The emergence of novel and highly efficacious Cell and Gene Therapies (CGTs) in life sciences presents numerous logistical and transportation challenges for the pharmaceutical industry. To address these challenges, pharmaceutical companies are implementing innovative approaches to their logistics operations.
A brief introduction to CGTs can be simplified as therapies that offer personalized and targeted treatments for a number of rare and chronic diseases. These therapies are classified into two main types: autologous and allogenic.
Handling these therapies is complex at every step, including the transportation of autologous therapies. Such autologous therapies are based on a closed-loop supply chain where the journey starts and ends with the patient. The complexity of such a supply chain arises in multiple areas, especially related to logistics. The logistical process for autologous therapies is as follows: Apheresis samples are transported from the clinic to the manufacturing site and then back, sometimes requiring multiple shipments. Given the zero-error tolerance and the need to meet regulatory requirements, the entire process is time-sensitive and demands unique handling and packaging procedures at all stages, from apheresis to the final drug product. The complexity increases when the product needs to be transported across regions with limited connectivity.
This introduces new parameters for pharma logistics that differ significantly from those required for traditional pharmaceutical products.
Transporting a CGT product must be completed within a limited timeframe, as delays due to inspections or regulatory non-compliance can significantly impact product quality. Invasive interventions like X-ray scans can also be detrimental. Therefore, securing exemptions for X-ray inspections is crucial for ensuring smooth logistics and supply chain continuity. To achieve this, efficient processes need to be established while considering regulatory requirements throughout the entire operation.
To meet the supply chain requirements for CGTs, especially in new markets with limited local presence, the role of pharmaceutical companies’ partners is essential to execute the transportation of such therapies, especially across borders. From experience witnessed over time, only a limited number of companies (logistics service providers, distributors, etc.) have the expertise and capabilities to handle complexities related to cold chain management, real-time tracking, and specialized packaging.
Real-time monitoring (Track and Trace) is not yet a reality for most players in pharma logistics, often resulting in delays in promptly addressing issues. Implementing standardized processes, integrating innovative technologies, and enhancing communication can help standardize operations and mitigate differences in reporting, language barriers, and regulatory variations.
The widespread use of on-board couriers for apheresis sample transport is currently the safest option in terms of visibility. However, this solution presents a scalability challenge. To efficiently scale CGT production, pharmaceutical companies need to explore alternative transportation methods.
Relying on a single shipping route for CGT components makes the supply chain susceptible to unforeseen disruptions. Given the limited transportation timeframes for CGT products, flexibility and adaptability are crucial. Implementing contingency plans and diversifying transportation methods can enhance resilience in logistical operations.
Strategic adjustments in pharma logistics operations must address regulatory compliance, technological integration, partnerships with logistics providers, and the exploration of diverse transportation methods. All stakeholders across the value chain need to be well-informed about processes, documentation, and logistics requirements to ensure the successful delivery of the final drug product to the patient.
Regulatory standards tend to differ across regions and countries, especially in relation to importing and exporting CGTs which create a complex environment for transportation and pharma logistics. Prior to the commercialization and launch of therapies, it is essential to engage with stakeholders early, plan and execute mock shipments, map and validate processes, and define roles and responsibilities to manage this complexity effectively. For instance, securing approvals for X-ray exemptions in advance for radiation-sensitive goods can be beneficial. Proactive interactions help prevent delays and improve stakeholders’ understanding of their roles.
Pharmaceutical companies need to engage multiple logistics service providers (LSPs) to create a robust transportation setup, particularly when targeting specific countries. While global LSPs often form local partnerships to serve pharma clients, these local partners may sometimes lack the necessary expertise or capabilities.
To mitigate the risk of courier underperformance or failure to meet requirements, engaging multiple partners can be advantageous. Enhancing the likelihood of success involves streamlining the logistics process for CGTs through cross-functional collaboration, involving all key stakeholders, and assessing their operational capabilities in relation to specific requirements.
Visibility in pharma logistics is achieved through the implementation of standardized processes and the use of technology for data integration. The aim is to align reporting systems and ensure compliance with quality standards for all stakeholders. Clear communication channels are essential but investing in real-time tracking & tracing and data analytics is equally important for enabling proactive decision-making and minimizing the impact of operational disruptions.
However, integrating technology can initially introduce complexity. This can be mitigated by establishing clear roles and responsibilities among all stakeholders – especially when collaborating with local players – and by implementing effective communication channels, processes, and procedures.
Currently, pharmaceutical companies rely on on-board couriers and air cargo as transportation options. The preference for the transportation option varies depending on the desired level of visibility and control, country restrictions (such as the complexities associated with X-Ray exemptions via on-board courier), and scalability limitations (such as the limited number of shipments that can be managed via on-board courier). Choosing the appropriate transportation options and logistic partners requires an exhaustive evaluation process that weighs the pros and cons across multiple criteria.
Both transportation options should be activated by pharmaceutical companies to ensure flexibility and adaptability. Prior to utilizing any of the options, the shipment flow and process need to be thoroughly mapped with the relevant stakeholders (internal and external) and validated through mock shipments. Typically, pharmaceutical companies may start with on-board couriers and transition to air cargo as they gather the necessary knowledge of the country’s regulatory framework.
Additionally, establishing and validating multiple routes (at least three where possible) is crucial for developing backup plans to address potential shipping disruptions. This strategy allows for quick adjustments to unforeseen challenges, ensuring the consistent and timely delivery of CGTs to patients.
Transporting autologous therapies requires meticulous handling procedures, which introduce multiple challenges. To achieve successful shipments and scalability, it is crucial to emphasize proactive measures. Such measures include cross-functional collaboration, ensuring regulatory understanding and compliance across markets, partnering with life science and pharma logistics experts (CGT-centric), integrating advanced technology (Orchestration platforms that enable tack and trace mechanisms),
By implementing such measures, pharmaceutical companies can better navigate the complexities associated with autologous therapies and support commercialization efforts.
This article was also published on the website of Hypertrust, a spin-off of Camelot Group specialized in making advanced therapy medicinal products safer and better.
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