Sustainability concerns rank high with biopharma companies. According to the 2020 Biopharma Cold Chain Logistics Sustainability Survey by Pelican BioThermal (now known globally as Peli BioThermal), the biopharma industry is increasing its pace to prioritize sustainability in business and operational strategies. Nearly half of all respondents say that they always factor sustainability into cold-chain purchasing decisions, and 53% indicate that it’s very important to choose cold-chain packaging options that advance their organization’s sustainability profile. According to the survey, attributes that address sustainability needs include recyclability, weight reduction, and energy-efficient designs (1).

Many pharmaceutical products must be maintained at room, refrigerated, frozen, or deep-freeze temperatures. Preventing temperature excursions during distribution depends on maintaining the product within the required temperature range for the time it is in transit. Temperature-controlled packaging (TCP), or thermal shippers, typically consist of a coolant, insulating material, and outer shell. Designs can be one-way or reusable. Both formats are growing rapidly.

Kelly Cinelli, director of Marketing at Packaging Technology Group, reports, “We are finding the demand for single-use, curbside-recyclable shippers for direct-to-patient medication is at an all-time high.” However, she adds, “Reusable shippers also are in high demand due to the COVID-19 pandemic and supply-chain constraints.” 

A study of the pharmaceutical industry by Precedence Research estimates reusable packaging constitutes 74% of the market, and demand for it is growing faster than for single-use units (2). This demand for reusables is “due to the additional protections pharmaceutical products need including more robust packaging [and] stronger temperature control as well as the need for verification of temperature using a data logger or other temperature recording device,” says Mark Sawicki, president and CEO of Cryoport Systems.

Several suppliers cite sustainability as the major reason reusables are gaining market share. Ranjeet Banerjee, CEO of Cold Chain Technologies, reports, “A lot of customers have a very clear goal around reducing their environmental footprint. Reusables go a long way toward meeting that goal.”

“One easy way to reduce carbon footprint is to reduce materials,” explains Emilio Frattaruolo, vice-president of Innovation–Passive Systems at CSafe Global. Because reusables make multiple trips, less packaging waste is generated.

Reusable TCP also can offer cost and performance benefits. Although initially more expensive than a single-use unit, “the cost per use is equal or less,” says Frattaruolo. In addition, leasing programs can eliminate the capital investment required to buy shippers. Leasing also makes it easier to accommodate market growth or seasonal variations. “Our market research indicates that reusable TCP is significantly increasing its use of rental models,” reports Sean Austerberry, group research and product development director for Softbox Systems. He notes, “10% of spending was rental in 2020, and we estimate 25% of spending will be rental in 2024.”

Despite strong interest in reusables, there is ample demand for single-use TCP. “Single-use shippers are often a cost-effective solution in situations where a return/reuse program is either impractical or impossible,” explains Banerjee.

The decision between reusable and single-use depends on the application. Questions to consider include:

How many shipments go to that destination? How often?

How long will the shipment be in transit?

What temperature conditions will be experienced?

What preconditioning of refrigeration is required?

How is the shipment monitored and tracked?

What inventory management software is available?

For reusables, what percentage will be returned?

Is the end customer prepared to play its role in the return process?

Is there sufficient space and manpower available to prepare shippers for reuse?

What is involved in preparing the shipper for reuse (i.e., cleaning, inspection, and repair)?

For single-use, are end customers agreeable to disposing of the shippers?

How easy is the disposal process and how long will it be available?

Will the shipper chosen meet current and short- to medium-term needs?

Frattaruolo recommends mapping out the supply chain as the first step in deciding between reusable and single-use shippers. It is likely to be easier to recover shippers from distribution centers or intra-company operations. “Some remote areas don’t have the infrastructure to get reusables back … or won’t be receiving shipments [frequently] enough to justify a reusable,” explains Alex Arabea, marketing manager at Lifoam Industries, a business segment and subsidiary of LifeMade Products. Single-use also makes sense for many direct-to-consumer scenarios.

During the decision-making process, “It is important to understand that a reuse approach affords pharma manufacturers the ability to utilize higher-performance, more durable packaging material than is typically used in single-use shippers,” explains AeroSafe Global CEO Jay McHarg. He adds, “And since total cost is amortized over many turns, the investment in reuse can be quite comparable to single-use alternatives. Other cost factors to consider include possible fees, from shipper recovery to refurbishment. Conversely, there are cost items that reuse eliminates or reduces, such as stickers (printing and application), warehouse space, and sometimes even usage of freezers since, in the case of AeroSafe Global, we can supply preconditioned thermal material.”

If the decision is made to adopt reusables, time will be needed to plan and implement the recovery and refurbishment process. “A reuse model only works if the shippers are retrieved,” says McHarg. Another important consideration is that the buyer of the packaging usually is not the final recipient. “As such,” he advises, “retrieval programs must be tailored to the needs of the end user—clinician or patient—in both ease and simplicity.”

