Matches in SemOpenAlex for { <https://semopenalex.org/work/W2023874544> ?p ?o ?g. }
Showing items 1 to 82 of
82
with 100 items per page.
- W2023874544 endingPage "S46" @default.
- W2023874544 startingPage "S46" @default.
- W2023874544 abstract "Defining a CMC strategy is a key element to successful product development, regardless of product type. In recent years, the implementation of the ATMP regulation and guidelines together with the new quality paradigms developed in ICH guidelines (Q8-10), and the refinement of GMP requirements (Annex 2), all encourage science and risk based approach to become an integrated part of product development. Identifying the CMC regulatory requirements at any given development stage provides the opportunity to reflect on the product, its specific characteristics and the potential technical challenges or limitation that one may face during the course of development. This set of information will be critical in defining the needs in terms of product characterization tools, production scales, comparability plans, risk mitigation etc. and will help drive priorities and efforts throughout development. This presentation will also discuss how anticipating the CTD content of Module 3 early on can help identify potential gaps and define a regulatory frame as it relate to CMC requirements which, combined with a risk based approach, become the foundation of the CMC strategy that one can build upon as development evolves. The presentation will also highlight the importance of the characterization tools to help feed an efficient development cycle build on process and product monitoring and on comparability. Learning objective: Understand the key elements of CMC differences between ATMP and other medicinal products and how they influence product development. Discuss the possible approaches to overcome technical and regulatory challenges and how the knowledge of product specificities can allow the integration of a risk based approach. Learn how the development of the appropriate characterization tools and early planning of comparability strategies are essential to successful product development and to the preparation of the Module 3." @default.
- W2023874544 created "2016-06-24" @default.
- W2023874544 creator A5021416619 @default.
- W2023874544 date "2014-04-01" @default.
- W2023874544 modified "2023-09-27" @default.
- W2023874544 title "Designing a CMC strategy for cell and gene therapy" @default.
- W2023874544 doi "https://doi.org/10.1016/j.jcyt.2014.01.163" @default.
- W2023874544 hasPublicationYear "2014" @default.
- W2023874544 type Work @default.
- W2023874544 sameAs 2023874544 @default.
- W2023874544 citedByCount "0" @default.
- W2023874544 crossrefType "journal-article" @default.
- W2023874544 hasAuthorship W2023874544A5021416619 @default.
- W2023874544 hasConcept C111472728 @default.
- W2023874544 hasConcept C111919701 @default.
- W2023874544 hasConcept C112930515 @default.
- W2023874544 hasConcept C114614502 @default.
- W2023874544 hasConcept C120823896 @default.
- W2023874544 hasConcept C126838900 @default.
- W2023874544 hasConcept C127413603 @default.
- W2023874544 hasConcept C138885662 @default.
- W2023874544 hasConcept C144133560 @default.
- W2023874544 hasConcept C162853370 @default.
- W2023874544 hasConcept C19351080 @default.
- W2023874544 hasConcept C195094911 @default.
- W2023874544 hasConcept C197947376 @default.
- W2023874544 hasConcept C201995342 @default.
- W2023874544 hasConcept C2524010 @default.
- W2023874544 hasConcept C2777601897 @default.
- W2023874544 hasConcept C2779530757 @default.
- W2023874544 hasConcept C2780449318 @default.
- W2023874544 hasConcept C33923547 @default.
- W2023874544 hasConcept C41008148 @default.
- W2023874544 hasConcept C45135082 @default.
- W2023874544 hasConcept C71924100 @default.
- W2023874544 hasConcept C90673727 @default.
- W2023874544 hasConcept C98045186 @default.
- W2023874544 hasConceptScore W2023874544C111472728 @default.
- W2023874544 hasConceptScore W2023874544C111919701 @default.
- W2023874544 hasConceptScore W2023874544C112930515 @default.
- W2023874544 hasConceptScore W2023874544C114614502 @default.
- W2023874544 hasConceptScore W2023874544C120823896 @default.
- W2023874544 hasConceptScore W2023874544C126838900 @default.
- W2023874544 hasConceptScore W2023874544C127413603 @default.
- W2023874544 hasConceptScore W2023874544C138885662 @default.
- W2023874544 hasConceptScore W2023874544C144133560 @default.
- W2023874544 hasConceptScore W2023874544C162853370 @default.
- W2023874544 hasConceptScore W2023874544C19351080 @default.
- W2023874544 hasConceptScore W2023874544C195094911 @default.
- W2023874544 hasConceptScore W2023874544C197947376 @default.
- W2023874544 hasConceptScore W2023874544C201995342 @default.
- W2023874544 hasConceptScore W2023874544C2524010 @default.
- W2023874544 hasConceptScore W2023874544C2777601897 @default.
- W2023874544 hasConceptScore W2023874544C2779530757 @default.
- W2023874544 hasConceptScore W2023874544C2780449318 @default.
- W2023874544 hasConceptScore W2023874544C33923547 @default.
- W2023874544 hasConceptScore W2023874544C41008148 @default.
- W2023874544 hasConceptScore W2023874544C45135082 @default.
- W2023874544 hasConceptScore W2023874544C71924100 @default.
- W2023874544 hasConceptScore W2023874544C90673727 @default.
- W2023874544 hasConceptScore W2023874544C98045186 @default.
- W2023874544 hasIssue "4" @default.
- W2023874544 hasLocation W20238745441 @default.
- W2023874544 hasOpenAccess W2023874544 @default.
- W2023874544 hasPrimaryLocation W20238745441 @default.
- W2023874544 hasRelatedWork W1567498295 @default.
- W2023874544 hasRelatedWork W1990944507 @default.
- W2023874544 hasRelatedWork W2185689662 @default.
- W2023874544 hasRelatedWork W2188196462 @default.
- W2023874544 hasRelatedWork W2326806379 @default.
- W2023874544 hasRelatedWork W2379011182 @default.
- W2023874544 hasRelatedWork W2783593393 @default.
- W2023874544 hasRelatedWork W2849916945 @default.
- W2023874544 hasRelatedWork W2895702363 @default.
- W2023874544 hasRelatedWork W2530248865 @default.
- W2023874544 hasVolume "16" @default.
- W2023874544 isParatext "false" @default.
- W2023874544 isRetracted "false" @default.
- W2023874544 magId "2023874544" @default.
- W2023874544 workType "article" @default.