Philip Bradley, general manager at Astoriom shares why robust temperature control is essential to protect product integrity, compliance, and patient safety.
Astoriom
Pharmaceutical manufacturing demands precision at every step. Cold chain failures are a leading, yet preventable, cause of product loss. Active pharmaceutical ingredients (APIs), intermediates and finished medicines are made in line with Good Manufacturing Practice (GMP) guidelines to ensure safety and consistency. But quality is not determined by manufacturing alone. The way products are stored, both during production and after release, is equally critical. For Europe’s expanding portfolio of temperature-sensitive biologics, vaccines, and advanced therapies, robust cold chain control is now a regulatory and operational imperative, as cold chain failures can undo months of controlled production in a matter of hours.
Cold chain failures
Regulators including the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) frequently cite storage lapses in recall notices. These failures often occur after production, when stability chambers, fridges or freezers malfunction, or records are incomplete.
A lost batch may represent millions in wasted investment. Supply chains can stall, leaving patients without treatment, and reputations built over decades may be damaged by a single incident. Because stability data must remain intact throughout the product’s lifecycle, any uncertainty about temperature history can force entire batches to be discarded.
Recent cases underline the seriousness of storage lapses. In Ireland, the Health Service Executive (HSE) discarded 22 vials — equivalent to around 130 doses — of the Pfizer/BioNTech COVID-19 vaccine as a precautionary measure after these were stored outside the required cold chain conditions. This illustrates how even a single lapse in temperature control can render critical medicines unusable.
Pharmaceutical stability and temperature control requirements
Storage temperature requirements vary not only between products but also between development stages:
Each range slows degradation in its own way. However, it is temperature consistency, not merely range, that determines product viability: even brief deviations can reduce potency. A vial may look unchanged after a temperature excursion, yet its therapeutic effect could already be compromised.
Pharmaceutical cold chain regulations
These technical requirements are reinforced by a tightening regulatory environment. At EU level, the European Commission’s Good Distribution Practice (GDP) guidelines govern storage and transport across Member States. In the UK, the MHRA enforces GDP through its Rules and Guidance for Pharmaceutical Distributors (Green Guide), inspecting how records are kept and how deviations are managed. For controlled substances, additional licensing applies separately in the UK under the Misuse of Drugs Regulations 2001 and in Ireland under the Misuse of Drugs Acts 1977–2016. Many Irish and continental European facilities are also subject to Health Products Regulatory Authority and local competent authority audits, requiring full traceability and validated monitoring. The regulatory message is consistent: medicines must remain within validated conditions from production to patient.
Best practice in cold storage and GDP compliance
Cold storage must not be a logistical afterthought. It is part of the quality system and subject to regulatory scrutiny. Manufacturers are expected to demonstrate that their storage environments are validated, monitored and properly maintained. Validation is carried out through installation, operational and performance qualification (IQ, OQ, PQ). Chambers and freezers should be mapped to confirm temperature uniformity. Continuous monitoring must be in place, with alarms and escalation procedures for deviations. Redundancy, whether through backup power supplies, spare capacity or dual liquid nitrogen feeds, reduces risk. Full traceability, supported by barcoding, audit trails and electronic records, provides the assurance regulators demand.
Common cold storage failures
Yet even robust systems can fail. Capacity constraints and ageing infrastructure remain recurring pain points across manufacturing sites. Space is a recurring challenge: stability chambers are large, often running at full capacity, leaving little margin when something goes wrong. In some organisations, scientists are asked to manage storage alongside their research duties, while others split responsibility across multiple vendors, complicating accountability and audits.
Advanced therapies can hinge entirely on storage infrastructure. At one European research facility, a liquid nitrogen tank failure led to the loss of irreplaceable cell therapy material, halting clinical progress.
Challenges in oncology and advanced therapies
Oncology and advanced therapies naturally bring higher stakes. Clinical oncology studies may involve hundreds of paraffin-embedded slides stored at ambient temperature, alongside molecular extracts that must remain frozen at –80 °C. Blood samples processed into peripheral blood mononuclear cells require cryogenic storage.
For advanced therapies, the risks are even sharper. Viral vectors and engineered cells are fragile, often patient-specific and impossible to replace. A missed liquid nitrogen refill or ultra-low freezer failure can halt a trial, delay treatment and leave patients without options. For European Advanced Therapy Medicinal Product developers, such failures can also lead to delayed qualified person release and additional regulatory submissions, compounding the cost of downtime.
Building resilience
With scrutiny increasing, manufacturers must plan not only for routine operations but also for unexpected disruption. Resilience means more than installing alarms. It requires layered safeguards: redundant power and cooling systems, automated liquid nitrogen monitoring, disaster recovery contracts, and staff trained to respond to failures. Some organisations reduce risk further by distributing storage across multiple locations, safeguarding samples against regional hazards, such as floods or wildfires. In Europe, this multi-site resilience is increasingly integrated into Business Continuity Plans to align with ISO 22301 and MHRA expectations. These measures can be resource-intensive, which is why many turn to specialist partners, such as Astoriom, for support.
Ensuring continuity from production to patient
When failures do occur, the ability to respond swiftly can determine whether samples — and entire trials — are saved or lost. One CRO took out a disaster recovery contract as a precaution to cover the risk of cold storage failure. When its 5°C walk-in chamber failed, leaving thousands of client samples at risk, Astoriom organised immediate collection, transported the samples under controlled conditions, and placed them into validated storage in line with GMP and GDP expectations. Because repairs were delayed, the samples were transitioned into long-term managed facilities, with trial protocols updated to reflect the change. The intervention not only averted a major loss but also allowed the CRO to maintain its testing schedules without disruption.
Tailored GMP- and GDP-compliant storage solutions
Similar challenges arise across the sector but they can be mitigated through specialist support. A large pharmaceutical manufacturer avoided disruption by embedding year-round validation and maintenance support from Astoriom for dozens of stability chambers, ensuring equipment stayed in specification. And a biopharmaceutical company working with advanced therapies overcame capacity limits by adopting a split-site cryogenic storage model, distributing sensitive cell lines across two locations to safeguard them against localised failures. Infrastructure, regulatory expertise and rapid response can safeguard not just samples but entire development pipelines. Ultimately, this is about more than preserving data or protecting assets — it is about ensuring that promising therapies continue their journey from the laboratory to the patient without interruption. By working with specialist partners, companies can strengthen their cold storage strategies, avoid costly setbacks and, most importantly, advance vital, life-changing treatments to the people who need them most.