Cell Therapy: Early Process Development and Optimization of the Manufacturing Process are Critical to Ensure Viability of the Product, Quality, Consistency and Cost Efficiency

2015 ◽  
Vol 21 (1) ◽  
Author(s):  
Ohad Karnieli
Keyword(s):  
Cell Therapy ◽  
Cost Efficiency ◽  
Process Development ◽  
Scale Up ◽  
Three Dimensional ◽  
Evolutionary Development ◽  
Cell Therapies ◽  
Cost Drivers ◽  
Living Things ◽  
The Cost

In recent years cell therapies have evolved and matured, moving from academia to industry. Scale up of a process is the natural path of any product evolutionary development and maturation, this process not only allows higher manufacturing capacity to meet demands but rather to increases the yields and reduces cost of goods. Cells are living things that react to the environment and conditions in which they grow, therefore process changes should be done as early as possible. The traditional 2D culturing systems can be truly up scaled, therefore there is a need to advance to bioreactors that will influence the product. Additionally, in order to make cell therapy a viable one, the cost of manufacturing is critical. Cost drivers such as media, serum, footprint, human resource and infrastructure must be optimized without changing the cells critical quality attributes. The paper analyze the main cost drivers on the cost of goods and is based on the experience of cell manufacturing in both traditional 2D and three dimensional (3D) bioreactor systems produced in Pluristem therapeutics GMP site. Furthermore, the paper discussed possible process development steps to insure cost efficiency emphasizing the need and benefit of early process development investment.   

scholarly journals A REPORT ON STEM CELLS AND THEIR APPLICATIONS

2020 ◽  
pp. 1-2
Author(s):  
Shantha A R
Keyword(s):  
Stem Cells ◽  
Stem Cell ◽  
Cell Therapy ◽  
Stem Cell Therapy ◽  
Building Blocks ◽  
Cell Types ◽  
The Body ◽  
Cell Therapies ◽  
Undifferentiated Cells ◽  
The Cost

Stem cells are the building blocks of life. They have remarkable potential to regenerate and develop into many different cell types in the body during early life and growth. They are also a class of undifferentiated cells that are able to be differentiated into specialized cells types. Stem cells are characterized by certain features such as totipotency, pluripotency, multipotency, oligopotent and unipotency. The history of stem cell research had an embryonic beginning in the mid 1800s with the discovery that few cells could generate other cells. In the 1900s the first stem cells were discovered when it was found that cells generate blood cells. Nowadays, stem cell therapy is under research and till now, a very few stem cell therapies have been regarded as safe and successful. It is also found that stem cell therapy cast a number of side effects too. The cost of the procedure too is expensive and is not easily affordable.

scholarly journals C-STEM: ENGINEERING NICHE-LIKE MICRO-COMPARTMENTS FOR OPTIMAL AND SCALE-INDEPENDENT EXPANSION OF HUMAN PLURIPOTENT STEM CELLS IN BIOREACTORS

2021 ◽  
Author(s):  
Philippe J.R. Cohen ◽  
Elisa Luquet ◽  
Justine Pletenka ◽  
Andrea Leonard ◽  
Elise Warter ◽  
...  
Keyword(s):  
Stem Cells ◽  
Pluripotent Stem Cells ◽  
Large Scale ◽  
Scale Up ◽  
Three Dimensional ◽  
Culture Conditions ◽  
Human Pluripotent Stem Cells ◽  
Cell Therapies ◽  
Cellular Source

