Research & Insights

Leading Minds Seminar 2018: Managing risk, Measuring Stability

Participants hear about USP guidance updates, industry best practices in cold chain
Sponsored by Elpro, a leading provider of dataloggers and other temperature-monitoring equipment, and Sonoco ThermoSafe, a leading provider of temperature-controlled packaging, the Leading Minds seminar is intended to be an information-sharing session among industry participants, especially when disparate parts of the pharma supply chain, from manufacturer to wholesaler to transportation provider come together. The meeting (June 6-7) brought about 75 participants together at Normandy Farm, a hotel/conference center in Blue Bell, PA.

A recurring theme of the meeting, chaired by Geoff Glauser, a consultant with the Biological Research and Development Authority (BARDA) of HHS, is the stability budget of drug substances—when they are part of a clinical trial; when product launch is approached; and when the full life cycle of the drug during commercial exploitation is experienced. Glauser notes that the Centers for Disease Control (CDC), a sister agency to BARDA, will allow for pricing premiums for CDC vaccine and drug stockpiles, when the manufacturer does the testing to ensure that the drugs can be kept stockpiled for extended periods of time.A variety of speakers, including scientists, pharmacists and engineers from Biogen, Merck, NIH and Elpro, explored the intricacies of measuring stability, making use of stability budgets in various stages of a cold chain shipment, and applying risk-based considerations to temperature excursions during shipments. Jeffery Carrico, PharmD, chief of clinical pharmacy and investigational drug research at HHS, noted that NIH sponsors upwards of 500 trials a year, and managing trial logistics is a challenge. “Everyone knows that the key factors are distance, time and temperature when it comes to maintaining a compliant trial logistics process, but verifying this in an auditable fashion is difficult,” he noted. One example: how to track a drug being tested, when the drug sample itself is blinded to investigators and patients.
Another range of factors affecting stability is not just measuring the effects of TOR (time out of refrigeration), but also freeze-thaw cycles, temperature spikes, and changes to a drug formulation between the clinical testing stages and final composition.

Chris Anderson, director of quality systems at Cardinal Health, and a member of the expert committee at US Pharmacopeia, gave an update of USP <1079>, Good Storage and Shipping Practices, which has been under an update cycle since 2016, and for which a draft version is going to be published in July. USP will be soliciting comments on the draft through the end of this year, and in February, a committee vote is scheduled for making the new version a final guidance. In general, says Anderson, risk-based approaches to managing storage and shipping practices will be a key part of the update.

Other sessions at the meeting included the challenges of controlled room-temperature (CRT) shipments, temperature monitoring protocols, and evaluating active versus passive shipping containers with a risk-based perspective. Dirk Rodgers, global regulatory strategist at Systech International, and blogger at, gave an update on blockchain as applied to pharma supply chains. Vishal Khushalani, director of global marketing at Sonoco ThermoSafe, outlined an evolving approach to the economics of reused cold-chain packaging, in which programs tailored to the shipping lanes, the types of packaging materials, and the shared responsibilities of the shipper and the packaging provider, can be worked out.

The meeting concluded on the second day with guided tours of a Sonoco ThermoSafe facility, and an Elpro user group session.Leading Minds is planned to be an annual event for the Sonoco ThermoSafe / Elpro collaboration. More information is available here.

Original Publication: Basta, Nick. “Leading Minds Seminar 2018: Managing risk, measuring stability.” Pharmaceutical Commerce, 13 June, 2018,

Sonoco ThermoSafe and Cathay Pacific Cargo Launch Global Partnership to Lease PharmaPort 360 Temperature Control Bulk Shippers

Sonoco ThermoSafe, a leading global provider of temperature assurance packaging, and Cathay Pacific Cargo, one of the world’s largest air cargo carriers,  announced a global partnership agreement for the leasing of the PharmaPort 360  temperature controlled bulk shipping container. The agreement enables pharmaceutical shippers to lease PharmaPort 360 containers directly from Cathay Pacific Cargo.

The PharmaPort 360 utilizes proprietary hybrid technology to provide extremely precise, long duration +5C temperature control for transporting high value cargo for the world’s leading biopharmaceutical companies. Once charged, the PharmaPort functions like an active temperature controlled container without the energy consumption, heat discharge or temperature variability of other compressor-based technologies. The PharmaPort’s hybrid technology allows it to operate on battery power substantially longer than competing active units used for bulk air shipments, and it also eliminates the need for refrigerated trucks for lengthy truck lanes. Additionally, the PharmaPort 360 is the only container in the industry that contains a fully integrated, FAA (Federal Aviation Administration) approved telemetry system, providing real-time, cloud-based data on payload and ambient temperature and key mechanical components, precisely synchronized with GPS location.

Cathay Pacific Cargo, which is CEIV-certified, is the first carrier in the world to sign a direct contract with Sonoco ThermoSafe. The PharmaPort 360 will provide another active container solution to the impressive Pharma LIFT portfolio of Cathay Pacific Cargo, offering more choice and service to customers worldwide.

“Sonoco recently topped the list of Fortune’s World’s Most Admired Companies in the packaging sector. Its reputation for quality perfectly aligns with our own high standards for service delivery,” said Frosti Lau, general manager of cargo service delivery for Cathay Pacific Cargo. “We are delighted to have this unique and world’s-first partnership with Sonoco ThermoSafe, and we are confident this collaboration will provide our customers with a consistent solution for the transportation of vital and life-saving pharmaceutical products.”

