Cell therapy manufacturing value systems and cost analysis
Year: 2013
Type: dissertation
Abstract: Cell Therapies are promising clinical instruments with significant therapeutic potential and\ncommercial promise. However, the industry engaged in their commercial and clinical\ndevelopment faces significant financial, technical, regulatory and market challenges.\nThese challenges are compounded by an understanding gap in the cell therapy industry.\nCommercial failures and financial difficulties have forced the industry to address the need to\nprovide value and estimate and control costs early in the development timeline. The problem\nis that this issue is not being systematically or thoroughly addressed in the academic\ncommunity while they pursue potential future treatments. Articles that highlight the need to\nunderstand costs and value are appearing with increasing frequency highlighting a growing\nconsensus that work needs to be carried out in this area. However examples of models and\ntools to predict or estimate or even calculate costs in developing and producing a product do\nnot exist in the literature.\nThis work consists of three parts. Part one entails a new model of the characteristics observed\nin cell therapy new product development. This model is an evolution of an activity based\ndependency structure matrix (DSM). Result from the model suggests that some favoured\ndevelopment strategies (such as applying for an orphan indication status) provide less\nfinancial benefit than is commonly expected. The ability to scale manufacturing levels\nbetween clinical trial phases is also a pressing problem.\n3\nPart two presents a model to predict the cost of manufacturing and delivering a cell therapy\nproduct. This cost of good supplied (COGS) model combines both rules and predictive\nactivity based costing across multiple manufacturing platforms, cell types and supply chain\nconfigurations. This model highlights the significant cost burden of validating both single\nand, more markedly, multiple sites of manufacture. The model also examines the potential\nfor economies of scale when using different production technology in the manufacture of\nhuman Mesenchymal Stem Cells.\nBased in part on the results and knowledge gleaned in parts one and two, part three outlines\nthe development of a novel, scalable expansion system developed to enable lower cost,\ncontrolled manufacture of adherent cell populations. While still at an early stage of\ndevelopment the technology has demonstrated the ability to maintain cells in a high rate of\ngrowth for a longer period than traditional culture techniques. This allows for the creation of\na manufacturing technology with a higher expansion ratio than manufacturing systems on the\nmarket today.
Author: Mark McCall
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W2237013461