FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4309673733> ?p ?o ?g. }

• W4309673733 abstract "Abstract The genome content of adeno-associated virus (AAV) vectors is critical to the safety and potency of AAV-based gene therapy products. Empty capsids are considered a product-related impurity and a critical quality attribute (CQA) of the drug product, thus requiring characterization throughout the production process to demonstrate they are controlled to acceptable levels in the final drug product. Anion exchange chromatography has been used to achieve separation between empty and full capsids, but requires method development and gradient optimization for different serotypes and formulations. Here, we describe an alternative approach to quantitation that does not rely on achieving separation between empty and full capsids, but instead uses the well-established relationship between absorbance at UV A 260 / A 280 and relation to DNA/protein content, in combination with anion-exchange chromatography to allow one to calculate the relative proportion of empty and full capsids in AAV samples from a single peak. We call this approach ACUVRA: A nion-exchange C hromatography UV - R atio A nalysis, and show the applicability of the method through a case study with recombinant AAV2 (rAAV2) process intermediates and drug substance. Method qualification and GMP validation in a quality control (QC) laboratory results show that ACUVRA is a fit-for-purpose method for process development support and characterization, while also being a QC-friendly option for GMP release testing at all stages of clinical development." @default.
• W4309673733 created "2022-11-29" @default.
• W4309673733 creator A5007758316 @default.
• W4309673733 creator A5021236664 @default.
• W4309673733 creator A5044976216 @default.
• W4309673733 creator A5046619986 @default.
• W4309673733 creator A5046742692 @default.
• W4309673733 creator A5049145283 @default.
• W4309673733 creator A5057786239 @default.
• W4309673733 creator A5066170377 @default.
• W4309673733 creator A5077525692 @default.
• W4309673733 date "2022-11-22" @default.
• W4309673733 modified "2023-10-14" @default.
• W4309673733 title "ACUVRA: Anion-Exchange Chromatography UV-Ratio Analysis—A QC-Friendly Method for Monitoring Adeno-Associated Virus Empty Capsid Content To Support Process Development and GMP Release Testing" @default.
• W4309673733 cites W1583078809 @default.
• W4309673733 cites W1795014780 @default.
• W4309673733 cites W1978564724 @default.
• W4309673733 cites W2005986251 @default.
• W4309673733 cites W2033280375 @default.
• W4309673733 cites W2052621353 @default.
• W4309673733 cites W2053755635 @default.
• W4309673733 cites W2058942457 @default.
• W4309673733 cites W2086866768 @default.
• W4309673733 cites W2087877297 @default.
• W4309673733 cites W2154370603 @default.
• W4309673733 cites W2324542890 @default.
• W4309673733 cites W2623463662 @default.
• W4309673733 cites W2913212173 @default.
• W4309673733 cites W2962334628 @default.
• W4309673733 cites W2964135966 @default.
• W4309673733 cites W2965347002 @default.
• W4309673733 cites W2975867742 @default.
• W4309673733 cites W2987565474 @default.
• W4309673733 cites W3008020475 @default.
• W4309673733 cites W3035851635 @default.
• W4309673733 cites W3088224260 @default.
• W4309673733 cites W3089145911 @default.
• W4309673733 cites W3106400806 @default.
• W4309673733 cites W3126192584 @default.
• W4309673733 cites W3134311741 @default.
• W4309673733 cites W3194611711 @default.
• W4309673733 cites W3216510728 @default.
• W4309673733 doi "https://doi.org/10.1208/s12248-022-00768-0" @default.
• W4309673733 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36414847" @default.
• W4309673733 hasPublicationYear "2022" @default.
• W4309673733 type Work @default.
• W4309673733 citedByCount "1" @default.
• W4309673733 countsByYear W43096737332023 @default.
• W4309673733 crossrefType "journal-article" @default.
• W4309673733 hasAuthorship W4309673733A5007758316 @default.
• W4309673733 hasAuthorship W4309673733A5021236664 @default.
• W4309673733 hasAuthorship W4309673733A5044976216 @default.
• W4309673733 hasAuthorship W4309673733A5046619986 @default.
• W4309673733 hasAuthorship W4309673733A5046742692 @default.
• W4309673733 hasAuthorship W4309673733A5049145283 @default.
• W4309673733 hasAuthorship W4309673733A5057786239 @default.
• W4309673733 hasAuthorship W4309673733A5066170377 @default.
• W4309673733 hasAuthorship W4309673733A5077525692 @default.
• W4309673733 hasBestOaLocation W43096737331 @default.
• W4309673733 hasConcept C104317684 @default.
• W4309673733 hasConcept C117760992 @default.
• W4309673733 hasConcept C145148216 @default.
• W4309673733 hasConcept C147789679 @default.
• W4309673733 hasConcept C178790620 @default.
• W4309673733 hasConcept C185592680 @default.
• W4309673733 hasConcept C187530423 @default.
• W4309673733 hasConcept C202878990 @default.
• W4309673733 hasConcept C206967267 @default.
• W4309673733 hasConcept C2778107364 @default.
• W4309673733 hasConcept C2780449318 @default.
• W4309673733 hasConcept C40767141 @default.
• W4309673733 hasConcept C43617362 @default.
• W4309673733 hasConcept C55493867 @default.
• W4309673733 hasConcept C92087593 @default.
• W4309673733 hasConceptScore W4309673733C104317684 @default.
• W4309673733 hasConceptScore W4309673733C117760992 @default.
• W4309673733 hasConceptScore W4309673733C145148216 @default.
• W4309673733 hasConceptScore W4309673733C147789679 @default.
• W4309673733 hasConceptScore W4309673733C178790620 @default.
• W4309673733 hasConceptScore W4309673733C185592680 @default.
• W4309673733 hasConceptScore W4309673733C187530423 @default.
• W4309673733 hasConceptScore W4309673733C202878990 @default.
• W4309673733 hasConceptScore W4309673733C206967267 @default.
• W4309673733 hasConceptScore W4309673733C2778107364 @default.
• W4309673733 hasConceptScore W4309673733C2780449318 @default.
• W4309673733 hasConceptScore W4309673733C40767141 @default.
• W4309673733 hasConceptScore W4309673733C43617362 @default.
• W4309673733 hasConceptScore W4309673733C55493867 @default.
• W4309673733 hasConceptScore W4309673733C92087593 @default.
• W4309673733 hasIssue "1" @default.
• W4309673733 hasLocation W43096737331 @default.
• W4309673733 hasLocation W43096737332 @default.
• W4309673733 hasOpenAccess W4309673733 @default.
• W4309673733 hasPrimaryLocation W43096737331 @default.
• W4309673733 hasRelatedWork W1544804321 @default.
• W4309673733 hasRelatedWork W1978564724 @default.
• W4309673733 hasRelatedWork W2079090019 @default.
• W4309673733 hasRelatedWork W2346945891 @default.
• W4309673733 hasRelatedWork W3004737595 @default.
• W4309673733 hasRelatedWork W3047351693 @default.

• next