Supply Chain

Q&A: MIT Operations Researcher Talks COVID-19 Vaccination Hurdles

KEREN SOOKNE, DIRECTOR OF EDITORIAL CONTENT

Around the world, scientists and citizens alike are hoping for a COVID-19 vaccine. Dr. Anthony Fauci is “cautiously optimistic that we will have a vaccine within a reasonable period of time, not only from Moderna, but from other companies too.”

Healthcare Packaging spoke with MIT’s Dr. David Simchi-Levi, an operations research scientist who has thought through some of the challenges of preparing for the vaccine rollout. His research currently focuses on developing and implementing effi cient techniques for logistics and manufacturing systems. HCP: What do you feel is that fi rst hurdle that people are overlooking in distributing an effective vaccine? Dr. David Simchi-Levi: The vaccine rollout has many diff erent challenges. I’ll start with some of the observations about the vaccine development. Part of the challenge is making sure that we focus on the safety of the vaccine itself in providing long-term protection for all the people. There are several technologies considered for the vaccine. When we talk about product, we don’t know which one will be

successful just yet and we don’t have many examples where the are at high risk? Should it go to medical staff fi rst because they are scientifi c community has been successful in developing vaccines exposed? Should it go to young people because they interact a lot for infectious diseases in the last 100 years. with others? So which one will be successful? And once you develop one, it’s All of these questions are on the table, but for now the main question typically a sequential process. You start in the lab, you test on is, for all the steps that normally follow a sequential process, how animals, then you test on people in several do we do many of them in parallel? trials, then you create specialized manufactively, you need to provide storage to make sure that the vaccine tiveness if stored at the wrong temperature. So packaging, distribution, and the temperature-controlled supply chain are a critical gets it and who doesn’t? Should it go to elderly people because they turing processes. It’s a very linear process HCP: What are your thoughts on effecthat can take several years. The problem is tive and ethical allocation? that we don’t have time now, and we need DSL: It’s a critical question: What is that to do many of these steps in parallel. And allocation mechanism? How can the federal challenge number one is that we don’t know government, health insurance companies, which technology will be successful so we etc. make reasonable allocation decisions don’t know which manufacturing process that benefi t the population as a whole? to invest in. This is exactly what my team at MIT is working on now: a model that tries to identify HCP: And with different manufacturan eff ective allocation strategy that will ing processes, there could be different allow us to improve the eff ectiveness of the supply chains? vaccination, when not being able to give it DSL: Exactly. The Gates Foundation is now ↑ MIT’s Dr. David Simchi-Levi. to everyone. We need to vaccinate as many building or investing in the seven most as 70% of the population, while making sure promising technologies, because they don’t know which one it will there’s no spread of the epidemic because we couldn’t get to everybe. You may not use all of them because maybe only one of the techone. nologies will be eff ective. My team studies what we need to decide, what is the best way from HCP: How does packaging come into play? government here in the U.S. is looking into this, the EU, the Chinese DSL: The second challenge is that in order to use the vaccine eff ecgovernment—everybody’s looking at the same issue. itself does not degrade. The entire process has to be controlled, just HCP: We hear a lot about “a vaccine” or “a treatment,” but as with any drug. Vaccines are extremely sensitive. They lose eff ecwhat are some of the supply chain considerations if there’s a part of the challenge. Workforce Issues In addition, each dose, each unique vaccine requires all sorts of HCP: With the sheer size of the target market (essentially, components that are low-cost, but we don’t have the supply. We everyone) do you foresee workforce shortages either in drug don’t have the ability to produce a package for the product right manufacturing or with healthcare workers? now: vials, stoppers, needles, caps and so forth. Making sure that DSL: This is another important issue. It’s both in healthcare we have the inventory of specialized glass for vials domestically is and in manufacturing because in the manufacturing process, a challenge. These components are produced mostly in China and you need to maintain social distancing because of the virus in India. For example, there is only one company in North America which reduces productivity. You also need to make sure that able to produce needles in large scale. people have core skills training to be able to move from one You can expect that—and this is not politics—we’ll see some countechnology to another. Remember that we don’t know which tries blocking, say, a shipment of this type of supply because they technology will dominate, and there are seven different factowant to keep it for their own citizens. So logistics is going to be a ries in the Gates example. You need a workforce that is capable challenge. of switching from one to another, depending on which one And fi nally, no matter what we do, there will not be enough supply is successful. I think this becomes really a critical part of the to cover the demand, so there will be a need for a decision: who supply chain solution. a community point of view to allocate the available inventory. Our

combination of drugs that works versus one silver bullet? DSL: If there is one silver bullet that is successful, one advantage is that we can scale very well, but the disadvantage is not having enough capacity. If only one is successful, six of the manufacturing facilities that, say, the Gates Foundation is focusing on will not be able to produce this one silver bullet, unless they build flexibility into these manufacturing facilities to change from one technology to another. That will allow us to scale very quickly once we know which technology is effective, but flexibility does not come free… there is a cost associated with that. I’m not sure what exactly the plan is, but flexibility is one important element that can help us scale very quickly if we are willing to invest in it.

