Innovative logistics solutions are reshaping the way time-and temperature-sensitive biopharmaceutical products are transported globally. By addressing challenges like multiple hand-offs, tarmac delays, and customs inefficiencies, cutting-edge strategies ensure product integrity and reduce losses. These advancements safeguard the stability of life-saving drugs, delivering them securely and efficiently to patients in need.
Rising to the Challenge of Biopharma Logistics
Maintaining the stability and safety of temperature-sensitive products in the biopharmaceutical supply chain is undeniably crucial. Yet, achieving this goal has become increasingly complex due to the surge in temperature-critical drugs, the unrelenting demands of global clinical trials, and the proliferation of low-volume, high-value products. These challenges underscore the importance of robust logistics strategies.
In response to cost pressures and sustainability goals, the use of ocean freight for pharmaceutical shipments has risen significantly in recent years. Ocean carriers provide cost-effective and environmentally friendly solutions, with innovations in temperature-controlled reefer containers and advanced monitoring systems enabling the safe transport of even highly temperature-sensitive biologics over extended durations.
However, when urgency is paramount — such as for clinical trials, novel blockbuster commercial drugs, or biologics with short shelf lives — air transport remains the preferred option. Its unmatched speed justifies its costs and environmental footprint, with over one trillion dollars’ worth of pharmaceutical products shipped by air annually.
Despite its advantages, air transport introduces considerable risks for temperature-sensitive products, accounting for a staggering 80% of reported temperature excursions, compared to just 1% for ocean freight. These vulnerabilities highlight the urgent need to address tarmac exposure — the primary cause of temperature deviations in air freight—to safeguard product integrity and reduce losses across the pharmaceutical supply chain.
Challenges of the Traditional Biopharmaceutical Air Freight Model
Every year, an estimated $48 billion worth of drug substances and finished products are lost due to temperature excursions and other supply chain-related challenges. With air freight responsible for 80% of these temperature deviations, a closer examination of the current pharmaceutical air shipment model is critical.
Biopharmaceutical logistics often rely on a fragmented system involving freight forwarders, commercial airlines, and first- and last-mile drivers tasked with delivering or retrieving cargo from airport warehouses. Although many airports have invested in upgraded temperature-controlled facilities, the existing model still faces significant vulnerabilities. Airlines operate within fixed timeframes for cargo drop-off and aircraft loading, but various disruptions frequently derail these processes, such as:
Aircraft delays: Late arrivals, airport congestion, mechanical issues, and other operational problems
Customs clearance issues: Mismanagement of shipping documents or lengthier-than-expected customs inspections
Miscommunication: Inefficient coordination between logistics providers, airlines, and ground handlers.
Severe weather conditions: Storms, heavy rain, or snow can prevent timely loading or unloading operations.
Shortage of equipment or staff: Frequently leads to ground handling delays
Regulatory and security delays: Security and regulatory checks can take longer than expected, and incorrect or incomplete paperwork further delays the process.
The Ramifications of Prolonged Tarmac Exposure
Biopharmaceuticals and medical supplies demand precise handling, where even minor temperature deviations can render entire shipments unusable. These incidents not only result in costly write-offs but also risk creating critical drug shortages. Since all temperature-controlled packaging has finite time limits, timely delivery is paramount.
Among the various handoff points in a temperature-controlled supply chain, prolonged exposure on the tarmac presents the highest level of risk. The potential consequences include:
Temperature deviations: Prolonged exposure to ambient conditions outside the packaging's design thresholds can lead to product damage. Additionally, solar radiation on the tarmac can further exacerbate temperature increases, jeopardizing the shipment.
Compromised product and packaging integrity: Temperature deviations can lead to the degradation of active pharmaceutical ingredients (APIs), excipients, and other substances, resulting in drug products that may not provide the intended therapeutic effect, or product degradation may result in harmful side effects. Additionally, tarmac exposure can compromise packaging integrity, leading to further supply chain risks.
