Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Guillermo Miro-Quesada"'
Autor:
Jared A. Delmar, Eugen Buehler, Ashwin K. Chetty, Agastya Das, Guillermo Miro Quesada, Jihong Wang, Xiaoyu Chen
Publikováno v:
Molecular Therapy: Methods & Clinical Development, Vol 21, Iss , Pp 466-477 (2021)
Photooxidation of methionine (Met) and tryptophan (Trp) residues is common and includes major degradation pathways that often pose a serious threat to the success of therapeutic proteins. Oxidation impacts all steps of protein production, manufacturi
Externí odkaz:
https://doaj.org/article/5ce2900605144a59996010831a42b91a
Autor:
Stan Altan, Dhammika Amaratunga, Javier Cabrera, Jeonifer Garren, Helena Geys, John Kolassa, David LeBlond, Dingzhou Li, Jason Liao, Jia Liu, Mariusz Lubomirski, Guillermo Miro-Quesada, Steven Novick, Martin Otava, John Peterson, Katharina Reckermann, Tim Schofield, Charles Tan, Kanaka Tatikola, Fetene Tekle, Jennifer Thomas, Kim Vukovinsky
Publikováno v:
Statistics in Biopharmaceutical Research. 15:343-358
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::ee66dd5612364bd87ca6c5791014aa83
https://doi.org/10.1080/19466315.2022.2038258
https://doi.org/10.1080/19466315.2022.2038258
Autor:
Xiaoyu Chen, Jared A. Delmar, Agastya Das, Eugen Buehler, Guillermo Miro Quesada, Jihong Wang, Ashwin K. Chetty
Publikováno v:
Molecular Therapy: Methods & Clinical Development, Vol 21, Iss, Pp 466-477 (2021)
Molecular Therapy. Methods & Clinical Development
Molecular Therapy. Methods & Clinical Development
Photooxidation of methionine (Met) and tryptophan (Trp) residues is common and includes major degradation pathways that often pose a serious threat to the success of therapeutic proteins. Oxidation impacts all steps of protein production, manufacturi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::27634c8ab48b8b4a5cfffdf916af7c27
http://www.sciencedirect.com/science/article/pii/S2329050121000632
http://www.sciencedirect.com/science/article/pii/S2329050121000632
Publikováno v:
Biochemical Engineering Journal. 134:120-128
Fed-batch mammalian cell culture processes frequently employ concentrated and complex media and feeds during the production phase. Though significant efforts are undertaken to characterize the large-scale bioreactor with respect to its control parame
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6aaabb93ebfe4cd9d319b777df9b7de2
https://doi.org/10.1016/j.bej.2018.03.009
https://doi.org/10.1016/j.bej.2018.03.009
Autor:
Rahul Pradhan, Diane Hatton, Nitin Agarwal, Viv Lindo, Guillermo Miro-Quesada, James Savery, Jan Kemper, Jihong Wang, Dimitra Serfiotis-Mitsa, Alison Mason, Sanjeev Ahuja, Allen D. Bosley
Publikováno v:
Biotechnology progressREFERENCES. 35(5)
Glycation, the nonenzymatic reaction between the reducing sugar glucose and the primary amine residues on amino acid side chains, commonly occurs in the cell culture supernatant during production of therapeutic monoclonal antibodies (mAbs). While gly
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e78576925f4515148fc53701127bf048
https://pubmed.ncbi.nlm.nih.gov/31180183
https://pubmed.ncbi.nlm.nih.gov/31180183
Autor:
Raghavan Venkat, James Savery, Ronald Schoner, Krista Evans, Bhargavi Rajan, Thomas Albanetti, Christopher Groves, Guillermo Miro-Quesada
Publikováno v:
Biotechnology Progress
Regulatory authorities require that cell lines used in commercial production of recombinant proteins must be derived from a single cell progenitor or clone. The limiting dilution method of cell cloning required multiple rounds of low‐density cell p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eee75c7aea4841f3faf348369bbd3873
http://europepmc.org/articles/PMC5054913
http://europepmc.org/articles/PMC5054913
Autor:
Gargi Roy, Guillermo Miro-Quesada, Marcello Marelli, Jie Zhu, Herren Wu, Li Zhuang, Michael A. Bowen, Thomas D. Martin
Publikováno v:
Journal of immunological methods. 451
Screening and characterization of cell lines for stable production are critical tasks in identifying suitable recombinant cell lines for the manufacture of protein therapeutics. To aid this essential function we have developed a methodology for the s
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3dfd1763a22b8a4f0a0b0ffd9fcdd39c
https://pubmed.ncbi.nlm.nih.gov/28890364
https://pubmed.ncbi.nlm.nih.gov/28890364
Publikováno v:
Biotechnology progress. 34(3)
The manufacturing process for biotherapeutics is closely regulated by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies worldwide. To ensure consistency of the product of a manufacturing cell line,
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d9f279aea187ab53f6400620ae2491a2
https://pubmed.ncbi.nlm.nih.gov/28556621
https://pubmed.ncbi.nlm.nih.gov/28556621
Publikováno v:
Quality by Design for Biopharmaceutical Drug Product Development ISBN: 9781493923151
In a quality by design (QbD) program, once a process has been characterized and a design space is established, process control of critical quality attributes (CQAs) needs to be assessed and an integrated control strategy , including both process cont
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::68d6ab61dcd00e621a39b3747053dc20
https://doi.org/10.1007/978-1-4939-2316-8_21
https://doi.org/10.1007/978-1-4939-2316-8_21
Publikováno v:
Biologicals : journal of the International Association of Biological Standardization. 39(6)
Viral contamination of mammalian cell cultures in GMP manufacturing facility represents a serious safety threat to biopharmaceutical industry. Such adverse events usually require facility shutdown for cleaning/decontamination, and thus result in sign
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb23bd76cf2869b5e0d8c95c2da68096
https://pubmed.ncbi.nlm.nih.gov/21985900
https://pubmed.ncbi.nlm.nih.gov/21985900