Sustaining the Future of Life Science Product Research

By: Lori A. Ball, Chief Executive Officer, Astoriom; Philip Bradley, General Manager, Astoriom

Few people say it outright, but the integrity of stored research and clinical samples underpins all scientific and medical progress. Every breakthrough drug, advanced therapy, or medical device depends on millions of biological, chemical, and physical samples that must be preserved intact across the entire product lifecycle. These are fundamental for regulatory submissions (FDA, HTA, CAP, ICH), validate safety and efficacy, and ultimately, determine whether promising therapies reach patients.

Experience shows, however, that safeguarding sample stability and biorepository storage in life sciences is one of the most underestimated challenges. Cell and gene therapies (CGTs), oncology research, and precision medicine demand extreme conditions. Decentralized trial models introduce unpredictable logistics. Regulators are raising expectations, and deviations are common inspection findings. In this environment, relying on fragmented storage, outdated monitoring, or untested recovery plans is no longer viable. The financial, regulatory, and reputational consequences of failure are simply too high.

When Storage Fails, Science Falters

Sample storage failures are not rare anomalies. They are recurring events that have halted trials, triggered recalls, and destroyed years of work. The financial cost can reach millions per day in delayed revenue for high-value therapies, but the deeper consequences are reputational and regulatory.

The life sciences industry has seen multiple high-profile recalls due to temperature excursions. Vaccines typically require strict storage between 2–8°C, with excursions outside this range rapidly compromising efficacy. Ultra-cold chain products, such as mRNA-based vaccines, must be stored at –60°C to –80°C, while certain CGT materials require cryopreservation below –150°C in liquid nitrogen vapor phase.

Even short deviations from required temperatures, can irreversibly damage potency use of samples. Real world recalls illustrate the risks: In 2021, a top generic pharmaceutical developer issued a nationwide recall of a lot of enoxaparin sodium injection after a temperature excursion during shipping raised concerns that its effectiveness as an anticoagulant may have been compromised.¹ In the same year, a generic drug manufacturer voluntarily recalled approximately 1,468 insulin product samples after these had been stored below 0°C, with the company warning this could reduce efficacy and damage cartridges and pen injectors.²

Beyond high-profile recalls, day-to-day operational failures can be just as damaging. For example, pharmaceutical and biotech organizations where a 5°C walk-in stability room failed without warning, placing months of study material at risk. Only rapid transfer into validated storage chambers prevented a total loss of stability. In other cases, facilities that relied on single-point chambers with no backup capacity have required support to ensure a single failure didn’t compromise entire studies. These are not isolated accidents but examples of systemic vulnerabilities that continue to undermine confidence in sample stewardship across the industry.

How Complexity Increases from Lab to Market

Safeguarding stability is not a single challenge but should occur across the research to therapy development lifecycle. Each stage of the product lifecycle brings new risks:

For example:

• Early research: Small volumes stored in laboratory freezers often compromised by inadequate calibration or monitoring. Even at this stage, best practice is to avoid storing whole blood or plasma at room temperature for more than 2–4 hours before processing; beyond that, samples should be refrigerated at 2–8°C or frozen at –20°C to –80°C depending on analyte stability.
• Clinical trials: Thousands of samples moving across borders and climates, where maintaining ICH stability conditions and secure chain-of-custody is critical. Plasma, serum, and biomarker samples intended for pharmacokinetic or biomarker analysis are typically aliquoted and stored at –80°C to prevent degradation, with strict limits on freeze–thaw cycles.
• Regulatory submission: Inspection-ready data packages where every deviation must be logged and every chamber validated. Missing records can delay approval by months.
• Commercialization: Retention and pharmacovigilance obligations, where compromised samples can call entire product batches into question.
• Archiving: Storage for 15–30 years, demanding robust systems that combine energy efficiency with disaster recovery. For long-term archiving, liquid nitrogen vapor storage (–150°C to –196°C) is the gold standard for stem cells, cord blood, and certain genetic materials, ensuring decades of viability when supported by validated cryopreservation protocols.

A single new therapy can generate more than a million samples over its lifecycle. Protecting these requires foresight, investment, and discipline. Here, we explore how integrated biorepository and stability storage models can be structured to improve both compliance and sustainability.

Risks of a Fragmented Approach

Many organizations still spread samples across a patchwork of labs, depots and external warehouses. While each site may meet basic standards, the overall system is inconsistent and fragmented.

