Demystifying the Pharmaceutical Logistics Provider: Matching Shipper’s Needs with Transporter’s Capabilities

 Today’s pharmaceutical research environment is fraught with challenge. The scope is global and the stakes are high. Drug discovery, clinical trials, pharmacokinetic/pharmacogenetic analysis, life sciences, and therapeutic applications including cord blood and stem cell treatments all increasingly rely on temperature-controlled transport, storage and distribution to efficiently connect the targeted patient/patient population with the hospital, lab or investigator site. The farther the distance to be travelled, the greater the need for a strong organizational network, knowledge, experience, accuracy, speed and reliability on the part of the logistics provider. 

What should researchers look for when choosing a logistics provider for ultra-sensitive pharmaceutical consignments? Because the needs are diverse and the geography far-reaching, World Courier’s Mattias Mineur suggests to first focus on the fundamentals - GxP compliance, a global reach and proven pharmaceutical transport experience - and then identify specific capabilities that address individual needs.

Why GxP?

In today’s world of global clinical trials, the in-transit temperature control of biopharmaceutical products faces ever-increasing scrutiny from regulators entrusted with ensuring product quality and protecting patient safety. For researchers in the lab, verifiable ‘in spec’ temperatures of biological samples is inextricably linked to the quality of the research findings. For practitioners shipping tissue samples, cord blood or stem cells for therapeutic interventions, maintaining the integrity of these fragile biologicals can be a matter of life and death. In each of these cases, GxP is universally accepted as the worldwide standard of compliance and quality oversight.

“GxP compliance is the cornerstone of responsible biopharmaceutical research, product development and therapeutic patient application,” says Mattias Mineur, World Courier’s Regional Manager Nordic.. According to Mr. Mineur, all international regulatory agencies now call for strict GxP compliance throughout the entire length of the pharmaceutical supply chain - including transport, storage and distribution - during both the development (clinical trial) and commercialisation phases. It is the pharmaceutical company’s responsibility to ensure that all supply chain participants comply with all applicable regulations including temperature and product stability requirements. Penalties for non-compliance are severe and may include regulatory warnings, fines, declined new drug applications, and loss of partnerships and professional reputation. 

“By partnering with a GxP-compliant logistics provider,” says Mr. Mineur, “pharmaceutical professionals are assured of regulatory compliance not only in the labs and hospitals, but at all points in between.” They are also assured that each shipment is consistently handled according to established SOPs and receives the same level of service regardless of where in the world it is destined.

Succeeding in Emerging Markets

A high level of service consistency has never been more important than for shipments destined for emerging markets. In today’s red-hot world of pharmaceutical development, researchers have increasingly turned to these locations to conduct studies, attracted by progressive legislation, a welcoming business environment, low-cost operations, skilled technical personnel and easy access to large pools of treatment-naïve patients. By some estimates, as many as 40% of all clinical trials will be conducted in emerging nations in Asia, Latin America and Africa by the year 2012. 

But assuring compliance through GxP is only the beginning when doing business in these locations. When choosing a logistics provider for these often challenging destinations, it is critical that pharmaceutical shippers understand the local service capabilities of their provider in each individual country or market where shipments will travel. In view of the extreme temperature variations in many of these locations, local expertise in managing temperature-controlled shipments is imperative as is access to qualified thermal packaging solutions and a solid understanding of the local customs and regulatory environment.

“Many logistics providers rely on external sub-contractors to manage local operations in emerging nations under the supervision of a small number of corporate offices,” says Mr. Mineur. He cautions pharmaceutical shippers to know exactly who will be handling their shipments in each location - the provider’s own staff, or a sub-contracted third party - and to find out how SOPs are implemented and quality is assured locally. “It is not enough that a company is GxP-compliant in key locations like London or New York. It must be regulated throughout the provider’s entire network so that customers can be assured of systemic quality and reliability in every contracted location.”

Specialised Focus

Finally, Mr. Mineur suggests, all logistics companies are not created equal. High-volume transport providers typically prevail by using a consolidated, hub-system business model that keeps costs low and individualised staff interventions to a minimum. Other providers have adopted a specialised business model that caters to customers in demanding industries with specific requirements.

Given the intrinsic nature of pharmaceutical shipments - virtually all are highly time- and temperature-sensitive, high value and mission-critical - pharmaceutical shippers should seek out providers with a proven track record in managing these types of shipments. What percentage of the service provider’s business is derived from time- and temperature-sensitive shipments? from pharmaceutical shipments? How many clinical trials have been managed? over what period of time? What are the experiences of other colleagues with this supplier? How is the provider perceived within the industry?

Beyond this, clinical trial customers may also be interested in learning whether the provider offers local temperature-controlled storage facilities and/or validated thermal packaging solutions, what type of inventory management systems may be available, and whether refrigerants can be replenished in-transit.

Shippers transporting stem cells, cord blood, or bone marrow may be more concerned with the service provider’s emergency response capabilities. Can service be expedited 24x7? Does the company offer flexible routing alternatives like dedicated drive-aways and hand-carries? What is the ‘trigger time’ to coordinate an on-board courier? 

Regulatory compliance. Temperature-controlled expertise. Quality management and oversight. Speed and reliability. These are the fundamentals that cannot be compromised. “Beyond this,” says Mr. Mineur, “every shipper has unique needs. We encourage customers to first understand their own requirements and then to challenge their provider’s ability to meet them.”