3 implications of the innovative automated cell culture systems we should recognize

As a complex and still maturing industry, the manufacturing of advanced therapies continues to face significant challenges — most visibly reflected in treatment prices that can reach six-figure sums. Scaling upstream bioprocessing is typically associated with automated cell culture systems as a solution to long-standing manufacturing bottlenecks. However, the question of whether early automation alone represents the optimal response to capacity constraints remains open.

From time- and cost-efficiency to reliability and robustness, automation of advanced therapy manufacturing and automated cell cultures will result in various changes with the consequences that are still not understood entirely. © Green Elephant Biotech.

The latest class of medical interventions – namely, cell and gene therapies (CGTs), is enabled by advanced molecular tools that allow the introduction, modification, or removal of genetic material within a patient’s cells. While the scientific foundations of CGTs have been established over several decades, industrial-scale manufacturing capabilities are only now beginning to catch up (1).

Spanning applications from stem cell therapies to in vivo gene editing and tissue engineering, CGTs hold therapeutic promise for approximately 400 million individuals worldwide, particularly those affected by rare disorders (2). At the same time, biotechnology facilities reported an average batch failure rate of once every 40.6 months as early as 2008, highlighting the fragility of early manufacturing workflows (3).

Despite more than a decade of progress since those findings, labor shortages, contamination risks, and operator-dependent errors remain among the most prominent bottlenecks in CGT manufacturing, collectively contributing to high production costs. Against this backdrop, automated cell culture systems and artificial intelligence (AI) are increasingly viewed as credible tools for transforming upstream bioprocessing.

Under ideal conditions of partial or full automation, labor demands for manually intensive tasks could be reduced by up to 16-fold, ecological footprint by 30-fold, and goods costs by more than 50% (4). This entry therefore examines both the opportunities and the more contentious implications of automated cell culture as part of the upstream bioprocessing landscape.

Automated cell culture systems will influence the type of skills required from the CGT personnel

The shortage of skilled labor is widely recognized as a critical contributor to manufacturing capacity constraints, with more than 50% of biopharmaceutical manufacturers reporting difficulty in recruiting qualified personnel (2). This shortage directly affects cost structures, as labor-related activities — including facility operations, quality control, and quality assurance — account for approximately 45-48% of total manufacturing costs (5).

In addition to supply chain and regulatory pressures, conventional cell culture workflows require extensive hands-on involvement, including cell inoculation, feeding, sampling, and harvesting. While automation reduces dependence on manual intervention, adoption has progressed more slowly for adherent cell systems (6). Unlike suspension cultures, anchorage-dependent cells require specific surface properties and are less tolerant of structural changes, complicating automation strategies.

Automation advances in chimeric antigen receptor (CAR)-T cell manufacturing, for instance, were predicted to reduce both handling time and resource consumption. Empirical evaluation of an automated approach within an existing CAR-T workflow demonstrated a 3-fold reduction in manufacturing time and a corresponding 35% decrease in production costs, offering quantitative support for the value of automation (5).

Looking ahead, closed systems capable of monitoring and autonomously adjusting growth parameters such as temperature and pH are expected to influence not only facility operations but workforce composition. Automation is projected to require CGT personnel to acquire up to 55% more digital competencies than currently needed, reducing but not eliminating the demand for skilled labor and personnel training (5).

Simplification and conscious adoption come hand-in-hand with realistic automated solutions

Despite its potential, premature adoption of automated cell culture systems and AI can introduce new challenges, often resurrecting manual handling and increasing variability rather than reducing it. While the biopharmaceutical sector reportedly invested approximately USD 3 billion in AI technologies in 2025, insufficient preparation and integration risk amplify operational complexity over time (7, 8).

From an operational excellence perspective, automation should be regarded as an enabling enhancement rather than a standalone solution. Standardization of personnel training, facility design, and material sourcing therefore remains essential. Cleanroom requirements in CGT manufacturing facilities illustrate this principle.

Maintaining high-grade cleanroom environments is resource-intensive, but closed automated cell culture systems can enable a shift from higher-grade A/B (ISO 5/6) environments to less expensive grade C/D (ISO 7/8). This transition has been shown to reduce environmental monitoring requirements by up to 65%, driven by lower energy and utility consumption (9, 10). However, even where financial resources are available, existing facility layouts and staffing models may limit immediate cost-of-goods indicators.

The takeaway is that workflow simplification and automation should not be pursued independently. Strategic, critical adoption — rather than trend-driven implementation — is key. Protocols that support scalability across development stages (e.g., from R&D to clinical translation), minimize variability, and reduce regulatory workload are best positioned to deliver long-term value.

Time and space are not the only aspects influenced by an automated cell culture

The ultimate objective of improving CGT manufacturing efficiency is to expand patient access to advanced therapies (6). A less widely discussed implication of automated cell culture is its potential to enable decentralized manufacturing models. With sufficiently robust and reproducible workflows, localized or point-of-care production could substantially reduce time-to-treatment and improve accessibility.

In centralized manufacturing facilities with limited flexibility, CGT production timelines typically range from 3 to 6 weeks — assuming no batch failure, contamination, or quality deviations occur. Transportation duration, mechanical stress during delivery, and logistical complexity further extend waiting periods for therapies that may be life-saving (9).

Although decentralization requires upfront capital investment comparable to that of automated cell culture infrastructure, successful implementation has demonstrated significant economic benefits. A CAR-T cell case study reported cost reductions of 80-90% using a point-of-care approach, achieving T cell activation and transduction within 6-12 days (11).

