Zobrazeno 1 - 10
of 36
pro vyhledávání: '"Daniel C. Capaldi"'
Autor:
Tom Atherton, Carl Heatherington, Ulrike Rieder, Robert Peter, Thomas De Vijlder, Rainer Wechselberger, Francis Ring, Joerg Hoernschemeyer, Jessica A. Stolee, David Benstead, Ayman Charaf, Hong Jiang, Daniel C. Capaldi, Nadim Akhtar
Publikováno v:
Nucleic Acid Therapeutics. 30:249-264
A risk-based approach for routine identity testing of therapeutic oligonucleotide drug substances and drug products is described. Risk analysis of solid-phase oligonucleotide synthesis indicates that intact mass measurement is a powerful technique fo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c25dac9cb2bebc07dd39c91980bc3e71
https://doi.org/10.1089/nat.2020.0878
https://doi.org/10.1089/nat.2020.0878
Publikováno v:
Organic Process Research & Development. 24:2583-2590
A revised, optimized process for the manufacture of 5′-O-(4,4′-dimethoxytrityl)-N2-isobutyryl-2′-O-(2-methoxyethyl)guanosine (MOE G PNS) that controls critical impurities to less than 0.2% was deve...
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ba93cb50c771c55f1ca2aa33c08d7c34
https://doi.org/10.1021/acs.oprd.0c00261
https://doi.org/10.1021/acs.oprd.0c00261
Impurity Qualification Toxicology Study for a 2′-O-Methoxyethyl-Modified Antisense Inhibitor in Mice
Autor:
Andrew McPherson, Scott P. Henry, David Serota, Daniel C. Capaldi, Christine Hoffmaster, Nhuy Luu, Farah Mahdi, Tae-Won Kim, Andrew A. Rodriguez, Chris Papagiannis
Publikováno v:
Nucleic Acid Therapeutics. 30:14-21
Safety assessment of drug impurities is a routine part of the drug development process. For oligonucleotide-based drugs, impurities can arise from impurities in starting materials, as by-products of the manufacturing process or from degradation, and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::54f99d214878773961d132295dbdea87
https://doi.org/10.1089/nat.2019.0780
https://doi.org/10.1089/nat.2019.0780
Publikováno v:
Rapid Communications in Mass Spectrometry. 33:1774-1780
Phosphorothioate oligonucleotide drugs typically contain product-related impurities that are difficult to resolve chromatographically from the parent oligonucleotide due to the size of these compounds and the large number of stereoisomers that compri
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8cb9e357170e00217b001998fad285ce
https://doi.org/10.1002/rcm.8516
https://doi.org/10.1002/rcm.8516
Autor:
Jonathan Chan, Stilianos G. Roussis, Jaimie DaCosta, Claus Rentel, Daniel C. Capaldi, Bao Mai
Publikováno v:
Journal of Pharmaceutical and Biomedical Analysis. 173:56-61
A novel analytical approach capable of measuring deaminated degradation products of oligonucleotide therapeutics is described. The method employs high-resolution mass spectrometry to assess the shift in isotopic distribution that accompanies deaminat
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8173087ee61282200c1ae19d3a021adf
https://doi.org/10.1016/j.jpba.2019.05.012
https://doi.org/10.1016/j.jpba.2019.05.012
Publikováno v:
Rapid Communications in Mass Spectrometry. 32:1099-1106
Rationale Quantitative Ion-Pair (IP)-HPLC MS methods are employed to determine the complex impurity profiles of oligonucleotide therapeutics. While impurities that co-elute with the main product are routinely monitored, the large number of early and
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::08ee0099f28c9d9e0003ca2698f03677
https://doi.org/10.1002/rcm.8125
https://doi.org/10.1002/rcm.8125
Autor:
Samantha Gao-Sheridan, Neal Sharpe, Brigitte Burm, Jeffrey W.-D. Foy, Andy Teasdale, Daniel C. Capaldi, Scott P. Henry, Cathaline den Besten, Matthias Kretschmer, Nadim Akhtar, Ben Andrews
Publikováno v:
Nucleic Acid Therapeutics. 27:309-322
This white paper, which is the 10th in a series intended to address issues associated with the development of therapeutic oligonucleotides, examines the subject of product-related impurities. The authors consider chemistry and safety aspects and adva
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::44473bdb213b9944ea0a58a22446df3b
https://doi.org/10.1089/nat.2017.0691
https://doi.org/10.1089/nat.2017.0691
Autor:
Daniel C. Capaldi
INTRODUCTION The specifi c binding of synthetic oligonucleotides to cellular RNA through Watson-Crick base pairing can result in modulation of gene expression. This is the basis of the antisense concept, the therapeutic potential of which was fi rst
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::7432d043ab57d17f26702ca88bb56f7c
https://doi.org/10.3109/9781439801802-19
https://doi.org/10.3109/9781439801802-19
Autor:
Daren S. Levin, Bernhard Noll, B.P. (Bob) Sharma, Rao V. B. Kambhampati, René Thürmer, Ramesh Raghavachari, Fran Wincott, Daniel C. Capaldi, Ken Draper, Doug Brooks, James V. McArdle, Judy Carmody, Ipsita Roymoulik, Kathy Ackley, Matthias Kretschmer
Publikováno v:
Drug Information Journal. 46:611-626
This article, which is the first in a planned series intended to address chemistry, manufacturing, and control (CMC) aspects of therapeutic oligonucleotides, examines the topic of specifications for active pharmaceutical ingredients (APIs). The autho
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0c60ef9da19bf975fa73594a77cbe4f4
https://doi.org/10.1177/0092861512445311
https://doi.org/10.1177/0092861512445311
Autor:
Vasulinga T. Ravikumar, Nhuy Luu, James V. McArdle, Isaiah Cedillo, Kym Bradley, Kent Van Sooy, Christine Kurata, Daniel C. Capaldi, Hans Gaus
Publikováno v:
Bioorganic & Medicinal Chemistry Letters. 16:607-614
Phosphorothioate oligonucleotides manufactured by standard phosphoramidite techniques using 2'-deoxyadenosine- or 2'-O-(2-methoxyethyl)-5-methylcytosine-loaded solid supports contain branched impurities consisting of two chains linked through the exo
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::35314c892fb45f6c56f3f79c4ff2d129
https://doi.org/10.1016/j.bmcl.2005.10.051
https://doi.org/10.1016/j.bmcl.2005.10.051