TESSEE – Tool for Early Stem Cells Economic Evaluation

Bandeiras, Cátia; Finkelstein, Stan N.; Ferreira, Frederico Castelo

doi:10.1007/978-3-030-31635-8_233

Cited by 1 publication

(7 citation statements)

References 21 publications

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“…A large number of simulation runs are then performed by randomly sampling values from the established probability distributions, with the samples of each run being used to determine their respective outputs. This results in the generation of output probability distributions, allowing not only to identify the range of possible outcomes but also to analyze the variability of each output and the probability of exceeding a certain critical threshold [ 17 , 31 , 32 ].…”

Section: Characterization Of Bioprocess Modelsmentioning

confidence: 99%

“…Aside from depending directly on the manufacturing structure of the bioprocess itself, the value of the FCI can be influenced by several factors, such as the ratio between open and closed cleanroom areas, the choice between automated versus manual processing and the use of disposable or nondisposable process platforms [ 33 ]. To determine the total initial investment involved in the establishment of a manufacturing facility for stem cell processing, two models can be implemented: a cost-per-area-model or a Lang factor model [ 32 ]. The first model consists in defining the cleanroom area of a facility along with its noncleanroom area, summing both areas multiplied by their respective price-per-square-meter (or another unit of area) and then adding the total equipment acquisition cost [ 33 ].…”

Section: Bioprocess Economicsmentioning

confidence: 99%

“…The first model consists in defining the cleanroom area of a facility along with its noncleanroom area, summing both areas multiplied by their respective price-per-square-meter (or another unit of area) and then adding the total equipment acquisition cost [ 33 ]. The Lang factor model determines the FCI by multiplying the total equipment acquisition cost by a cost factor, which should be based on the relationship between the FCI and equipment acquisition cost observed for past projects of a similar nature [ 32 , 33 ].…”

Section: Bioprocess Economicsmentioning

confidence: 99%

“…Generally speaking, the CoG is expressed in relation to a single therapeutic dose. Direct costs can be further broken down into three categories, namely consumable, reagent and quality control costs [ 32 ]. Consumables include all disposable lab equipment, such as single-use vessels, serological pipettes, gloves, etc.…”

Section: Bioprocess Economicsmentioning

confidence: 99%

“…Indirect costs can broadly be subdivided into infrastructure and labor costs [ 32 ]. Infrastructure costs cover a wide variety of expenses, including facility and equipment depreciation.…”

Section: Bioprocess Economicsmentioning

confidence: 99%

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Bioprocess Economic Modeling: Decision Support Tools for the Development of Stem Cell Therapy Products

et al. 2022

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Over recent years, the field of cell and gene therapy has witnessed rapid growth due to the demonstrated benefits of using living cells as therapeutic agents in a broad range of clinical studies and trials. Bioprocess economic models (BEMs) are fundamental tools for guiding decision-making in bioprocess design, being capable of supporting process optimization and helping to reduce production costs. These tools are particularly important when it comes to guiding manufacturing decisions and increasing the likelihood of market acceptance of cell-based therapies, which are often cost-prohibitive because of high resource and quality control costs. Not only this, but the inherent biological variability of their underlying bioprocesses makes them particularly susceptible to unforeseen costs arising from failed or delayed production batches. The present work reviews important concepts concerning the development of bioprocesses for stem cell therapy products and highlights the valuable role which BEMs can play in this endeavor. Additionally, some theoretical concepts relevant to the building and structuring of BEMs are explored. Finally, a comprehensive review of the existent BEMs so far reported in the scientific literature for stem cell-related bioprocesses is provided to showcase their potential usefulness.

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Section: Characterization Of Bioprocess Modelsmentioning

confidence: 99%

Section: Bioprocess Economicsmentioning

confidence: 99%

Section: Bioprocess Economicsmentioning

confidence: 99%

Section: Bioprocess Economicsmentioning

confidence: 99%

“…Indirect costs can broadly be subdivided into infrastructure and labor costs [ 32 ]. Infrastructure costs cover a wide variety of expenses, including facility and equipment depreciation.…”

Section: Bioprocess Economicsmentioning

confidence: 99%

See 3 more Smart Citations