Zobrazeno 1 - 10
of 18
pro vyhledávání: '"Ina Pahl"'
Publikováno v:
Scientific Reports, Vol 14, Iss 1, Pp 1-12 (2024)
Abstract Plastic components are essential in the pharmaceutical industry, encompassing container closure systems, laboratory handling equipment, and single-use systems. As part of their material qualification process, studies on interactions between
Externí odkaz:
https://doaj.org/article/a9e48b2bcc5e4cc58888ef316ed17922
Publikováno v:
International Journal of Pharmaceutics. 634:122677
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a93d43cd9901fa5f2838680e74dfca4f
https://doi.org/10.1016/j.ijpharm.2023.122677
https://doi.org/10.1016/j.ijpharm.2023.122677
Autor:
Elke Jurkiewicz, Roberto Menzel, Armin Hauk, Tanja Verena Maier, Helmar Görls, Dana Budde, Thomas Noll, Ina Pahl, Eric Täuscher
Publikováno v:
Analytical and Bioanalytical Chemistry. 412:4505-4518
The inhibiting effect of the secondary phosphite antioxidant degradation product bis(2,4-di-tert-butylphenyl)phosphate (bDtBPP) on cell growth is well-known. The present study describes structurally related compounds which are likely to be formed fro
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3affd6f0fc893d938212dc56766e459c
https://doi.org/10.1007/s00216-020-02736-z
https://doi.org/10.1007/s00216-020-02736-z
Publikováno v:
Biotechnology progress. 38(1)
The biopharmaceutical industry gains enormous flexibility in production processes by using sterilized preassembled single-use devices. Gamma irradiation is an established sterilization technology that may be restricted in the future by the availabili
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2a7bee104a283655c1f65828bd2a2ed0
https://pubmed.ncbi.nlm.nih.gov/34541835
https://pubmed.ncbi.nlm.nih.gov/34541835
Publikováno v:
Single-Use Technology in Biopharmaceutical Manufacture
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::55902b2ec8ab65105c0746b1e52fa03d
https://doi.org/10.1002/9781119477891.ch17
https://doi.org/10.1002/9781119477891.ch17
Publikováno v:
European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences. 163
Quantitative information on process equipment-related leachables (PERLs) is required for process qualification and within a safety assessment. Extractables data for single-use equipment are suitable and applicable if the extractables study conditions
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0108f58b473b2d46c9ea77a523773f02
https://pubmed.ncbi.nlm.nih.gov/33852970
https://pubmed.ncbi.nlm.nih.gov/33852970
Publikováno v:
European Journal of Pharmaceutical Sciences. 168:105982
Filtration is universally used in biopharmaceutical processing. For example, in upstream processing for sterilizing-grade filtration of cell culture media or in various downstream operations, such as clarification, filtration of intermediates, and in
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8c3153f7e65abbf43cf3cee1b1dc6805
https://doi.org/10.1016/j.ejps.2021.105982
https://doi.org/10.1016/j.ejps.2021.105982
Publikováno v:
European Journal of Pharmaceutical Sciences. 120:191-198
This publication describes the development of an experimental set-up and testing protocol to test the hypothesis that filters used for sterile filtration can act as scavengers of leachables. The filter materials polyethersulfone (PESU) and cellulose
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36dc02423877b111e1285b2bc7b027b3
https://doi.org/10.1016/j.ejps.2018.04.044
https://doi.org/10.1016/j.ejps.2018.04.044
Publikováno v:
Industrial & Engineering Chemistry Research. 57:7077-7089
Regulatory authorities require the biopharmaceutical industry to demonstrate that extractables that may migrate from production systems do not alter the safety, efficacy, potency, or purity of drug products. Extractables studies of polymeric material
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::acd95ff92fafcf7f14e1220224b93dca
https://doi.org/10.1021/acs.iecr.7b04940
https://doi.org/10.1021/acs.iecr.7b04940