factors during drug substance (DS) and drug product (DP) manufacturing, and the subsequent steps that result in clinical administration by the end user. This article is the third in a series

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c3d52500cdb925a4592e909fd39c998f
https://hdl.handle.net/1887/3281078

Zobrazit plný text záznamu

Emerging Challenges and Innovations in Surfactant-mediated Stabilization of Biologic Formulations

Autor: Joshua S. Katz, Danny K. Chou, Twinkle R. Christian, Tapan K. Das, Mayank Patel, Shubhadra N. Singh, Yi Wen

Publikováno v: Journal of pharmaceutical sciences. 111(4)

Biologics may be subjected to various destabilizing conditions during manufacturing, transportation, storage, and use. Therefore, biologics must be appropriately formulated to meet their desired quality target product profiles. In the formulations of

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a12736898de13ce50743d4a71bd6c237
https://pubmed.ncbi.nlm.nih.gov/34883096

Zobrazit plný text záznamu

Stress factors in protein drug product manufacturing and their impact on product quality

Autor: Twinkle R. Christian, Tapan K. Das, Christoph Grapentin, Alavattam Sreedhara, Danny K. Chou, Vasco Filipe, James A. Searles, James D. Colandene, Wim Jiskoot, Linda O. Narhi

Publikováno v: Journal of Pharmaceutical Sciences

Injectable protein-based medicinal products (drug products, or DPs) must be produced by using sterile manufacturing processes to ensure product safety. In DP manufacturing the protein drug substance, in a suitable final formulation, is combined with

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::bc9d83c3067e2650351eb7d12bccf37f
https://hdl.handle.net/1887/3273879

Zobrazit plný text záznamu

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

Autor: Karoline Bechtold-Peters, Jeffrey T. Blue, Hanns-Christian Mahler, Mary E.M. Cromwell, Michel Awwad, Satish K. Singh, Thomas Spitznagel, Doug P. Nesta, Danny K. Chou, Hans-Juergen Krause, Nataliya Afonina, Brian K. Meyer, Linda O. Narhi

Publikováno v: Journal of Pharmaceutical Sciences. 99:3302-3321

Concern around the lack of monitoring of proteinaceous subvisible particulates in the 0.1-10 microm range has been heightened (Carpenter et al., 2009, J Pharm Sci 98: 1202-1205), primarily due to uncertainty around the potential immunogenicity risk f

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8da6cbebd9afebc1062b8e250b485ee8
https://doi.org/10.1002/jps.22097

Zobrazit plný text záznamu

Stability of Protein Pharmaceuticals: An Update

Autor: Brian Murphy, Robert W. Payne, Derrick S. Katayama, Mark C. Manning, Danny K. Chou

Publikováno v: Pharmaceutical Research. 27:544-575

In 1989, Manning, Patel, and Borchardt wrote a review of protein stability (Manning et al., Pharm. Res. 6:903-918, 1989), which has been widely referenced ever since. At the time, recombinant protein therapy was still in its infancy. This review summ

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fa66c12639944fbc397b06c36daab2fb
https://doi.org/10.1007/s11095-009-0045-6

Zobrazit plný text záznamu

Solution behavior of a novel type 1 interferon, interferon-τ

Autor: Lorelie Villarete, Danny K. Chou, Jackie Campos, Mark C. Manning, Rajiv Nayar, Derrick S. Katayama, Julianne Cooper, Chih-Ping Liu, David Vander Velde

Publikováno v: Journal of Pharmaceutical Sciences. 94:2703-2715

Interferon-tau (IFN-tau) is a novel cytokine that appears during fetal development of mammals. It is currently being investigated for treatment of viral infections and autoimmune diseases. In order to develop a commercial product, a stable formulatio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b9e14ded1f34bef9f79abfe4039a2ad3
https://doi.org/10.1002/jps.20461

Zobrazit plný text záznamu

Effects of solution conditions on methionine oxidation in albinterferon alfa-2b and the role of oxidation in its conformation and aggregation

Autor: Mark C. Manning, John F. Carpenter, Rajesh Krishnamurthy, Theodore W. Randolph, Danny K. Chou

Publikováno v: Journal of pharmaceutical sciences. 102(2)

Physical and chemical degradation of therapeutic proteins can occur simultane- ously. In this study, our first objective was to investigate how solution conditions that impact conformational stability of albinterferon alfa-2b, a recombinant fusion pr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74f877c07acb2b766b048c2050453fbe
https://pubmed.ncbi.nlm.nih.gov/23203978

Zobrazit plný text záznamu

Physical stability of albinterferon-α(2b) in aqueous solution: effects of conformational stability and colloidal stability on aggregation

Autor: Rajesh Krishnamurthy, Theodore W. Randolph, Mark C. Manning, Danny K. Chou, John F. Carpenter

Publikováno v: Journal of pharmaceutical sciences. 101(8)

Controlling aggregation in protein therapeutics is a significant challenge. In this study, the aggregation behavior of albinterferon-α(2b) , a genetic fusion protein combining human serum albumin and α-interferon, was examined as a function of solu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc146cfde814a7fed51373acfc15032c
https://pubmed.ncbi.nlm.nih.gov/22674119

Zobrazit plný text záznamu

Vyhledávací nástroje:

Upřesnit hledání