Human pluripotent stem cells (hPSCs) have emerged as the most promising cellular source for cell therapies. To overcome scale up limitations of classical 2D culture systems, suspension cultures have been developed to meet the need of large-scale culture in regenerative medicine. Despite constant improvements, current protocols relying on the generation of micro-carriers or cell aggregates only achieve moderate amplification performance. Here, guided by reports showing that hPSCs can self-organize in vitro into cysts reminiscent of the epiblast stage in embryo development, we developed a physio-mimetic approach for hPSC culture. We engineered stem cell niche microenvironments inside microfluidics-assisted core-shell microcapsules. We demonstrate that lumenized three-dimensional colonies maximize viability and expansion rates while maintaining pluripotency. By optimizing capsule size and culture conditions, we scale-up this method to industrial scale stirred tank bioreactors and achieve an unprecedented hPSC amplification rate of 282-fold in 6.5 days.

scholarly journals High-throughput 3D screening for differentiation of hPSC-derived cell therapy candidates

2020 ◽  
Vol 6 (32) ◽  
pp. eaaz1457
Author(s):  
Riya Muckom ◽  
Xiaoping Bao ◽  
Eric Tran ◽  
Evelyn Chen ◽  
Abirami Murugappan ◽  
...  
Keyword(s):  
Cell Therapy ◽  
High Throughput ◽  
System Development ◽  
Three Dimensional ◽  
3D Culture ◽  
3D Cell Culture ◽  
Culture Conditions ◽  
Nervous System Development ◽  
Oligodendrocyte Progenitor Cells ◽  
Cell Therapies

The emergence of several cell therapy candidates in the clinic is an encouraging sign for human diseases/disorders that currently have no effective treatment; however, scalable production of these cell therapies has become a bottleneck. To overcome this barrier, three-dimensional (3D) cell culture strategies have been considered for enhanced cell production. Here, we demonstrate a high-throughput 3D culture platform used to systematically screen 1200 culture conditions with varying doses, durations, dynamics, and combinations of signaling cues to derive oligodendrocyte progenitor cells and midbrain dopaminergic neurons from human pluripotent stem cells (hPSCs). Statistical models of the robust dataset reveal previously unidentified patterns about cell competence to Wnt, retinoic acid, and sonic hedgehog signals, and their interactions, which may offer insights into the combinatorial roles these signals play in human central nervous system development. These insights can be harnessed to optimize production of hPSC-derived cell replacement therapies for a range of neurological indications.

scholarly journals Evidence of the Cost-Efficiency of Scale as seen in Polio Vaccination and Surveillance Costs

2019 ◽  
Author(s):  
Brittany L. Hagedorn ◽  
Laina D. Mercer ◽  
Guillaume Chabot-Couture
Keyword(s):  
Cost Efficiency ◽  
Disease Surveillance ◽  
Economies Of Scale ◽  
Scale Up ◽  
Polio Eradication ◽  
Lessons Learned ◽  
Fixed Costs ◽  
Polio Vaccination ◽  
Program Costs ◽  
The Cost

AbstractThis analysis examined how polio program costs vary with scale for vaccination and disease surveillance, based on historical budget data published by the Global Polio Eradication Initiative (GPEI) from 2005 to 2018. We applied a linear mixed effects regression model in order to understand the cost structure of the historical GPEI budgets, with the goal that lessons learned from polio may be extended to other global disease elimination programs. Our findings demonstrate that there are economies of scale for vaccine delivery operations and for disease surveillance, which means that larger programs can leverage fixed costs and achieve better cost-efficiency as they scale. This finding should enable decision makers to create more reliable budgets, which support fundraising and optimal resource allocation. They also provide insight into how cost effectiveness changes as programs scale up during progressive disease control and elimination, as well as what level of resources are needed to sustain a program that is scaling back post-eradication and through to certification.