In situations where retrieval is not practical logistically or economically, a hybrid solution might be the answer. Dr. Joachim Kuhn, CEO and founder of va-Q-tec, explains: “va-Q-tec’s disposable solutions are manufactured for non-return, but due to their stability, they can be qualified for reuse. For example, our lightweight box, the va-Q-one, can be used several times for temperature-controlled transports when shipped to Africa. It only has to be requalified on-site.” 

Other important considerations in the review of reusable vs. single-use shippers include timing, product value, and stability range. Thus, a single-use design can provide adequate protection for a commodity product with a wide stability range and short hold time, but a higher performance reusable TCP is likely to perform better for an expensive, sensitive product with several days to travel. 

Consider the following pros and cons for reusable shippers in pharmaceutical packaging applications.

Equal or lower cost per trip if return rate is good

Can help meet corporate sustainability goals

Often consist of higher-performing materials

Tend to be more durable and resistant to damage

Costs increase if shippers or components are not returned

More work on the front end is needed to justify and identify the impact on internal and end-user processes

Must establish a practical process for return and preparation for reuse

End customer must be willing to participate in the returns process

Can be difficult to recover from direct-to-consumer applications

Requires inventory management system to prevent traceability and tracking issues

Custom configurations take longer to develop

Standardized sizes may not suit some payloads

Doesn’t generate costs/carbon emissions associated with return and refurbishment

Potential for on-site requalification at destination

Components can be environmentally friendly

Quick scale-up because no molding or tooling is required

Frequent decision making to determine correct packout for day/origin/destination/weather

Users must consider the specifics of their application when deciding whether the best option for TCP is a single-use or reusable model.

1. Pelican BioThermal, “Pelican BioThermal Survey Reveals Biopharma Companies’ Focus on Sustainability in Cold Chain Partnerships,” Press Release, July 28, 2020

2. Precedence Research, “Pharmaceutical Temperature Controlled Packaging Solutions Market Size, Share & Trends Analysis Report by Type (Reusable Solutions and Single Use Solutions), Application (Temperature-Sensitive Pharmaceuticals, Vaccines, Others) By Region, and Segment Forecasts, 2020–2027,” Market Report, www.precedenceresearch.com/pharmaceutical-temperature-controlled-packaging-solutions-market, accessed June 30, 2021.

Articles

Manufacturers seek more sustainable options for temperature-controlled packaging. 

Cold-Chain Shippers: One-Trip vs. Multiple Trips

Digital twins of manufacturing processes are being explored in pharmaceutical manufacturing for the benefits that can be harnessed from a real-time simulation of the actual process. In 2020, GSK partnered with Siemens and Atos (a digital transformation company and a long-time Siemens partner) to pilot a digital twin for their vaccine manufacturing process that modeled and controlled the adjuvant particle manufacturing process. The partners succeeded with the project goal of proof of concept, and GSK is now seeking to replicate the digital twin concept on an industrial scale for its vaccine development and manufacturing platforms.

“Industry 4.0 concepts, such as digital twins, are generally thought to be a good idea, but this project created belief that it can really be used in vaccine development and manufacturing,” says Matt Harrison, head of Sciences, Digital Innovation, and Business Strategy at GSK Vaccines. “Now we are developing a vision for using it for multiple products and platforms, and we are deciding which opportunities will best deliver value and have the most impact.”

A significant benefit of the digital twin was that the model allowed developers to better understand the relationships between process variables to control variability.

“Controlling variability allows us to improve quality and make product ‘right first time’ every time,” says Harrison. “The model and the high degree of process control also allows us to better predict and optimize product yield. The aim was to build the twin during process development and then use it in manufacturing. The digital twin is an additional ‘deliverable’ of the development process.” Doing the work to understand and optimize the process “

” in the digital twin, rather than actual experiments with real material in a lab or test facility, saves a significant amount of time, materials, and cost.

Although the team has not yet gone through a tech transfer between manufacturing facilities using the digital twin, in theory, the ability to model any differences in scaling up or moving from one facility to another will reduce tech transfer risks, says Harrison.

Factors in the success of the pilot project include strong backing from GSK leadership and good teamwork both between GSK departments and with partners Siemens and Atos, notes Harrison.

Another key to the project’s success was that we started small and focused on our goal of demonstrating the concept. The next challenge is industrialization—using digital twins at scale in both development and operations throughout the organization. This effort will require continuous improvement, and we expect we will need to continue to make software and hardware changes as we further develop our capabilities,” says Harrison. “Although there are certainly technical challenges ahead, the aim is for digital twins to become routine.”

Harrison asserts that digital twins will be useful not only for process control in the operation of manufacturing facilities, but for the future of vaccine development. “When designing a vaccine, manufacturability is crucial. Having a digital twin to develop understanding of the manufacturing process is a key benefit,” he explains.

Modeling the manufacturing process benefits both development and operations. 

Equipment and Processing Report Newsletter, July 2021 issue

Cold-Chain Shippers: One-Trip vs. Multiple Trips

GSK Pilots Digital Twin for Vaccine Manufacturing