Zobrazeno 1 - 4
of 4
pro vyhledávání: '"Valeria Gervasi"'
Publikováno v:
AAPS Open, Vol 8, Iss 1, Pp 1-20 (2022)
Abstract A holistic approach was taken to characterise lyophilisers at both laboratory and commercial scale to design a focused validation strategy for commercialising parenteral drug products. Vial heat transfer coefficients (Kv) and equipment mass
Externí odkaz:
https://doaj.org/article/7ead331c101842d29fa315bec5f96bdb
Autor:
Elena Presas, Eric Sultan, Abina M. Crean, Valeria Gervasi, Didier Bazile, Ulrich Werner, Caitriona M. O'Driscoll
Publikováno v:
Drug development and industrial pharmacy. 46(7)
Long-term stability is one of the main challenges for translation of therapeutic proteins into commercially viable biopharmaceutical products. During processing and storage, proteins are susceptible to denaturation. The aim of this work was to evalua
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::22d7cc5eb46c2ba97aa969210083fb3a
https://pubmed.ncbi.nlm.nih.gov/32478645
https://pubmed.ncbi.nlm.nih.gov/32478645
Publikováno v:
International journal of pharmaceutics. 572
During lyophilisation cycle design, primary drying parameters (chamber pressure and shelf temperature) are adjusted to maximize the sublimation rate and prevent cake collapse, by maintaining the product continuously below its critical temperatures. T
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::31c42f76bdbb09b37f808dd97338fc8c
https://pubmed.ncbi.nlm.nih.gov/31678526
https://pubmed.ncbi.nlm.nih.gov/31678526
The study presented is a comprehensive overview of commercial parenteral protein formulations, approved by the European Medicines Agency (EMA), 1995-2018. The objective of this overview was to analyse current trends in the design of commercial parent
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d1f965fca38240803a538160bd1ce94b
https://hdl.handle.net/10468/6601
https://hdl.handle.net/10468/6601