A generalized fuzzy cost efficiency model

2020 ◽  
Vol 54 (6) ◽  
pp. 1775-1791
Author(s):  
Nazila Aghayi ◽  
Samira Salehpour
Keyword(s):  
Cost Efficiency ◽  
Minimum Cost ◽  
Extensive Literature ◽  
Data Envelopment ◽  
Fuzzy Environment ◽  
Decision Making Unit ◽  
Production Possibility Set ◽  
Fuzzy Cost ◽  
The Cost ◽  
Generalized Cost

The concept of cost efficiency has become tremendously popular in data envelopment analysis (DEA) as it serves to assess a decision-making unit (DMU) in terms of producing minimum-cost outputs. A large variety of precise and imprecise models have been put forward to measure cost efficiency for the DMUs which have a role in constructing the production possibility set; yet, there’s not an extensive literature on the cost efficiency (CE) measurement for sample DMUs (SDMUs). In an effort to remedy the shortcomings of current models, herein is introduced a generalized cost efficiency model that is capable of operating in a fuzzy environment-involving different types of fuzzy numbers-while preserving the Farrell’s decomposition of cost efficiency. Moreover, to the best of our knowledge, the present paper is the first to measure cost efficiency by using vectors. Ultimately, a useful example is provided to confirm the applicability of the proposed methods.

Diagnostic System of Gravitational Solid Flow Based on Weight and Accelerometer Signal Analysis Using Wireless Data Transmission Technology

2012 ◽  
Vol 17 (4) ◽  
pp. 319-326 ◽  
Author(s):  
Zbigniew Chaniecki ◽  
Krzysztof Grudzień ◽  
Tomasz Jaworski ◽  
Grzegorz Rybak ◽  
Andrzej Romanowski ◽  
...  
Keyword(s):  
Signal Analysis ◽  
Scale Up ◽  
Three Dimensional ◽  
Diagnostic System ◽  
Wireless Data ◽  
Stick Slip ◽  
Wireless Data Transmission ◽  
Accelerometer Signal ◽  
Flow Investigation ◽  
Material Information

Abstract The paper presents results of the scale-up silo flow investigation in based on accelerometer signal analysis and Wi-Fi transmission, performed in distributed laboratory environment. Prepared, by the authors, a set of 8 accelerometers allows to measure a three-dimensional acceleration vector. The accelerometers were located outside silo, on its perimeter. The accelerometers signal changes allowed to analyze dynamic behavior of solid (vibrations/pulsations) at silo wall during discharging process. These dynamic effects are caused by stick-slip friction between the wall and the granular material. Information about the material pulsations and vibrations is crucial for monitoring the interaction between silo construction and particle during flow. Additionally such spatial position of accelerometers sensor allowed to collect information about nonsymmetrical flow inside silo.

Acoustic and Photoacoustic Inspection of Through-Silicon Vias in the GHz-Frequency Band

2017 ◽  
Author(s):  
Sebastian Brand ◽  
Michael Kögel ◽  
Frank Altmann ◽  
Ingrid DeWolf ◽  
Ahmad Khaled ◽  
...  
Keyword(s):  
Quality Assessment ◽  
Frequency Band ◽  
Process Development ◽  
Three Dimensional ◽  
Non Destructive Testing ◽  
Destructive Testing ◽  
Vertical Interconnection ◽  
Testing Techniques ◽  
Silicon Vias ◽  
Non Destructive

Abstract Through Silicon Via (TSV) is the most promising technology for vertical interconnection in novel three-dimensional chip architectures. Reliability and quality assessment necessary for process development and manufacturing require appropriate non-destructive testing techniques to detect cracks and delamination defects with sufficient penetration and imaging capabilities. The current paper presents the application of two acoustically based methods operating in the GHz-frequency band for the assessment of the integrity of TSV structures.

