Matches in SemOpenAlex for { <https://semopenalex.org/work/W2962358274> ?p ?o ?g. }
Showing items 1 to 61 of
61
with 100 items per page.
- W2962358274 abstract "Cell therapy products offer the potential for treatment and possibly cure of a number of indications, such as cancer, diabetes and heart disease. However, a number of economic, regulatory, logistical and technical challenges need to be addressed so as to achieve successful commercialisation of cell therapy products. With more cell therapy products reaching commercial stage, there is an increased interest in developing and evaluating novel manufacturing strategies to enhance cost-effectiveness while accommodating the unique features of cell therapy products. This thesis aims to develop and apply advanced decisional tools so as to provide an integrated approach that offers valuable insights to some of the dominant challenges faced by cell therapy developers. The decisional tools developed in this thesis comprise the following models tailored to cell therapy products: a technology-specific detailed factorial method for fixed capital investment (FCI) estimation, a process economics model for computing cost of goods (COG), brute force optimization, a multi-attribute decision making model, a robustness analysis model and a risk-adjusted net present value model. A key novel contribution is the detailed factorial methodology for estimating FCI and footprint for bespoke cell therapy facilities that accounts for technology-specific factors for key manufacturing platforms as well as the implications of single-use technologies and open versus closed operations. This is used to derive benchmark values for short-cut Lang factors for typical cell therapy facilities according to the technologies and commercialisation scenario selected. A set of industrially-relevant case studies is presented for topical cell therapies, namely mesenchymal stem cell (MSC) therapies and chimeric antigen receptor (CAR) T-cell therapies. The case studies explored different aspects of the manufacturing strategy of 5 cell therapy products such as optimal technology selection, process robustness, performance targets for successful commercialisation, fixed capital investment requirement, the cost benefits of allogeneic cell therapy products with respect to autologous cell therapy products and the effect of decentralised multi-site manufacture of autologous products. In particular, the MSC case study provides a more holistic approach to evaluating different technologies that considers both financial and operational features. The CAR T-cell case study provides the first in-depth economic analysis and set of insights at both the technology level and an enterprise’s facility configuration level. The work in the thesis illustrates how the decisional tools developed can facilitate the design of cost-effective manufacturing strategies for cell therapy products." @default.
- W2962358274 created "2019-07-23" @default.
- W2962358274 creator A5021730111 @default.
- W2962358274 creator A5066501376 @default.
- W2962358274 date "2019-01-28" @default.
- W2962358274 modified "2023-09-26" @default.
- W2962358274 title "Decisional tools for enabling successful manufacture and commercialisation of cell therapy products" @default.
- W2962358274 hasPublicationYear "2019" @default.
- W2962358274 type Work @default.
- W2962358274 sameAs 2962358274 @default.
- W2962358274 citedByCount "0" @default.
- W2962358274 crossrefType "dissertation" @default.
- W2962358274 hasAuthorship W2962358274A5021730111 @default.
- W2962358274 hasAuthorship W2962358274A5066501376 @default.
- W2962358274 hasConcept C10882517 @default.
- W2962358274 hasConcept C112698675 @default.
- W2962358274 hasConcept C112930515 @default.
- W2962358274 hasConcept C127413603 @default.
- W2962358274 hasConcept C144133560 @default.
- W2962358274 hasConcept C28328180 @default.
- W2962358274 hasConcept C41008148 @default.
- W2962358274 hasConcept C44210515 @default.
- W2962358274 hasConcept C54355233 @default.
- W2962358274 hasConcept C86803240 @default.
- W2962358274 hasConceptScore W2962358274C10882517 @default.
- W2962358274 hasConceptScore W2962358274C112698675 @default.
- W2962358274 hasConceptScore W2962358274C112930515 @default.
- W2962358274 hasConceptScore W2962358274C127413603 @default.
- W2962358274 hasConceptScore W2962358274C144133560 @default.
- W2962358274 hasConceptScore W2962358274C28328180 @default.
- W2962358274 hasConceptScore W2962358274C41008148 @default.
- W2962358274 hasConceptScore W2962358274C44210515 @default.
- W2962358274 hasConceptScore W2962358274C54355233 @default.
- W2962358274 hasConceptScore W2962358274C86803240 @default.
- W2962358274 hasLocation W29623582741 @default.
- W2962358274 hasOpenAccess W2962358274 @default.
- W2962358274 hasPrimaryLocation W29623582741 @default.
- W2962358274 hasRelatedWork W1535176758 @default.
- W2962358274 hasRelatedWork W185958167 @default.
- W2962358274 hasRelatedWork W1965997255 @default.
- W2962358274 hasRelatedWork W1994826548 @default.
- W2962358274 hasRelatedWork W2292182851 @default.
- W2962358274 hasRelatedWork W2305427950 @default.
- W2962358274 hasRelatedWork W2332621685 @default.
- W2962358274 hasRelatedWork W2346675976 @default.
- W2962358274 hasRelatedWork W2913204380 @default.
- W2962358274 hasRelatedWork W2964912682 @default.
- W2962358274 hasRelatedWork W3025742750 @default.
- W2962358274 hasRelatedWork W3028536485 @default.
- W2962358274 hasRelatedWork W3039488754 @default.
- W2962358274 hasRelatedWork W3058648909 @default.
- W2962358274 hasRelatedWork W3158773595 @default.
- W2962358274 hasRelatedWork W418709939 @default.
- W2962358274 hasRelatedWork W565546351 @default.
- W2962358274 hasRelatedWork W64235813 @default.
- W2962358274 hasRelatedWork W90826835 @default.
- W2962358274 hasRelatedWork W2240829809 @default.
- W2962358274 isParatext "false" @default.
- W2962358274 isRetracted "false" @default.
- W2962358274 magId "2962358274" @default.
- W2962358274 workType "dissertation" @default.