Matches in SemOpenAlex for { <https://semopenalex.org/work/W2891808492> ?p ?o ?g. }
Showing items 1 to 90 of
90
with 100 items per page.
- W2891808492 endingPage "143" @default.
- W2891808492 startingPage "137" @default.
- W2891808492 abstract "The focus of pharmaceutical product development lies on assuring excellent product quality at the end of a cost-efficient process. The Quality-by-Design (QbD) concept shifts the focus from quality assurance through testing to quality control by process understanding, resulting in very robust processes with high quality product. QbD was originally intended by authorities for biologics, where product quality proven completely by analytics is not desired. Product quality has to be controlled by means of appropriate processes and operations as well. These demands were developed in order to improve patients’ safety by optimal drug quality at more efficient manufacturing processes reducing costs for healthcare systems. Furthermore, production of bio- logics includes feedstock variability and complex multi-step manufacturing processes in batch operation with variable lots –condition, which apply to botanicals as well. The use of rigorous (physico-chemical) process modeling in combination with QbD results in a high degree of process understanding. This offers, contrary to popular prejudices, great benefit for manufac- turers with little extra effort during development. The methodical QbD-based approach is pursued to develop a process for extraction and purification of 10-deacetylbaccatin III from yew needles. A short history and key elements of the QbD-based application are introduced. The line of argument for basic process conception is described and initial risk assessment is shown. Typical raw material variation and vaporization are identified as causes of process variability, therefore, the implications to subsequent process steps are pointed out. Finally, influences of load and flow rate on the chromatographic separation of 10-deacetylbaccatin III are shown to exemplify sensitivity of purifica- tion design." @default.
- W2891808492 created "2018-09-27" @default.
- W2891808492 creator A5008929943 @default.
- W2891808492 creator A5012455128 @default.
- W2891808492 creator A5044900422 @default.
- W2891808492 date "2017-06-04" @default.
- W2891808492 modified "2023-09-27" @default.
- W2891808492 title "Quality-by-Design (QbD) process evaluation for phytopharmaceuticals on the example of 10-deacetylbaccatin III from yew" @default.
- W2891808492 doi "https://doi.org/10.18799/24056529/2017/2/125" @default.
- W2891808492 hasPublicationYear "2017" @default.
- W2891808492 type Work @default.
- W2891808492 sameAs 2891808492 @default.
- W2891808492 citedByCount "0" @default.
- W2891808492 crossrefType "journal-article" @default.
- W2891808492 hasAuthorship W2891808492A5008929943 @default.
- W2891808492 hasAuthorship W2891808492A5012455128 @default.
- W2891808492 hasAuthorship W2891808492A5044900422 @default.
- W2891808492 hasBestOaLocation W28918084921 @default.
- W2891808492 hasConcept C106436119 @default.
- W2891808492 hasConcept C111472728 @default.
- W2891808492 hasConcept C111919701 @default.
- W2891808492 hasConcept C112930515 @default.
- W2891808492 hasConcept C117671659 @default.
- W2891808492 hasConcept C127413603 @default.
- W2891808492 hasConcept C138885662 @default.
- W2891808492 hasConcept C144133560 @default.
- W2891808492 hasConcept C183696295 @default.
- W2891808492 hasConcept C200601418 @default.
- W2891808492 hasConcept C204320433 @default.
- W2891808492 hasConcept C21547014 @default.
- W2891808492 hasConcept C21880701 @default.
- W2891808492 hasConcept C2524010 @default.
- W2891808492 hasConcept C2776207758 @default.
- W2891808492 hasConcept C2778618615 @default.
- W2891808492 hasConcept C2778938233 @default.
- W2891808492 hasConcept C2779530757 @default.
- W2891808492 hasConcept C33923547 @default.
- W2891808492 hasConcept C41008148 @default.
- W2891808492 hasConcept C54725748 @default.
- W2891808492 hasConcept C55396564 @default.
- W2891808492 hasConcept C60644358 @default.
- W2891808492 hasConcept C86803240 @default.
- W2891808492 hasConcept C90673727 @default.
- W2891808492 hasConcept C98045186 @default.
- W2891808492 hasConceptScore W2891808492C106436119 @default.
- W2891808492 hasConceptScore W2891808492C111472728 @default.
- W2891808492 hasConceptScore W2891808492C111919701 @default.
- W2891808492 hasConceptScore W2891808492C112930515 @default.
- W2891808492 hasConceptScore W2891808492C117671659 @default.
- W2891808492 hasConceptScore W2891808492C127413603 @default.
- W2891808492 hasConceptScore W2891808492C138885662 @default.
- W2891808492 hasConceptScore W2891808492C144133560 @default.
- W2891808492 hasConceptScore W2891808492C183696295 @default.
- W2891808492 hasConceptScore W2891808492C200601418 @default.
- W2891808492 hasConceptScore W2891808492C204320433 @default.
- W2891808492 hasConceptScore W2891808492C21547014 @default.
- W2891808492 hasConceptScore W2891808492C21880701 @default.
- W2891808492 hasConceptScore W2891808492C2524010 @default.
- W2891808492 hasConceptScore W2891808492C2776207758 @default.
- W2891808492 hasConceptScore W2891808492C2778618615 @default.
- W2891808492 hasConceptScore W2891808492C2778938233 @default.
- W2891808492 hasConceptScore W2891808492C2779530757 @default.
- W2891808492 hasConceptScore W2891808492C33923547 @default.
- W2891808492 hasConceptScore W2891808492C41008148 @default.
- W2891808492 hasConceptScore W2891808492C54725748 @default.
- W2891808492 hasConceptScore W2891808492C55396564 @default.
- W2891808492 hasConceptScore W2891808492C60644358 @default.
- W2891808492 hasConceptScore W2891808492C86803240 @default.
- W2891808492 hasConceptScore W2891808492C90673727 @default.
- W2891808492 hasConceptScore W2891808492C98045186 @default.
- W2891808492 hasIssue "2" @default.
- W2891808492 hasLocation W28918084921 @default.
- W2891808492 hasOpenAccess W2891808492 @default.
- W2891808492 hasPrimaryLocation W28918084921 @default.
- W2891808492 hasRelatedWork W2073750282 @default.
- W2891808492 hasRelatedWork W2109319010 @default.
- W2891808492 hasRelatedWork W2188196462 @default.
- W2891808492 hasRelatedWork W2347810345 @default.
- W2891808492 hasRelatedWork W2889976499 @default.
- W2891808492 hasRelatedWork W3162236791 @default.
- W2891808492 hasRelatedWork W3195764032 @default.
- W2891808492 hasRelatedWork W4225261203 @default.
- W2891808492 hasRelatedWork W4226492197 @default.
- W2891808492 hasRelatedWork W4283829432 @default.
- W2891808492 isParatext "false" @default.
- W2891808492 isRetracted "false" @default.
- W2891808492 magId "2891808492" @default.
- W2891808492 workType "article" @default.