FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W1603736948> ?p ?o ?g. }

• W1603736948 abstract "Process Analytical Technology (PAT) became a well-defined concept within the pharmaceutical industry as a result of a major initiative by the FDA called “Pharmaceutical cGMPs for the 21 Century: A Risk-Based Approach.” The FDA defines PAT as “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes, with the goal of ensuring final product quality.” The biotechnology industry has started incorporating PAT in manufacturing, because of regulatory pressure and because the previous blockbuster-oriented business model is becoming less viable. This thesis proposes a methodology for evaluating PAT systems and delivers guidance on how to develop and implement them to effectively manage risk in biopharmaceutical manufacturing. The methodology includes guidance regarding identifying opportunities, evaluating and implementing novel analytical technology, appropriately applying acquired data, and managing change associated with PAT implementation. Experimental results from a novel PAT system that acquires light scattering and UV absorbance data to control chromatography during large-scale manufacturing are presented as a case study. The case study follows the methodology to show how a system optimized for a laboratory can be scaled for use in biopharmaceutical manufacturing. Thesis Supervisor: Allan Myerson Title: Professor of the Practice of Chemical Engineering Thesis Supervisor: Roy Welsch Title: Professor of Statistics and Management Science, MIT Sloan School of Management" @default.
• W1603736948 created "2016-06-24" @default.
• W1603736948 creator A5065444954 @default.
• W1603736948 date "2013-01-01" @default.
• W1603736948 modified "2023-09-23" @default.
• W1603736948 title "Process Analytical Technology in biopharmaceutical manufacturing" @default.
• W1603736948 cites W1522029621 @default.
• W1603736948 cites W1568922671 @default.
• W1603736948 cites W1573263580 @default.
• W1603736948 cites W1589579867 @default.
• W1603736948 cites W3126949612 @default.
• W1603736948 hasPublicationYear "2013" @default.
• W1603736948 type Work @default.
• W1603736948 sameAs 1603736948 @default.
• W1603736948 citedByCount "0" @default.
• W1603736948 crossrefType "dissertation" @default.
• W1603736948 hasAuthorship W1603736948A5065444954 @default.
• W1603736948 hasConcept C110354214 @default.
• W1603736948 hasConcept C111472728 @default.
• W1603736948 hasConcept C111919701 @default.
• W1603736948 hasConcept C112930515 @default.
• W1603736948 hasConcept C117671659 @default.
• W1603736948 hasConcept C127413603 @default.
• W1603736948 hasConcept C138885662 @default.
• W1603736948 hasConcept C144133560 @default.
• W1603736948 hasConcept C174998907 @default.
• W1603736948 hasConcept C17744445 @default.
• W1603736948 hasConcept C178144697 @default.
• W1603736948 hasConcept C195094911 @default.
• W1603736948 hasConcept C199539241 @default.
• W1603736948 hasConcept C201995342 @default.
• W1603736948 hasConcept C204320433 @default.
• W1603736948 hasConcept C21547014 @default.
• W1603736948 hasConcept C2524010 @default.
• W1603736948 hasConcept C2776207758 @default.
• W1603736948 hasConcept C2778938233 @default.
• W1603736948 hasConcept C2779110517 @default.
• W1603736948 hasConcept C2779530757 @default.
• W1603736948 hasConcept C2781047461 @default.
• W1603736948 hasConcept C33923547 @default.
• W1603736948 hasConcept C41008148 @default.
• W1603736948 hasConcept C54355233 @default.
• W1603736948 hasConcept C60644358 @default.
• W1603736948 hasConcept C86803240 @default.
• W1603736948 hasConcept C90673727 @default.
• W1603736948 hasConcept C98045186 @default.
• W1603736948 hasConceptScore W1603736948C110354214 @default.
• W1603736948 hasConceptScore W1603736948C111472728 @default.
• W1603736948 hasConceptScore W1603736948C111919701 @default.
• W1603736948 hasConceptScore W1603736948C112930515 @default.
• W1603736948 hasConceptScore W1603736948C117671659 @default.
• W1603736948 hasConceptScore W1603736948C127413603 @default.
• W1603736948 hasConceptScore W1603736948C138885662 @default.
• W1603736948 hasConceptScore W1603736948C144133560 @default.
• W1603736948 hasConceptScore W1603736948C174998907 @default.
• W1603736948 hasConceptScore W1603736948C17744445 @default.
• W1603736948 hasConceptScore W1603736948C178144697 @default.
• W1603736948 hasConceptScore W1603736948C195094911 @default.
• W1603736948 hasConceptScore W1603736948C199539241 @default.
• W1603736948 hasConceptScore W1603736948C201995342 @default.
• W1603736948 hasConceptScore W1603736948C204320433 @default.
• W1603736948 hasConceptScore W1603736948C21547014 @default.
• W1603736948 hasConceptScore W1603736948C2524010 @default.
• W1603736948 hasConceptScore W1603736948C2776207758 @default.
• W1603736948 hasConceptScore W1603736948C2778938233 @default.
• W1603736948 hasConceptScore W1603736948C2779110517 @default.
• W1603736948 hasConceptScore W1603736948C2779530757 @default.
• W1603736948 hasConceptScore W1603736948C2781047461 @default.
• W1603736948 hasConceptScore W1603736948C33923547 @default.
• W1603736948 hasConceptScore W1603736948C41008148 @default.
• W1603736948 hasConceptScore W1603736948C54355233 @default.
• W1603736948 hasConceptScore W1603736948C60644358 @default.
• W1603736948 hasConceptScore W1603736948C86803240 @default.
• W1603736948 hasConceptScore W1603736948C90673727 @default.
• W1603736948 hasConceptScore W1603736948C98045186 @default.
• W1603736948 hasLocation W16037369481 @default.
• W1603736948 hasOpenAccess W1603736948 @default.
• W1603736948 hasPrimaryLocation W16037369481 @default.
• W1603736948 hasRelatedWork W1480442169 @default.
• W1603736948 hasRelatedWork W1506402450 @default.
• W1603736948 hasRelatedWork W1581064108 @default.
• W1603736948 hasRelatedWork W2019689548 @default.
• W1603736948 hasRelatedWork W2046032587 @default.
• W1603736948 hasRelatedWork W2061443652 @default.
• W1603736948 hasRelatedWork W2184768034 @default.
• W1603736948 hasRelatedWork W2255501947 @default.
• W1603736948 hasRelatedWork W2271649551 @default.
• W1603736948 hasRelatedWork W2606895750 @default.
• W1603736948 hasRelatedWork W2742402667 @default.
• W1603736948 hasRelatedWork W2804411455 @default.
• W1603736948 hasRelatedWork W3212077014 @default.
• W1603736948 hasRelatedWork W6902157 @default.
• W1603736948 hasRelatedWork W813939362 @default.
• W1603736948 hasRelatedWork W835274437 @default.
• W1603736948 hasRelatedWork W1953694922 @default.
• W1603736948 hasRelatedWork W2560830297 @default.
• W1603736948 hasRelatedWork W3137438433 @default.
• W1603736948 hasRelatedWork W81935000 @default.
• W1603736948 isParatext "false" @default.
• W1603736948 isRetracted "false" @default.

• next