Microbial growth: Elevated temperatures can accelerate microbial activity, leading to contamination that undermines product safety and efficacy.
Regulatory non-compliance: Breaches in temperature control protocols disrupt Good Distribution Practices (GDP), prompting investigations to assess whether the shipment's critical quality attributes (CQAs) have been preserved. Often, this leads to product disposal.
Patient safety and financial loss: The financial impact of lost shipments is severe, but the consequences for patient health and treatment availability are even more critical. Delays or shortages can hinder access to life-saving medications.
The risks associated with prolonged tarmac exposure emphasize the urgent need for innovative solutions to protect product stability and ensure patient access to essential therapies.
Cutting Tarmac Time with Innovative Distribution Solutions
Leveraging deep expertise in life sciences manufacturing and logistics, Frontier Scientific Solutions has pioneered a transformative model. Instead of adopting a generalized third-party storage and distribution approach, the company has developed targeted solutions to drastically reduce tarmac exposure. Their strategy addresses critical pain points, including excessive hand-offs in conventional supply chains, inflexible commercial air carrier systems, inadequate expertise in airport temperature-controlled facilities, and regulatory, security, and customs delays.
Direct gateways to strategic global markets: Sharply reducing hand-off points, each substantially contributing to the risk of tarmac exposure and other opportunities for temperature deviations, Frontier Scientific Solutions is establishing direct gateways to strategic global markets. Beginning with the gateway to North America in Wilmington, NC, and the gateway to Europe in Shannon, Ireland, Frontier Scientific Solutions flies direct routes between these critical geographies.
On-airport temperature-controlled distribution facilities: Operated by life sciences storage and distribution experts, Frontier Scientific Solutions cGMP facilities have direct tarmac access to ensure rapid loading and unloading of temperature-sensitive products. This proximity is central to minimizing time on the tarmac and preserving the temperature integrity.
Dedicated flights: Today, most life sciences air freight is shipped in the cargo holds of commercial planes. While commercial planes were not designed for life sciences product transport, arguably even more challenging is that the transport of life sciences products on commercial aircraft is subjected to the same delays that are all too familiar to any air traveler. Initially connecting Wilmington, NC, and Shannon Airport (SNN) in Ireland, Frontier Scientific Solutions will offer direct flights exclusively dedicated to life sciences products.
Foreign Trade Zone (FTZ) and Transportation Security Administration (TSA) Indirect Air Carrier Facility designations: Both Wilmington, NC and Shannon, Ireland facilities operate within FTZs (known as free-trade zones outside of the United States). Within FTZs, both foreign and domestic merchandise are treated as international commerce outside the jurisdiction of customs, allowing for increased freedom of movement for goods, minimizing the risk of customs clearance delays, and increasing the speed of delivery. As an Indirect Air Carrier Facility, products are not subject to security delays. This designation ensures that Frontier Scientific Solutions facilities operate in secure, compliant manners, adhering to stringent federal security standards for handling and transporting air cargo.
Eliminating Excessive Tarmac Exposure in Biopharma Supply Chains
Frontier Scientific Solutions has addressed the root causes of excessive tarmac exposure by leveraging its specialized expertise in life sciences storage and distribution. Through a combination of strategic facility placement, direct market gateways, on-runway temperature-controlled storage, dedicated life sciences flights, and streamlined customs and security processes, the company has established a groundbreaking model.
This innovative approach has redefined industry standards, reducing tarmac exposure times from hours—or in extreme cases, days—to mere minutes. By safeguarding temperature integrity at every stage, Frontier Scientific Solutions ensures the secure, efficient, and timely delivery of life-saving, temperature-sensitive biopharmaceutical products to patients worldwide.
References
Mwanalushi, Keith. "Air Cargo: Transporting Temperature Sensitive Pharmaceuticals." Aviation Business News. 5 Dec. 2019.
Shanley, Agnes. "Poseidon Takes on the Pharma Supply Chain.” BioPharm International. 1 Mar. 2018.