Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Jakob W. Buecheler"'
Autor:
Oliver Bluemel, Moritz Anuschek, Jakob W. Buecheler, Georg Hoelzl, Karoline Bechtold-Peters, Wolfgang Friess
Publikováno v:
International Journal of Pharmaceutics: X, Vol 4, Iss , Pp 100108- (2022)
Cryoconcentration upon large-scale freezing of monoclonal antibody (mAb) solutions leads to regions of different ratios of low molecular weight excipients, like buffer species or sugars, to protein. This study focused on the impact of the buffer spec
Externí odkaz:
https://doaj.org/article/fd256466ddc24d6b90e2553153595503
Autor:
Oliver Bluemel, Jakob W. Buecheler, Astrid Hauptmann, Georg Hoelzl, Karoline Bechtold-Peters, Wolfgang Friess
Publikováno v:
International Journal of Pharmaceutics: X, Vol 4, Iss , Pp 100109- (2022)
We examined the impact of monoclonal antibody (mAb) and buffer concentration, mimicking the cryoconcentration found upon freezing in a 2 L bottle, on mAb stability during frozen storage. Upon cryoconcentration, larger protein molecules and small exci
Externí odkaz:
https://doaj.org/article/102d6db52a574b688c2bf0c48f47b113
Autor:
Oliver Bluemel, Miguel A. Rodrigues, Jakob W. Buecheler, Vitor Geraldes, Georg Hoelzl, Astrid Hauptmann, Karoline Bechtold-Peters, Wolfgang Friess
Publikováno v:
Journal of Pharmaceutical Sciences. 111:1973-1983
There is a need for representative small volume devices that reflect monoclonal antibody (mAb) aggregation during freezing and thawing (FT) in large containers. We characterised two novel devices that aim to mimic the stress in rectangular 2 L bottle
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0bbb69c5aa91950ea50f9a1f025d2451
https://doi.org/10.1016/j.xphs.2022.01.003
https://doi.org/10.1016/j.xphs.2022.01.003
Autor:
Karoline Bechtold-Peters, Astrid Hauptmann, Oliver Bluemel, Georg Hoelzl, Wolfgang Friess, Jakob W. Buecheler
Publikováno v:
Pharmaceutical Research
Purpose Scale-down devices (SDD) are designed to simulate large-scale thawing of protein drug substance, but require only a fraction of the material. To evaluate the performance of a new SDD that aims to predict thawing in large-scale 2 L bottles, we
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31b7a28b9c854310f56b3d3443476d66
https://doi.org/10.1007/s11095-021-03117-6
https://doi.org/10.1007/s11095-021-03117-6
Autor:
Oliver Bluemel, Jakob W. Buecheler, Astrid Hauptmann, Georg Hoelzl, Karoline Bechtold-Peters, Wolfgang Friess
Publikováno v:
International Journal of Pharmaceutics: X
International Journal of Pharmaceutics: X, Vol 4, Iss, Pp 100109-(2022)
International Journal of Pharmaceutics: X, Vol 4, Iss, Pp 100109-(2022)
We examined the impact of monoclonal antibody (mAb) and buffer concentration, mimicking the cryoconcentration found upon freezing in a 2 L bottle, on mAb stability during frozen storage. Upon cryoconcentration, larger protein molecules and small exci
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48554eb16d78e5b0127bc646e9ca6ea7
https://pubmed.ncbi.nlm.nih.gov/35024604
https://pubmed.ncbi.nlm.nih.gov/35024604
Autor:
Jakob W. Buecheler, Georg Hoelzl, Oliver Bluemel, Miguel Rodrigues, Wolfgang Friess, Karoline Bechtold-Peters, Vítor Geraldes
Publikováno v:
Pharmaceutical Research. 37
Small-scale models that simulate large-scale freezing of bulk drug substance of biopharmaceuticals are highly needed to define freezing and formulation parameters based on process understanding. We evaluated a novel scale-down device (SDD), which is
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::7b4d9185238181294f522f80ae440389
https://doi.org/10.1007/s11095-020-02886-w
https://doi.org/10.1007/s11095-020-02886-w
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 73:111-120
The capping of vials plays a critical role in drug product manufacturing process due to its complex interplay of several adjustable process steps. Seal quality, integrity and assurance of containment is essential for parenteral pharmaceuticals as the
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbbab986821cbd6b5250790368f9a484
https://doi.org/10.5731/pdajpst.2018.008870
https://doi.org/10.5731/pdajpst.2018.008870
Publikováno v:
Molecular Pharmaceutics. 15:2656-2664
In silico screening of toxin payloads typically employed in ADCs revealed a wide range of hydrophobicities and sizes as measured by log P and topological polar surface area (tPSA) values. These descriptors were used to identify three nontoxic surroga
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d1cc5ffc8443a43ce7df52afb004c22e
https://doi.org/10.1021/acs.molpharmaceut.8b00177
https://doi.org/10.1021/acs.molpharmaceut.8b00177
Publikováno v:
Journal of pharmaceutical sciences. 108(3)
Oxidation of biopharmaceutics represents a major degradation pathway, which may impact bioactivity, serum half-life, and colloidal stability. This study focused on the quantification of oxidation and its effects on structure and colloidal stability f
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9cd83580112b87051c57654c1cf01856
https://pubmed.ncbi.nlm.nih.gov/30389566
https://pubmed.ncbi.nlm.nih.gov/30389566
Publikováno v:
The Journal of pharmacy and pharmacology. 70(5)
Objectives Oxidation of protein therapeutics is a major chemical degradation pathway which may impact bioactivity, serum half-life and stability. Therefore, oxidation is a relevant parameter which has to be monitored throughout formulation developmen
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::750d3a05bb8f9bddfe03a9ee8f4c231f
https://pubmed.ncbi.nlm.nih.gov/29380379
https://pubmed.ncbi.nlm.nih.gov/29380379