In drug development, timelines are unforgiving, and data is everything. Yet, the integrity of the samples underpinning that data is often taken for granted until something goes wrong. A freezer failure at 2 a.m., a power interruption, or a door left ajar: events that seem benign in other industries can derail clinical programs, invalidate stability studies, and wipe out years of effort.

It is tempting to think of disasters in dramatic terms, such as fire, flood, or hurricane. In reality, the pharmaceutical sector is far more often challenged by quieter crises, such as equipment faults, human error, or localized energy or utility outages. These events rarely make headlines, but for companies depending on carefully stored samples, they can be catastrophic.

Disaster recovery as a compliance and continuity issue

The regulatory framework recognizes this risk. ICH Q1A(R2)¹ sets out stability testing requirements. Good Manufacturing Practice (GMP) expectations extend beyond quality of manufacture to include how materials are handled, stored, and documented. Meanwhile, FDA 21 CFR Part 11² and EU Annex 11³ impose strict requirements on electronic records and data integrity.

The message is clear: protecting samples and data is not optional. Disaster recovery must sit alongside stability study design, clinical trial planning, and supply chain management as a core element of pharmaceutical development.

What resilience looks like in practice

A strong disaster recovery framework is not a single piece of equipment, but a layered approach⁴:

• Qualified infrastructure: chambers, cabinets, and freezers that are serviced, validated and regularly re-qualified.
• Data compliance and protections: regulatory-compliant data protection and back-up storage.
• Storage monitoring and escalation: continuous oversight with immediate alerts and response protocols.
• Power continuity: backup supplies and generator capacity to maintain conditions.
• People and process: staff trained in relocation, relabeling, and maintaining chain-of-custody at scale.
• Rehearsed recovery plans: documented and tested, ready for regulatory inspection.
• Validated relocation: pathways and dedicated contingency capacity ensuring uninterrupted temperature control

Not every organization can sustain this level of resilience internally, particularly as operations grow and sample inventories diversify. This is driving many companies to build disaster recovery into their outsourcing strategies, with organizations, such as Astoriom, that offer mirrored storage, rapid-response transfer, and full audit traceability to maintain compliance, especially in emergency conditions

Lessons from the field

One global CRO identified gaps in its ability to protect clinical trial samples if internal storage systems fail. By developing a structured disaster recovery plan with an external partner, including dedicated contingency space, they were able to respond quickly when temperature excursion occurred within a controlled chamber. Tens of thousands of samples were relocated within hours, documented in line with regulatory requirements, and trial timelines continued uninterrupted.

For another global cGMP vaccine biomanufacturer, a severe snowstorm disrupted the transfer of vaccine stability samples shipped in dry ice. Contingency procedures had been rehearsed in advance, allowing staff to clear access, secure the shipment, and place the samples into ultra-low storage before quality was compromised. What could have been a major product loss became a routine recovery exercise. The process was fully aligned with quality protocols, avoiding any sample loss or compliance breach. 

These examples illustrate a broader point: resilience depends on foresight and planning. When recovery is built into strategy and tested in advance, crises can be managed without jeopardizing trial integrity or compliance.

Planning for the full lifecycle

Disaster recovery is not just about “what if” analysis. It is also about planned scalability. As companies progress from discovery to late-phase trials and post-approval stability programs, sample storage demands multiply across different temperature bands (ambient, refrigerated, frozen, cryogenic), expanding inventories, and increasingly complex regulatory oversight across regions.

Hybrid models, where in-house storage is supplemented by outsourced capacity, are emerging as pragmatic best practices. They allow companies to manage day-to-day operations internally and outsource sample storage as needed, while having validated, regulatory-compliant contingency capacity available if the unexpected disaster occurs. Crucially, these flexible models can grow with a program and ensure continuity throughout the development lifecycle.

Resilience as strategy, not insurance

Too often, disaster recovery is viewed as an insurance policy, an added cost to be justified only if disaster strikes. In reality, it is a strategic enabler. It protects irreplaceable sample assets which ensures trial timelines, upholds regulatory commitments, and ensures investments in R&D translate into future therapies.

Industry is increasingly recognizing that resilience cannot be improvised when systems fail. It must be designed, documented, and tested. Whether through internal investment, external partnerships, or hybrid models, organizations that integrate disaster recovery into their storage strategies are better positioned to safeguard samples, data and research innovation.

Resilience is not about reacting to disaster; it is about ensuring that the science continues, no matter what challenges arise.

References

1. https://database.ich.org/sites/default/files/Q1A%28R2%29%20Guideline.pdf
2. https://www.fda.gov/media/75414/download
3. https://health.ec.europa.eu/system/files/2016-11/annex11_01-2011_en_0.pdf
4. https://www.astoriom.com/insight/practical-strategies-for-sample-storage-and-stability/

Philip Bradley is the General Manager at Astoriom, bringing nearly a decade of experience within the life sciences industry. Specializing in stability storage services, Philip oversees operations across Astoriom’s multiple locations, ensuring the delivery of high-quality, temperature-controlled solutions that meet stringent compliance standards.