With growing demand for global, temperature-sensitive healthcare shipments, organizations must develop more robust supply chain solutions.
According to Grand View Research, the global biologics market is expected to reach nearly $400 billion by 2025, a growth rate of almost 4 percent. A steady rise in specialized drugs and sophisticated therapies allowing patients to live longer, healthier lives is driving this change.
Such trends are also raising the stakes in how high-cost, highly-sensitive biopharmaceuticals, biosimilars and specimens are packaged and transported across healthcare supply chains.
Temperature-sensitive packaging is even more vital as drugs, vaccines and samples that have fallen out of optimal temperature range or aren’t packaged properly can become damaged, spoiled or altogether useless.
Biopharma and lab specimens can be some of the most complex to move in the supply chain. Temperature-control packaging and shipping trends will continue to evolve, and pharmaceutical and life science companies must continue to move toward more secure shipping solutions, particularly during last-mile transportation.
“Controlling the temperature of biologics and specimens is a major challenge.”
Fortunately, shippers are taking advantage of more complete protection of payloads end to end, as well as leveraging data from their carriers such as ambient temperature environment and package orientations to develop more effective last-mile solutions. For small packages – but particularly for freight – that means more controlled-room temperature (CRT) solutions requiring enhanced shipping environments.
A key consideration
High-cost, high-value therapies can’t simply be picked up over the counter. They are prescribed and delivered to the patient’s doorstep or the doctor’s office.
Nowadays, a month’s supply of certain medicines can cost tens of thousands of dollars. If these medicines are delayed or lost, and consequently have fallen out of optimal temperature range, the product runs a high risk of becoming ineffective or even harmful to the patient. Persisting complexities include intermodal transportation, which impacts pharmaceutical packaging.
Extended time in transit exposes the packaging to temperature fluctuations, increasing risk. Ocean transportation increases risks through container placement on the vessel, sunlight exposure, container insulation and dwell time on the dock – all introducing additional packaging stresses.
Understanding vaccine complexities
Controlling the temperature of biologics and specimens is a major challenge. The same goes for vaccines, particularly in countries with warm or hot climates – keeping in mind the storage and shipping limitations within developing countries. Immunization now averts an estimated 2 to 3 million deaths every year.
An additional 1.5 million deaths could be avoided, however, if global vaccination coverage improves.
“An additional 1.5 million deaths could be avoided if global vaccination coverage improves.”
Vaccines are biological products and generally need to be shipped and stored to the exact standard set by the manufacturer. Any temperature excursion will impact stability of the product. The key is understanding the complexity and uniqueness of each type of shipment. Some vaccines are sensitive to strong light and to fluorescent lights, for example.
The amount of time that a vaccine can be safely shipped and still retain efficacy can vary according to the vaccine, the packaging and environmental conditions.
Inadequate shipping conditions (including accidental freezing, a threat that could be overlooked during logistics planning) can also increase vaccine waste and increase manufacturing costs associated with producing more lots, as well as increase the time delay until a vaccine can be provided to vulnerable patients.
The supply chain needs to be mapped out in detail during the clinical development stages, and the lanes need to be qualified all the way from the manufacturer to the site where the vaccine will be administered. The supply chain needs to include contingency plans and take into consideration all local and country regulations for each region.
Home care ups the ante
Many studies – particularly in the U.S. and Europe – focusing on chronic disease care are showing a shift toward care outside the hospital setting. Home care frees up hospital capacity, allowing greater focus on specialist surgery, diagnostic, acute and emergency care.
And economics plays a role, too: As medical costs increase, patient-centered care has the potential to significantly reduce expenses both to governments and individuals. To deliver the benefits of patient-centered medicine, we need solid logistics systems in place that are both innovative and cost-effective.
“As medical costs increase, home care has the potential to significantly reduce expenses.”
Advancements in home care now allow kidney dialysis and sample collections for everything from colorectal cancer, DNA testing, biometrics, diabetes and more to take place in the privacy of the patient home.
For sample deliveries to test labs, this may require strict temperature controls and secure, intuitive packaging instructions the patient can easily follow. Add to this, of course, the need for timely product pickup and delivery.
Otherwise, packages that could contain blood, saliva and urine samples can be lost, spoiled or otherwise compromised and quickly undermine a steady trend toward greater patient control and convenience.
Home diagnostic and care solutions also can be adversely affected by humidity and bacteria so extra care must be placed on special packaging designed to maintain integrity. Different samples require different packaging, both in size and material.
Collection kits may include insulated thermal envelopes, coolers, thermal blankets and gel packs. As patient-centric trends continue to rise, expect the optimization of supply chains and packaging solutions to enhance direct-to and -from patient services to become even more critical and consequently, more innovative.
Lives are at stake
Optimized logistics must remain front of mind for organizations of all sizes. Managing varying weather fluctuations, transportation modes, packaging requirements and complex regulations is an art form for healthcare and life science shipments. But they’re vital considerations because valuable products are at stake – lives are at stake.
“Optimized logistics must remain front of mind for organizations of all sizes.”
According to the 2018 Biopharma Cold Chain Sourcebook by Pharmaceutical Commerce, the temperature-controlled logistics market will reach $15 billion annually, representing a 12.7 percent year-over-year growth. Between 2016-2022, Pharmaceutical Commerce sees an overall growth rate of 8 percent for cold-chain logistics.
As healthcare sciences grow, so too must safety protocols. There’s greater focus being placed on security around seals and tamper-evident closures, along with greater use of GPS tracking and geofencing to address recent Drug Supply Chain Security Act (DSCSA) requirements for drugs in transit. We’re also seeing chain of identity solutions based on integration of GPS, RFID and Bluetooth technology into packaging and linked to cloud-based tracking software.
Thousands of pharma and biopharma companies globally are researching, innovating and seeking out better, more efficient ways to safely package and transport their sensitive, high-value products. As they grow in number and importance, temperature-sensitive packaging and shipping trends must continually evolve to provide safer, more secure solutions that meet increasingly complex demands.
This article originally appeared in the International Pharmaceutical Industry’s 2018 Winter Journal and was republished with permission.
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