While many of these successes have been demonstrated primarily in autologous therapies, regulatory developments, such as the United Kingdom’s 2025 legislation permitting local production of personalized treatments, will provide a broader evaluation of decentralized manufacturing models (12). In this context, the role of automated cell culture systems extends well beyond facility optimization, actively shaping the future delivery of CGTs.

Automation in cell culture manufacturing is not a singular solution to the structural challenges facing the CGT industry, but it is a powerful lever when applied deliberately. Although the lack of fully-automated solutions for adherent cell cultures remains an obstacle, the potential benefits are fascinating: improved scalability, consistency, and accessibility of CGTs.

Various evidence points illustrate that automation delivers the greatest impact when it supports, but not replaces process simplification and uniformity. As CGTs continue to evolve clinically, the strategic integration of automated cell culture systems and AI will play a defining role in determining whether these therapies remain limited to small patient groups or become an every-day norm.

How do we contribute to the solution?

Green Elephant Biotech’s flagship technology, CellScrew®, exemplifies how workflow simplification and closed-system processing can be combined for anchorage-dependent cell cultivation. Designed to address both biological sensitivity and manufacturing variability, CellScrew® enables upstream bioprocessing without imposing rigid automation architectures. In comparative implementations, its use has been shown to reduce handling time by 30% and contamination risk — directly supporting capacity expansion and validated CGT production.

Discover more of CellScrew® ‘s design, performance, and application-specific use through the Green Elephant Biotech product documentation and application notes today.

References:

1. McCoy, R, Hasan, J, Ward, S, Gaddum, N, The necessity of automated manufacture for cell-based immunotherapies: a cost-based analysis (2020), Cell & Gene Therapy Insights 6, pp. 673-90. doi: 10.18609/cgti.2020.071.
2. The bottleneck that keeps patients waiting for access to affordable advanced therapies. (2023). Mira Sternstein, Green Elephant Biotech GmbH. Available: https://greenelephantbiotech.com/blog/the-bottleneck-that-keeps-patients-waiting-for-access-to-affordable-advanced-therapies/ (Accessed 21 January 2026).
3. Biotech Facilities Average a Batch Failure Every 40.6 Weeks. (2008). Eric S. Langer, BioProcess International. Available: https://www.bioprocessintl.com/bioanalytical-methods/biotech-facilities-average-a-batch-failure-every-40-6-weeks (Accessed 19 January 2026).
4. Why CGT manufacturers should automate the production process. (2024). Annabel Kartal-Allen, Manufacturing Chemist. Available: https://manufacturingchemist.com/cellular-origins-why-cell-gene-therapy-manufacturers-should-automate-the-production-process#:~:text=Optimising%2C space time and labour usage *,of every step of the production journey (Accessed 22 January 2026).
5. Hopewell, E, Pike, N, Lembong, J, Hewitt, M, Fekete, N, Filling the gap: the workforce of tomorrow for CGT manufacturing as the sector advances (2024), Cytotherapy 6, pp. 540-45. doi: 10.1016/j.jcyt.2024.03.007.
6. How automation and digital technologies will unlock the full potential of advanced therapies. (2024). Stephen Ward, European Pharmaceutical Review. Available: https://www.europeanpharmaceuticalreview.com/article/240796/how-automation-and-digital-technologies-will-unlock-the-full-potential-of-advanced-therapies/ (Accessed 15 August 2025).
7. Simplifying CGT: A Necessary Precursor to Integrating AI and Automation. (2023). Josh Ludwig, Jai McIntosh, European Pharmaceutical Manufacturer. Available: https://pharmaceuticalmanufacturer.media/pharmaceutical-industry-insights/latest-pharmaceutical-manufacturing-industry-insights/simplifying-cgt-a-necessary-precursor-to-integrating-ai-and-/ (Accessed 22 January 2026).
8. Artificial Intelligence in Pharmaceutical and Biotechnology: Current Trends and Innovations. (2025). Coherent Solution, Inc. Available: https://www.coherentsolutions.com/insights/artificial-intelligence-in-pharmaceuticals-and-biotechnology-current-trends-and-innovations (Accessed 23 January 2026).
9. Melocchi, A, Schmittlein, B, Sadhu, S, Nayak, S, Lares, A, Uboldi, M, Zema, L, Robilant, BN, Feldman, SA, Esensten, JH, Automated manufacturing of cell therapies (2025), Journal of Controlled Release 381, pp. 1-20. doi: 10.1016/j.jconrel.2025.02.057.
10. Value Drivers and Benefits of Closed Processing. (2025). Merck KGaA. Available: https://www.sigmaaldrich.com/ES/es/technical-documents/technical-article/pharmaceutical-and-biopharmaceutical-manufacturing/monoclonal-antibody-manufacturing/value-drivers-benefits-closed-processing?srsltid=AfmBOop5zjNRZW0Tormvg5–K6xEgDJC0JDE_6xoScG-sBoVt4pyza_m (Accessed 16 January 2026).
11. Beyond Urban Centers: Expanding CAR-T Therapy with Decentralized Manufacturing. (2025). Erika Francoeur, Domhnall McGowan, Boston Labs. Available: https://www.bostonlabs.com/beyond-urban-centers-expanding-car-t-therapy-with-decentralized-manufacturing#:~:text=By reducing the need for,& Domhnall McGowan M.Sc (Accessed 22 January 2026).
12. Cutting-edge personalised treatments, made while you wait, will deliver specialised care to patients more quickly. (2025). GOV.UK. Available: https://www.gov.uk/government/news/cutting-edge-personalised-treatments-made-while-you-wait-will-deliver-specialised-care-to-patients-more-quickly (Accessed 15 December 2025).