Uncovering the potential of ultra scale-down tools to enable cost-effective “Quality by Design”

Masri, Fernanda

doi:10.18609/cgti.2016.057

Cited by 4 publications

(3 citation statements)

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“…The intricate relationship between the product and process in cell therapies poses challenges, including exposure to various stresses during processing, which can result in DNA damage, genomic alterations, physiological changes, cell death, and physical damage. Additionally, the need for robust processes to ensure the quality and integrity of the cells throughout processing is crucial for the successful commercialization of cell-based therapies [6].…”

Section: Challenges Faced By Existing Cell-based Therapiesmentioning

confidence: 99%

Ultra-Scale Down Models: A Review

2024

IJSREM

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Ultra scale-down (USD) models have emerged as indispensable tools, addressing challenges in process development and optimization. This review delves into the transformative potential of Ultra Scale-Down (USD) models, exploring their applications, benefits, limitations, and future directions. As industries deal with more complicated manufacturing processes, the integration of USD models into development pipelines becomes crucial. This approach holds the potential to reduce timeframes, cut costs, and enhance the overall efficiency of various processes, contributing to advancements across diverse fields. Envision transforming intricate manufacturing not through colossal machinery but by harnessing the capabilities of tiny vials and microfluidic chips. This encapsulates the essence of ultra scale-down (USD), an innovative approach that downsizes the landscape of process development. Essentially, USD duplicates pivotal elements of large-scale processes on a considerably smaller scale, typically employing milliliter-sized volumes. While USD is still advancing, and its potential to transform process development is evident. Embracing miniaturization, researchers and engineers unleash efficiency, cut costs, and hasten the launch of innovative products. Keywords: Ultra Scale-Down (USD) models, Downstream processing, Cell-based therapies, Early-stage optimization, Real-time applications, Personalized medicine

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Section: Challenges Faced By Existing Cell-based Therapiesmentioning

confidence: 99%

Ultra-Scale Down Models: A Review

2024

IJSREM

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“…Easily scalable separation techniques will become more and more important as regenerative medicine develops, and particularly as allogeneic therapies become more common. Moreover, the development of bench-scale technologies that better mimic the full scale will be paramount to the rapid development of robust downstream processes and allow cost-effective process optimisation [5]. Many of the currently applied downstream processing techniques, whilst highly effective in terms of cell isolation, are limited by the need to label target cells to effect isolation and by a limited maximal scale of operation.…”

Section: Scalabilitymentioning

confidence: 99%

Challenges and advances in scale-up of label-free downstream processing for allogeneic cell therapies

Masri¹,

Hoeve

Sousa

et al. 2017

Cell Gene Therapy Insights

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“…These allow the use of small quantities of material to better understand the impact on the sample during biomanufacturing in a time-effective manner. These techniques aim to mimic full-scale process behaviour by using lab-scale devices and methodologies (Rayat ACME et al, 2016;Masri, 2016). Therefore, establishing a scale-down methodology for flocculation and centrifugation will benefit the development and optimisation of a robust large-scale primary recovery.…”

Section: Introductionmentioning

confidence: 99%