“We are delighted to partner with a high-quality and service-oriented carrier such as Cathay Pacific Cargo which has one of the most extensive networks in the world. This partnership enables the pharmaceutical supply chain to now directly lease from Cathay Pacific Cargo the best-in-class PharmaPort 360 temperature control containers on a one-way lease basis across the Americas, Europe and Asia-Pacific regions,” said Vishal Khushalani, director of global marketing & business development for Sonoco Protective Solutions. “Additionally, Sonoco’s 300+ global locations allow the Sonoco ThermoSafe division to efficiently expand the depot network for leasing PharmaPort units across the globe.” Visit to learn more.

ChillTech®: A Reusable Range of Shipping Solutions for Temperature-Sensitive Pharmaceutical and Biological Shipments


We’ve launched a new range of reusable, universal solutions for the pharmaceutical and biologics markets. ChillTech® is a pre-qualified range of 2°C to 8°C PCM systems providing exceptional temperature control from 2 days up to 6 days for payloads from 4L to 40L. ChillTech® utilizes Sonoco ThermoSafe’s patented Zero Bench-Time® technology, where systems can be packed-out straight from the freezer, saving customers space, time and money.

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Product Launch: Cost-Effective Range of 48-Hour Pre-Qualified Temperature Controlled Shippers

Certis NEW Hero

We have expanded the Certis® brand of one-way shipping solutions to include a 2-day platform for the express distribution of pharmaceutical and biological products. Just as in the award winning* Certis® 3-Day & 5-Day Platform, the Certis® 2-Day Platform utilizes the same pack-out for 2-8°C, 15-25°C and frozen shipments. Using just three types of refrigerants and four shippers to create 12 solutions, the Certis® 2-Day Platform maximizes the number of solutions while minimizing the number of components. The new platform is sized to accommodate 7, 13, 27 and 56 liters of product. Each of the new solutions feature a year round pack-out designed for use in both hot and cold seasons.

“When designing the Certis® 2-Day platform we focused on minimizing overall cost of ownership. Not only are these new solutions cost effective, but users will also see additional savings through operational efficiencies. With the use of our unique ZERO Bench-Time® technology our customers can immediately pack-out each solution and reduce their assembly time and space requirements,” said Ben VanderPlas, global product manager. “In combination with our Certis® 3-Day and 5-Day platform of solutions, the Certis® product line now offers a complete portfolio of temperature ranges, durations, and payload sizes.”

The Certis 2-Day Platform is designed to Sonoco ThermoSafe’s ISC Regional™ ambient temperature profile for short term shipments. Available in both U.S. and European facilities. Visit to learn more.

*2016 Cold Chain Global Forum Excellence Awards – Most Innovative New Cold Chain Technology of the Year, Winner for the Certis® 3-Day & 5-Day Platform.

Sonoco ThermoSafe Expands Range of LD7 Pallet Shippers For Temperature-Sensitive Bulk Air Shipment


Sonoco ThermoSafe, a leading global provider of temperature assurance packaging,  leverages award winning technology to expand its line of pallet solutions with the launch of the LD7 Half PAG pallet shipper. The Half PAG solution is designed to ship multiple pallet loads, whilst reducing the cost and operational complexity of bulk shipments by optimizing the use of aircraft ULDs (LD7 air pallets). The Half PAG is available for 2-8°C or 15-25°C temperature ranges with durations in excess of five days. Each solution has a universal pack-out design to be used in both hot and cold seasons while also accommodating the demands of cross-hemispheric shipments.

“The new Half PAG pallet shipper features the same award winning* and innovative patented and patent-pending design technologies used in the Quarter PMC, most notably ConvecTECH™ and the unique interlock L-shaped panels. ConvecTECH™ technology, maximises the natural convection to eliminate side refrigerants, maximising payload space, reducing shipment weight and simplifying packing procedures. Additionally, the unique interlocking L-shaped panels eliminates corner leaks and drastically reduces edge leaks,” said Ben VanderPlas, Global Product Manager, Sonoco ThermoSafe.

LD7 Half PAG is part of a wider family of space and weight optimized pallet solutions, designed to offer loading and carrying compatibility on modern passenger/freighter aircrafts. Please visit for additional information on our range of temperature-controlled packaging pallet solutions.

*2016 Cold Chain Global Forum Excellence Awards – Most Innovative New Cold Chain Technology of the Year, Runner Up for the Quarter PMC Passive Pallet Shipper.

Sonoco ThermoSafe Survey Reveals The Current And Future Trends In The Clinical Trial Supplies Market


Sonoco ThermoSafe has in partnership with Arena International Events Group and Berlinger & Co. AG, today announced the results of an industry survey entitled “Assessing the Current and Future State of Clinical Trial Supplies”. The survey was co-developed by an advisory panel of industry experts from clinical operations, clinical trial supply logistics and packaging, as well as bio-pharma manufacturing and supply chain organizations.

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Sonoco Makes Fortune “World’s Most Admired” List Again

fortune17Sonoco is pleased to announce the Company ranks second overall in the packaging sector on FORTUNE’s World’s Most Admired Companies list! Sonoco ranked first in its industry in both Financial Soundness and Long-Term Investment Value and second in Innovation, Social Responsibility and Global Competitiveness.

FORTUNE’S World’s Most Admired Companies list is the definitive report card on corporate reputations. Executives, directors and analysts rate companies in their own industry on nine criteria, from investment value to social responsibility. A company’s score must rank in the top half of its industry survey to be listed.

See Sonoco’s full profile here.

Learn more about all of the Most Admired listings here.

Shipping 800,000 Years of History…


Shot by Megan Geuss

Shipping temperature sensitive items has always proven to be a tough thing to perfect.  There are so many variables: ambient temperature, shipping lanes, travel conditions, delays, and much more.  Now, imagine having to ship samples of ice cores drilled from the South Pole that can date back 800,000 years.  Those are the kinds of challenges faced by the scientists at the USGS National Ice Core Lab in Antarctica.

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