Techno-Economic Analysis of Automated iPSC Production

Abstract

Induced pluripotent stem cells (iPSC) open up the unique perspective of manufacturing cell products for drug development and regenerative medicine in tissue-, disease- and patient-specific forms. iPSC can be multiplied almost without restriction and differentiated into cell types of all organs. The basis for clinical use of iPSC is a high number of cells (approximately 7 × 107 cells per treatment), which must be produced cost-effectively while maintaining reproducible and high quality. Compared to manual cell production, the automation of cell production offers a unique chance of reliable reproducibility of cells in addition to cost reduction and increased throughput. StemCellFactory is a prototype for a fully automated production of iPSC. However, in addition to the already tested functionality of the system, it must be shown that this automation brings necessary economic advantages. This paper presents that fully automated stem cell production offers economic advantages in addition to increased throughput and better quality. First, biological and technological basics for a fully automated production of iPSC are presented. Second, the basics for profitability calculation are presented. Third, profitability of both manual and automated production are calculated. Finally, different scenarios effecting the profitability of manual and automated production are compared.

From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product

“…Especially with constantly rising personnel wages, an automated production will become even more cost-effective from an economic perspective. In the complex production of iPS cells, personnel costs account for nearly 60% of total manufacturing costs, with estimably 42% more manual production costs than in automated production (30). These costs are comparable to a sophisticated TEP product like the N-TEC, which ranges from 17,000-20,000 e per product with frequent manual interventions and produced in an academic setting.…”

“…These costs are comparable to a sophisticated TEP product like the N-TEC, which ranges from 17,000-20,000 e per product with frequent manual interventions and produced in an academic setting. The investment for automated iPS production is estimated to be about 1,000,000 e, whereas the investment for the automated TEP production plant in total is estimated 1,500,000 e, with additional operational resources as described elsewhere (30). Even though the initial payback period a TEP-facility might also be longer, than those of a cell production line, with an increasing TEP market availability, positive cash flow could be achievable within the first 3 years of market acceptance.…”

Cell Cluster Sorting in Automated Differentiation of Patient-specific Induced Pluripotent Stem Cells Towards Blood Cells

“…iPS cells offer unprecedented opportunities for disease modeling, drug screening, regenerative and personalized medicine ( Rowe and Daley, 2019 ). However, the processes of iPS cell reprogramming, maintenance, and differentiation are costly and require constant supervision and cell quality assessment by highly trained personnel ( Chen et al, 2014 ; Niessing et al, 2021 ). Techniques for manual iPS cell handling continue to advance but generating iPS cells of high quality at large scale and in compliance with Good Manufacturing Practice (GMP) still remains a challenge ( Baghbaderani et al, 2015 ; Rivera et al, 2020 ).…”

“…Traditional manual handling of iPS cells relies mostly on the expertise of the operator and inevitable inter-technician variabilities affect iPS cell growth and quality. Moreover, manual handling introduces financial and temporal obstacles that limit large scale iPS cell application ( Soares et al, 2014 ; Niessing et al, 2021 ).…”

Fully Automated Cultivation of Adipose-Derived Stem Cells in the StemCellDiscovery—A Robotic Laboratory for Small-Scale, High-Throughput Cell Production Including Deep Learning-Based Confluence Estimation

“…Indeed, it is well understood that many aspects of the medicine of the future will only become feasible through the aid of automation-ranging from automated analysis of complex data for precision medicine, and healthcare robotics in surgery and care, to automated production and intelligent supply chains for advanced therapies [1,2]. This is particularly true for cell-based personalized therapies that require automation to make products affordable and accessible [3,4]. Whether the application is in personalized drug development or for autologous cell therapies, the expansion of patient-derived cells Processes 2021, 9, 575 2 of 19 is labor-intensive and characterized by a high batch-to-batch variability.…”