Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Anthony Mire-Sluis"'
Autor:
Xu-Rong Jiang, Anthony Mire-Sluis
Publikováno v:
Biosimilars ISBN: 9783319996790
The measurement of biological activity is required for therapeutic antibodies at release of a new manufacturing batch and throughout the product life cycle. However, the applicable regulatory guidelines provide relatively little advice with respect t
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1478ca98e153b55fd0108c8ba0ba7d4d
https://doi.org/10.1007/978-3-319-99680-6_16
https://doi.org/10.1007/978-3-319-99680-6_16
Autor:
Bhavin S. Parekh, Robert Strouse, Thomas Arroll, Shan Chung, Kimberly May, Xu-Rong Jiang, Mark A. Schenerman, Anthony Mire-Sluis, Svetlana Bergelson, An Song
Publikováno v:
Nature Reviews Drug Discovery. 10:101-111
The Fc (crystallizable fragment) region of therapeutic antibodies can have an important role in their safety and efficacy. Although much is known about the structure-activity relationship of antibodies and the factors that influence Fc effector funct
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::1a1e2d4b5d03a67d9e6492e8a5a60056
https://doi.org/10.1038/nrd3365
https://doi.org/10.1038/nrd3365
Autor:
John F. Carpenter, Barry Cherney, Thomas Nikolai, Anthony Lubinecki, Jack A. Ragheb, Jeanne M. Novak, Stacey Ma, Anthony Mire-Sluis, Ewa Marszal, Jan Simak
Publikováno v:
Biologicals. 38:602-611
This meeting was successful in achieving its main goals: (1) summarize currently available information on the origin, detection, quantification and characterization of sub-visible particulates in protein products, available information on their clini
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::248cfbcb3c13bb9a25d162acf961b3ea
https://doi.org/10.1016/j.biologicals.2010.07.002
https://doi.org/10.1016/j.biologicals.2010.07.002
Autor:
Boris Gorovits, Gopi Shankar, Steven J. Swanson, Deborah Finco-Kent, Yuchen Barrett, Shalini Gupta, Holly W. Smith, Bonita Rup, Linda Zuckerman, Gary Taniguchi, Anthony Mire-Sluis, Valerie Quarmby, Michael Moxness, Viswanath Devanarayan, Thomas Parish, Elizabeth Shores, Eugen Koren, Christopher Stebbins
Publikováno v:
Journal of Immunological Methods. 333:1-9
The appropriate evaluation of the immunogenicity of biopharmaceuticals is of major importance for their successful development and licensure. Antibodies elicited by these products in many cases cause no detectable clinical effects in humans. However,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ad223c81deef9c582855cc5214e57742
https://doi.org/10.1016/j.jim.2008.01.001
https://doi.org/10.1016/j.jim.2008.01.001
Autor:
Thomas T. Kawabata, Eric Wakshull, Susan M. Richards, Steven J. Swanson, Vijay Jethwa, Elizabeth Shores, Stephen R. Indelicato, Anthony Mire-Sluis, Shalini Gupta, Bonita Rup, Marian Kelley
Publikováno v:
Journal of Immunological Methods. 321:1-18
The administration of biological therapeutics can evoke some level of immune response to the drug product in the receiving subjects. An immune response comprised of neutralizing antibodies can lead to loss of efficacy or potentially more serious clin
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::949a3de54e234fbf9e536b4fe910b27a
https://doi.org/10.1016/j.jim.2006.12.004
https://doi.org/10.1016/j.jim.2006.12.004
Autor:
Ping Yeh, Ingrid Markovic, Kim Li, Hans Lee, Ronald Forster, Anthony Mire-Sluis, Yasser Nashed-Samuel, Barry Cherney, Gary Rogers
Publikováno v:
PDA journal of pharmaceutical science and technology. 69(5)
The risk mitigation of extractables and leachables presents significant challenges to regulators and drug manufacturers with respect to the development, as well as the lifecycle management, of drug products. A holistic program is proposed, using a sc
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e44425672a923d051fd9995541dae8e8
https://pubmed.ncbi.nlm.nih.gov/26429108
https://pubmed.ncbi.nlm.nih.gov/26429108
Autor:
Anthony Mire-Sluis, Paul Chamberlain
Publikováno v:
Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector. 2:133-144
The registration of follow-on biologics will depend on the availability of data demonstrating comparability with a reference product. It is recognised that measurement of relative immunogenicity will be an important component of the product comparabi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a9ab2f142bf9d86a5956186806827fdd
https://doi.org/10.1057/palgrave.jgm.4940062
https://doi.org/10.1057/palgrave.jgm.4940062
Autor:
Anthony Mire-Sluis, Arthur J. Chirino
Publikováno v:
Nature Biotechnology. 22:1383-1391
Changes in production methods of a biological product may necessitate an assessment of comparability to ensure that these manufacturing changes have not affected the safety, identity, purity, or efficacy of the product. Depending on the nature of the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6a4be606ba45980f5886839b1c6d71f9
https://doi.org/10.1038/nbt1030
https://doi.org/10.1038/nbt1030
Autor:
Eugene Koren, Anthony Mire-Sluis, Steven J. Swanson, Linda Zuckerman, Daniel Wierda, Viswanath Devanarayan, Gary Taniguchi, Mauricio Maia, Elizabeth Shores, Gopi Shankar, Thomas Parish, Yu Chen Barrett, George Scott, Hank Liu
Publikováno v:
Journal of Immunological Methods. 289:1-16
Most biopharmaceutical therapeutics elicit some level of antibody response against the product. This antibody response can, in some cases, lead to potentially serious side effects and/or loss of efficacy. Therefore, the immunogenicity of therapeutic
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c59cc15fa15e51695c4c47c35b491980
https://doi.org/10.1016/j.jim.2004.06.002
https://doi.org/10.1016/j.jim.2004.06.002