Matches in SemOpenAlex for { <https://semopenalex.org/work/W2065390695> ?p ?o ?g. }
Showing items 1 to 92 of
92
with 100 items per page.
- W2065390695 endingPage "326" @default.
- W2065390695 startingPage "314" @default.
- W2065390695 abstract "Vial “Fogging” is a phenomenon observed after lyophilization due to drug product creeping upwards along the inner vial surface. After the freeze-drying process, a haze of dried powder is visible inside the drug product vial, making it barely acceptable for commercial distribution from a cosmetic point of view. Development studies were performed to identify the root cause for fogging during manufacturing of a lyophilized monoclonal antibody drug product. The results of the studies indicate that drug product creeping occurs during the filling process, leading to vial fogging after lyophilization. Glass quality/inner surface, glass conversion/vial processing (vial “history”) and formulation excipients, e.g., surfactants (three different surfactants were tested), all affect glass fogging to a certain degree. Results showed that the main factor to control fogging is primarily the inner vial surface hydrophilicity/hydrophobicity. While Duran vials were not capable of reliably improving the level of fogging, hydrophobic containers provided reliable means to improve the cosmetic appearance due to reduction in fogging. Varying vial depyrogenation treatment conditions did not lead to satisfying results in removal of the fogging effect. Processing conditions of the vial after filling with drug product had a strong impact on reducing but not eliminating fogging." @default.
- W2065390695 created "2016-06-24" @default.
- W2065390695 creator A5001809020 @default.
- W2065390695 creator A5004911157 @default.
- W2065390695 creator A5046261928 @default.
- W2065390695 creator A5052151636 @default.
- W2065390695 creator A5056287301 @default.
- W2065390695 creator A5072764736 @default.
- W2065390695 creator A5087198369 @default.
- W2065390695 date "2013-10-01" @default.
- W2065390695 modified "2023-09-27" @default.
- W2065390695 title "Investigating factors leading to fogging of glass vials in lyophilized drug products" @default.
- W2065390695 cites W1523968129 @default.
- W2065390695 cites W1965305857 @default.
- W2065390695 cites W1967889181 @default.
- W2065390695 cites W1976948929 @default.
- W2065390695 cites W1988834123 @default.
- W2065390695 cites W2010686926 @default.
- W2065390695 cites W2021857692 @default.
- W2065390695 cites W2033071931 @default.
- W2065390695 cites W2043178920 @default.
- W2065390695 cites W2044712794 @default.
- W2065390695 cites W2054187364 @default.
- W2065390695 cites W2061567046 @default.
- W2065390695 cites W2091317790 @default.
- W2065390695 cites W2123198322 @default.
- W2065390695 cites W2149385921 @default.
- W2065390695 cites W2155857435 @default.
- W2065390695 cites W2951515498 @default.
- W2065390695 doi "https://doi.org/10.1016/j.ejpb.2013.06.007" @default.
- W2065390695 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23791681" @default.
- W2065390695 hasPublicationYear "2013" @default.
- W2065390695 type Work @default.
- W2065390695 sameAs 2065390695 @default.
- W2065390695 citedByCount "37" @default.
- W2065390695 countsByYear W20653906952015 @default.
- W2065390695 countsByYear W20653906952016 @default.
- W2065390695 countsByYear W20653906952017 @default.
- W2065390695 countsByYear W20653906952018 @default.
- W2065390695 countsByYear W20653906952019 @default.
- W2065390695 countsByYear W20653906952020 @default.
- W2065390695 countsByYear W20653906952021 @default.
- W2065390695 countsByYear W20653906952022 @default.
- W2065390695 countsByYear W20653906952023 @default.
- W2065390695 crossrefType "journal-article" @default.
- W2065390695 hasAuthorship W2065390695A5001809020 @default.
- W2065390695 hasAuthorship W2065390695A5004911157 @default.
- W2065390695 hasAuthorship W2065390695A5046261928 @default.
- W2065390695 hasAuthorship W2065390695A5052151636 @default.
- W2065390695 hasAuthorship W2065390695A5056287301 @default.
- W2065390695 hasAuthorship W2065390695A5072764736 @default.
- W2065390695 hasAuthorship W2065390695A5087198369 @default.
- W2065390695 hasConcept C126838900 @default.
- W2065390695 hasConcept C159985019 @default.
- W2065390695 hasConcept C185592680 @default.
- W2065390695 hasConcept C192562407 @default.
- W2065390695 hasConcept C2776811147 @default.
- W2065390695 hasConcept C2781290227 @default.
- W2065390695 hasConcept C43617362 @default.
- W2065390695 hasConcept C71924100 @default.
- W2065390695 hasConcept C72092618 @default.
- W2065390695 hasConceptScore W2065390695C126838900 @default.
- W2065390695 hasConceptScore W2065390695C159985019 @default.
- W2065390695 hasConceptScore W2065390695C185592680 @default.
- W2065390695 hasConceptScore W2065390695C192562407 @default.
- W2065390695 hasConceptScore W2065390695C2776811147 @default.
- W2065390695 hasConceptScore W2065390695C2781290227 @default.
- W2065390695 hasConceptScore W2065390695C43617362 @default.
- W2065390695 hasConceptScore W2065390695C71924100 @default.
- W2065390695 hasConceptScore W2065390695C72092618 @default.
- W2065390695 hasIssue "2" @default.
- W2065390695 hasLocation W20653906951 @default.
- W2065390695 hasLocation W20653906952 @default.
- W2065390695 hasOpenAccess W2065390695 @default.
- W2065390695 hasPrimaryLocation W20653906951 @default.
- W2065390695 hasRelatedWork W135992753 @default.
- W2065390695 hasRelatedWork W180279838 @default.
- W2065390695 hasRelatedWork W1970095821 @default.
- W2065390695 hasRelatedWork W2065390695 @default.
- W2065390695 hasRelatedWork W2111364743 @default.
- W2065390695 hasRelatedWork W2413393931 @default.
- W2065390695 hasRelatedWork W2895812265 @default.
- W2065390695 hasRelatedWork W2899084033 @default.
- W2065390695 hasRelatedWork W2970555536 @default.
- W2065390695 hasRelatedWork W4324128692 @default.
- W2065390695 hasVolume "85" @default.
- W2065390695 isParatext "false" @default.
- W2065390695 isRetracted "false" @default.
- W2065390695 magId "2065390695" @default.
- W2065390695 workType "article" @default.