In practice, this fragmentation leads to duplicated testing, reconciliation delays, and missed deviations. Auditors frequently identify gaps in documentation or inconsistencies across providers. The financial impact is significant; operating costs can rise significantly compared with an integrated model, but the greater risk is reputational, as fragmented systems rarely withstand regulatory scrutiny without findings.

Designing Resilience, Not Just Responding

Best-in-class organizations build resilience into their systems. This is not about contingency plans filed away for emergencies; it is about embedding lifecycle planning, continuous monitoring, redundancy and disaster recovery plans into everyday practice.

Examples speak for themselves. During a severe snowstorm, a shipment of vaccine stability samples, packed in dry ice with a narrow time window for delivery, faced significant disruption on its way to an Astoriom facility. Because contingency procedures had been tested and rehearsed, staff were able to clear access routes, transfer the materials, and secure these in ultra-low storage before stability was compromised. The result was business continuity instead of a costly product loss.

Yet, it is not just extreme weather events that pose a risk. Power outages, equipment malfunctions, supply chain delays, and even cyberattacks on monitoring systems can all compromise sample stability. The real differentiator is whether organizations detect and respond to these threats in time. Those with rehearsed contingency plans and resilient systems maintain continuity, while others only discover failures after the damage is done.

There are many documented cases of organizations, from trial sponsors to contract manufacturers, receiving FDA observations after freezers or chambers deviated outside acceptable ranges but failed to trigger alerts. In one recent FDA Warning Letter to a contract manufacturer,³ inspectors found that stability-chamber temperature and humidity alarms had been disabled or left out of range without timely response or documentation. The facility also lacked sufficient validation of its chambers, demonstrating how lapses in alerting and validation undermine stability controls. In another case involving a drug manufacturer, the FDA identified prolonged failures to maintain required refrigeration temperatures for an active pharmaceutical ingredient, with quality impact.⁴

So, resilience is the difference between disruption and continuity. Organizations that embed it into everyday operations protect their samples, their timelines, budgets, and reputations.

Balancing Compliance with Sustainability

Sample stewardship also carries heavy environmental costs. A single –80°C freezer can consume as much energy annually as an average household,⁵ and cold storage can account for up to 70% of a research facility’s total energy use.⁶ Best practices for sustainable stability storage and biorepository solutions include aliquoting samples before freezing to reduce unnecessary door openings, using temperature-monitored freezers with alarms, and limiting samples to 1–2 freeze–thaw cycles to preserve stability.⁷

With biologics and personalized therapies on the rise, demand is only increasing. Forward-looking organizations tackle sustainability alongside compliance by:

• Matching storage conditions to validated requirements, not defaulting to the coldest option.
• Using energy-efficient infrastructure and predictive monitoring to cut waste and energy use.

Centralized stability chambers and global biorepository solutions optimize freezer loads and consolidate monitoring, delivering sustainability at a scale.

The Case for Integrated Partnerships

The future of sample stability and biorepository solutions lies in integrated partnerships that cover the full lifecycle. By consolidating stability studies, storage, monitoring, biorepository and disaster recovery under a single quality system, sponsors reduce duplication, simplify compliance, and allow their own teams to focus on innovation.

In practice, an integrated sample storage and stability outsourcing model delivers faster turnaround times, improved business continuity assurance and the flexibility to scale without heavy capital investment. For sponsors under pressure to accelerate development while reducing costs, this approach offers the ability to re-invest cost-savings and resource utilization into core research competencies. In parallel, we have translated best practices from our experience in managing sample storage to offer a framework that distils international guidance into storage considerations for biologics, advanced therapies, drugs and medical devices.⁸ This supports teams in recognizing the applicable regulations and standards when deciding how to manage research and clinical assets and in developing storage strategies suited to their needs.

Securing the Future of Life Science Research

It’s clear the complexity of life sciences, CGTs, and personalized medicines will only increase, placing greater demands on storage and stability. Organizations that adopt integrated, resilient, and sustainable sample storage strategies, will not only strengthen compliance but also gain a competitive advantage in efficiency and reputation. Best practice guidelines, such as those developed by Astoriom, can provide a high-level framework of critical considerations, distilled from regulatory agencies and best practices organizations, to help implement storage solutions and safeguard sample stability.⁸