ANALISIS PENGARUH BIAYA OPERASIONAL PADA PERUSAHAAN PENERBANGAN NASIONAL

2017 ◽  
Vol 1 (2) ◽  
pp. 81-107
Author(s):  
Dheny Biantara
Keyword(s):  
Value Chain ◽  
Cost Efficiency ◽  
Cost Reduction ◽  
Cost Leadership ◽  
Oil Pricing ◽  
The Cost ◽  
Operation Flexibility ◽  
Airline Maintenance

Summarized Indonesian airline executive views on the reason for the cost problem in mayor airline andon the potential areas and measures of cost reduction in airline operation. Present an introductionsurvey where 3 executives from 3 Indonesian airlines were respondent. In the executive opinion the costproblem in mayor Indonesian airline is primarily due to fuel and oil pricing and money currency. Of thevarious function in airline maintenance was seen as least cost efficiency, whereas flight operation wasseen as an area with most potential for cost reduction. Indonesian airline had made route and fleetchanges after the beginning of 2011 to reduce cost, concludes from the analisys result havingprivatization would be an important step towards more efficient airline operation. Flexibility fromIndonesian airline regulatory would be very much welcome and the value chain concept to improveIndonesian airline having competitive adventage and cost leadership differentiation.

Constructive Optimisation of the Propeller Type Mixing Devices Using the Virtual and Rapid Prototyping

2017 ◽  
Vol 68 (3) ◽  
pp. 453-458 ◽  
Author(s):  
Daniel Besnea ◽  
Alina Spanu ◽  
Iuliana Marlena Prodea ◽  
Gheorghita Tomescu ◽  
Iolanda Constanta Panait
Keyword(s):  
Rapid Prototyping ◽  
Low Cost ◽  
Scale Up ◽  
Three Dimensional ◽  
Rapid Identification ◽  
Multidisciplinary Optimization ◽  
External Diameter ◽  
Process Industries ◽  
Parametric Cad ◽  
Shaft Torque

The paper points out the advantages of rapid prototyping for improving the performances/constructive optimization of mixing devices used in process industries, here exemplified to propeller types ones. The multidisciplinary optimization of the propeller profile affords its design using parametric CAD methods. Starting from the mathematical curve equations proposed for the blade profile, it was determined its three-dimensional virtual model. The challenge has been focused on the variation of propeller pitch and external diameter. Three dimensional ranges were manufactured using the additive manufacturing process with Marker Boot 3D printer. The mixing performances were tested on the mixing equipment measuring the minimum rotational speed and the correspondent shaft torque for complete suspension achieved for each of the three models. The virtual and rapid prototyping method is newly proposed by the authors to obtain the basic data for scale up of the mixing systems, in the case of flexible production (of low quantities), in which both the nature and concentration of the constituents in the final product varies often. It is an efficient and low cost method for the rapid identification of the optimal mixing device configuration, which contributes to the costs reduction and to the growing of the output.

A seven year plan for upgrading the 200.000 p.e. treatment plant of Uppsala, Sweden

1994 ◽  
Vol 29 (12) ◽  
pp. 117-127
Author(s):  
Jan Erik Lind ◽  
Ernst Olof Swedling
Keyword(s):  
Cost Efficiency ◽  
Sewage Treatment ◽  
Sewage Treatment Plant ◽  
Treatment Plant ◽  
Working Environment ◽  
Regional Environment ◽  
Nitrogen Reduction ◽  
Total Investment ◽  
Close Cooperation ◽  
The Cost

The sewage treatment plant of Uppsala was originally built in 1946 and has since then been extended and upgraded several times up to 1972 when the last major upgrading was completed. In 1987 it was decided to renew the treatment plant for at least another 20-30 years of operation and to upgrade the biological process to include nitrogen reduction. A 7 year plan covering some 18 items with a total investment cost of approximately 120 MSEK was set in action during 1987. The aim was to raise the cost efficiency by introducing modern techniques, new machinery, a better working environment and a better understanding of the processes used. The need to keep the plant in operation during reconstruction work has caused difficulties, delays and unforseen costs but a close cooperation between all parties concerned (operators, contractors, engineers and the regional environment administration) has solved most of the problems. Experiences so far include an improved effluent quality, a better cost efficiency, a healthier and more engaged operating staff. A research team has been engaged to develop and introduce a nitrogen reduction scheme in the activated sludge process. This has been a challenging and fruitful experience.

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