HCP: Any comments on vaccine traceability? DSL: One thing I’ll note is that people talk about the use of blockchain as a way to allow you to trace the product and origin and make sure that it is not counterfeit. I’m sure traceability technology will be one part of the solution.

HCP: How might climate change and the carbon footprint of manufacturing and logistics tie into the effort to reshore operations? DSL: This is a very interesting topic. We know that for a lot of these manufacturing processes, you need certain chemicals and a lot of these chemicals are now produced, not here, but in India and in China. People often say the reason they’re produced oversees is to reduce cost. This is only part of the reason. The second driver of the move of these chemical manufacturing activities to India and China is because chemical manufacturing processes are highly polluting. And so the move to Asia in part is driven by environmental concerns. Now, if companies say they’re moving API manufacturing to North America or Europe, this will increase cost, but the issue is that nobody’s going to agree to build these chemical manufacturing facilities that will be highly polluting. So you need clean chemical manufacturing processes, and that requires time and significant investment. Who will make this investment? Is this going to be the federal government, or private investors? The European Union may have one opinion and the U.S. federal government here may have a different opinion. These manufacturing challenges are not only about the cost. It’s a lot about environmental issues. China is not relaxing their effort either. They’re looking for clean manufacturing processes. So if China figures this out and has a low cost, it will be very difficult to motivate the move to North America. That’s why I’m saying it’s time and investment. People will be looking for reusable packaging materials. But to me, even before that, there are issues with pollution and the fact that the U.S. is already coping with a shortage in the specialized glass needed for the vials. Even before packaging exists, these are important challenges that you need to address today, in order for packaging to be there five months from now.

Supplier Side: Using Automation to Fast Track COVID-19 Vaccine Production

On the heels of the FDA creating the Coronavirus Treatment Acceleration Program (CTAP)—an emergency initiative aimed to support clinical trials that are testing new treatments for COVID19—Honeywell has introduced Fast Track Automation, a technology package that can help accelerate the production of vaccines.

Using a combination of its proprietary automation and process technologies for the life sciences industry, Fast Track Automation enables vital vaccines, treatments, and therapies to move from regulatory approval to full production in as little as two months, depending on process requirements, the company said.

The offering brings together the cloud, virtualization, batch software, remote asset management from a data center, and the flexible assignment of computing power. The technology combination prepares manufacturing automation designs in parallel with clinical trials, designed to ensure production is ready to go once a medical therapy is approved.

Specifically, the set up incorporates process automation elements that can be configured in a virtual environment, then implemented rapidly once a therapy is approved and ready to be produced for public distribution. Manufacturers can even use the system to digitize manual steps during clinical trials to better consolidate and analyze data and more seamlessly prepare electronic submissions for regulatory body review and approval, using this data to prepare final production automation design.

Fast Track Automation is a direct response to the global COVID19 outbreak. According to the company, at the point in time when clinical trials are nearing completion, the ability to rapidly pivot and scale up to meet production demand will severely test existing technology infrastructures. “Our solution allows for end-to-end manufacturing process and data visualization, providing realtime visibility and predictive insights while offering benefits like enhanced audit-readiness and data integrity, minimized regulatory risk, increased operational efficiencies and reduced rejects and waste,” said Cynthia Pussinen, vice president and general manager, Life Sciences, Honeywell Process Solutions. Fast Track Automation, available now, can be quickly scaled up or down depending on needed changes and demand. —Stephanie Neil

Smart Supplement Shipper is LetterboxFriendly, Sustainable

ANNE MARIE MOHAN, SENIOR EDITOR, PACKAGING WORLD

TOP THREE TAKEAWAYS

1. Brain health company launches its D2C supplement product in a slim bottle and shipper.

2. The bottle and shipper are made from bio-based materials that together measure less than one inch deep.

3. The clear 60-ct bottle has a soft, asymmetric ‘thought bubble’ shape.

Brain health and mental wellness supplements company Heights has pioneered a new dimension in e-commerce packaging—and it’s only 25 mm, or 0.9 in., deep. The impossibly thin shipper, with an even slimmer, 23-mm bottle inside, was designed by the London-based company to easily fit through a UK letterbox-style mailbox.

Being unique is not new for this startup company; its distinctive supplement uses “capsule in a capsule” technology whereby the dry ingredients are in one capsule that is suspended in an outer capsule of Omega 3 oil. Says the company, “Most vitamins need to be taken with food or a fat-soluble substance. Because ours comes ready-made inside an Omega 3 oil and dissolves slowly in your lower intestine, you get more of the nutrients reaching your bloodstream than in traditional pills, which break down too early to be effective. An added benefit to this—no nausea.”

Specifically designed to give the brain the fuel it needs to improve its health and performance, the easy-to-swallow “smart capsules” are made from natural ingredients—among them, B12, blueberry

↘ Foregoing the usual cold, sciencelike design language used by supplement brands, the clear 60-ct bottle for Heights’ supplements has a soft, asymmetric ‘thought bubble’ shape and is flat on the front and back to reveal distinctive capsules inside.

extract, and 16 other essential vitamins—in the most biologically active form and are augmented with educational content for consumers on how to optimize brainpower.

