Abstract
Contract Research Organisations (CROs) are increasingly adopting organoid models for drug discovery, toxicology, and preclinical testing. These three-dimensional cellular systems provide superior physiological relevance compared to traditional two-dimensional cultures. However, their implementation within CRO pipelines is constrained by practical challenges: reproducibility, scalability, and especially preservation and logistics. Recent evidence from Atelerix’s Liver Organoids Preservation White Paper demonstrates how ambient temperature preservation using WellReady™ can help CROs overcome these barriers, ensuring consistent delivery and maintaining functionality of organoid models during transport [10].
Why CROs Are Turning to Organoid Models for Drug Discovery
Pharmaceutical and biotech clients are increasingly demanding physiologically relevant models to reduce attrition in drug pipelines. CROs that offer organoid-based services can differentiate themselves by providing data that better predicts human outcomes compared to 2D cell lines or animal models [1,2].
Patient-derived tumour organoids, for example, have already been shown to capture clinical responses in gastrointestinal cancers [3]. Similarly, airway organoids can be expanded long-term and applied in disease modelling [4]. Even cystic fibrosis intestinal organoids are now being used for patient-specific drug response testing, demonstrating the translational relevance CRO clients are demanding [5].
Yet organoids also introduce new operational challenges. Unlike traditional immortalised lines, they are more fragile and less suited to standard cryopreservation workflows. For CROs that depend on reproducibility and speed of delivery, this fragility can limit the scalability of organoid-based services.
Key Organoid Preservation Challenges CROs Face in Multi-Site Studies
- Ensuring Reproducibility of Organoid Assays Across CRO Sites
Clients expect reproducible results across sites and studies. Variability introduced by freeze–thaw cycles can compromise viability and morphology, reducing confidence in results [7].
- Shipping Organoids Without Cryopreservation for Faster Turnaround
Cold-chain transport using liquid nitrogen or dry ice is costly, logistically complex, and vulnerable to delays at customs or in transit [8]. For CROs operating global services, these risks translate directly into lost time and revenue.
- Scaling CRO Organoid Services Globally Without Cold-Chain Barriers
As demand for organoid-based assays grows, CROs need logistics solutions that scale globally. Cryogenic shipping infrastructure is expensive to maintain and limits the ability to expand services to new regions.
Evidence That CROs Can Use Ambient Organoid Preservation With WellReady™
The Atelerix Liver Organoids Preservation White Paper provides compelling evidence that organoids can be preserved at ambient temperature for up to five days using WellReady™. In this study, iPSC-derived murine liver organoids were cultured in Matrigel, then stored at 20°C in ready-to-ship plates [10]. Upon release, organoids demonstrated:
- High viability and continued growth, confirmed through calcein-AM live cell staining (Figure 1).
- Retention of structural integrity, with consistent hepatic marker expression (Figure 2).
- Maintenance of metabolic activity, shown by ATP levels measured via CellTiter-Glo® (Figure 3).
- Preserved drug-metabolising enzyme activity, demonstrated by CYP1A2 function (Figure 4).
These findings confirm that liver organoids preserved in WellReady™ retain both morphology and function post-shipment, removing the freeze–thaw bottleneck [10].
Figure 1. Live (green) and dead (red) staining of liver organoids after 5 days at 20°C using WellReady™, followed by recovery in culture. Organoids maintained high viability [10].
Figure 2. Immunofluorescent staining of CK19 (green) and Hoechst nuclear stain (blue) shows preserved structural integrity of liver organoids following 5-day ambient storage [10].
Figure 3. ATP levels of liver organoids preserved in WellReady™ at 20°C for 5 days, assessed after 72-hour recovery. Values indicate maintained viability [10].
Figure 4. CYP1A2 activity measured in liver organoids after 5 days of ambient preservation in WellReady™, followed by 72-hour recovery. Enzyme function was retained [10].
Benefits of Ambient Organoid Preservation for CRO Drug Discovery Workflows
For CROs, the implications are significant:
- Operational efficiency: Eliminate time lost to freeze–thaw recovery.
- Client confidence: Deliver consistent, reproducible samples that maintain viability and drug-metabolising functionality.
- Cost reduction: Avoid expensive cryogenic shipping infrastructure and reduce logistical complexity.
- Scalability: Enable global shipment of organoid assays, supporting multi-site studies and cross-border projects.
- Regulatory alignment: Ensure chain-of-custody integrity and audit readiness with simplified workflows.
By embedding organoids in WellReady™, CROs can strengthen their service reliability, improve turnaround times, and expand offerings without the constraints of cold-chain logistics.
| Cryopreservation (Current Standard) | WellReady™ Ambient Preservation (Next Generation) |
| Freeze–thaw cycles: Risk of cell damage, reduced viability | Ambient stability: No freeze–thaw damage |
| Complex logistics: Requires dry ice or LN₂ supply chain | Simple logistics: Shipped at room temperature |
| Delays: Customs risks and recovery time after thawing | Faster turnaround: No recovery time, ready-to-use |
| High costs: Expensive infrastructure, hard to scale | Lower cost: No LN₂ or dry ice needed |
| Variability: Inconsistent results, reduced reproducibility | Consistency: Reliable reproducibility across sites |
| Limited global reach: Requires specialised infrastructure | Scalable: Easy cross-border shipping, supports global CRO services |
Future of CRO Organoid Services: From Preservation Challenges to Scalable Solutions
The adoption of organoids by CROs is set to increase as pharma and biotech clients push for more human-relevant data in drug discovery and toxicology testing. To scale effectively, CROs will need solutions that simplify organoid logistics and ensure reproducibility across projects.
Atelerix’s WellReady™ technology directly addresses these pain points. By enabling room temperature shipment of ready-to-use organoids, CROs can focus on delivering high-value services without being constrained by cold-chain risks.
Conclusion
For CROs, organoid-based services are both an opportunity and a challenge. The opportunity lies in offering predictive, human-relevant models that align with client and regulatory expectations. The challenge lies in overcoming the preservation and logistics bottleneck.
WellReady™ offers a proven solution. By maintaining organoid viability, structure, and drug-metabolising function at ambient temperature, it provides CROs with a competitive edge in reproducibility, efficiency, and scalability [10].
To explore the full data and methodology behind these findings, download the complete Atelerix White Paper on Liver Organoid Preservation and see how your CRO can benefit from a more reliable and cost-effective approach to organoid logistics.
References
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- Atelerix Ltd. Storage of Liver Organoids at Room Temperature Using WellReady™. White Paper v2.1. 2023