Says Heights co-founder Daniel Murray-Serter, “We use all natural nutrients and no synthetic fillers or caking ingredients and track your journey with us from day one, sharing insightful content from the world’s leading experts to help coach you on your journey to mental wellness.”

Heights began working on the package design in early January 2019 with design firm Pentagram. The project was led by Pentagram partner and industrial designer Jon Marshall. Explains the firm, because Heights is a D2C brand, the design of the bottle was

↖ The slim, e-com shipper comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature.

driven by two factors: It needed to be highly distinctive in order to launch the brand, and it also needed to be less than 25-mm thick to fit through the letterbox for efficient delivery and a great customer experience.

Adds Murray-Serter, “We were 100% committed to fitting through the letterbox for environmental reasons, accessibility, and the ability to send internationally as a large letter. That was the starting challenge for the design project in general.”

Foregoing the usual cold, science-like design language used by supplement brands, the clear 60-ct bottle for Heights’ supplements has a soft, asymmetric “thought bubble” shape and is flat on the front and back to reveal the distinctive capsules inside. A narrow neck tapers into the main body of the bottle, making it easy for consumers to remove the daily dosage of two pills at a time, while ensuring the bottle can be easily filled during the packaging process.

According to Pentagram, the design team used a combination of software simulation and extensive development and prototyping with the (proprietary) blow-molding manufacturer and with the bottle filling line to achieve the distinct bottle shape.

In order to minimize the shipper’s carbon footprint and stay within the 25-mm overall package thickness for economic delivery, Pentagram engineered the special shipping box so that it adds just 2 mm to the thickness of the product. The package comprises a hinged tray fitted with movable inner trays that securely hold the bottle and product literature and can be swapped out for future Heights’ products.

Besides being letterbox-friendly, the entire package is also very eco-friendly—a must for Heights. “The packaging had to be bestin-class for sustainability because we have always planned from day one to qualify as a B Corp,” explains Murray-Serter.

While the initial bottle design was tested and pre-launched using PET plastic, the final, commercial-scale version uses bio-based polylactic acid (PLA). The shipper is constructed of sugarcane-based pulp, and the information inside the package is printed on recycled paper.

Heights launched the e-commerce product in the mail slot-compatible shipper in Nov. 2019. Says Murray-Serter, “The response has been phenomenal. We’ve had customers tagging themselves in places like the Alps, on beaches, and as far as Easter Island, just to show off the amazing bottle design.”

For the latest in packaging design and materials, make plans to visit PACK EXPO International/Healthcare Packaging EXPO 2020. For more information visit packexpointernational.com.

Virtual FATs: New Guidance Addresses Critical Need During COVID-19 Pandemic

JIM CHRZAN, VP OF CONTENT AND BRAND DEVELOPMENT

The OpX Leadership Network released best practices and leadership guidelines for executing virtual factory acceptance Virtual FAT for a Blister Machine tests (vFATs) to address the changing operational landscape Romaco is one supplier taking a new approach with FATs due brought on by COVID-19. to customers’ travel restrictions. Their fi rst live remote FAT for

This addendum to the existing Factory Acceptance Test (FAT) a Noack 623 blister machine was recently completed at the work product tackles how to most eff ectively use communication Romaco manufacturing facility in Karlsruhe, Germany. The and connection technologies to allow consumer packaged goods machine—purchased by a pharmaceutical producer in south(CPG) companies to interact remotely with original equipment ern China to seal ultra-lightweight gelatin capsules in alumimanufacturers (OEMs). num-aluminum blisters—can now be shipped and placed into

“The pandemic has required new methods be established for operation as planned. executing FATs, which are likely to become standard procedures The vFAT took a half a day. Personnel at the customer site in the post-pandemic ways of working. This document provides in China monitored the functional tests closely during the live the guidance both CPGs and OEMs need to successfully implebroadcast. The project manager in charge at Romaco China ment these new processes,” says Bryan Griff en, director of industry was at their side to translate questions and provide answers. services, PMMI. “The OpX Leadership Network’s unique perspec“The only things we have to do without when carrying out digitive blending CPG and OEM input makes these best practices crittal acceptance tests are the meals we normally eat together ical learning for anyone interested in virtual FAT options.” and of course the group photo standing next to the machine

The OpX Leadership Network was founded in 2011 by PMMI, The after it’s passed the FAT,” says Markus Frey, area sales Association for Packaging and Processing Technologies, to ensure manager at Romaco Pharmatechnik GmbH in Karlsruhe. “We CPG companies and OEMs are well-connected and well-prepared intend to catch up on all of that later on after the pandemic is to solve common operational challenges, make smarter decisions, over.” and achieve operational excellence. Romaco has other vFATs planned, including a blister line with There are two parts to cartoner and case packer for a French contract packager and both the FAT work product packaging lines destined for a pharmaceutical group in the U.S. and vFAT addendum–the —Keren Sookne playbook and an editable checklist. Both the FAT and vFAT work products, as well as other operational solutions, are available for free download at OpXLeadershipNetwork. org/projects (FAT downloads are listed under Capital Projects).