A Conversation with Suppliers
There is a perception within the industry that manufacturers are reluctant to consider new and innovative packaging solutions. The PDA Letter reached out to the following representatives from two supply companies for their take on this: West’s Fran DeGrazio, Vice President, Scientific Affairs and Technical Services, Global R&D; and SiO2 Medical Products’ Christopher Weikart, PhD, Chief Scientist, and Eugene Polini, Principal Scientist, Technical Services.
West produces a number of packaging components, including alternatives to glass vials, as well as cartridges, prefilled syringe systems, self-injection platforms, etc. SiO2 has developed primary containers that combine the benefits of glass and engineered polymers, such as cyclic olefin polymers (COP), while eliminating their respective deficiencies. Using SiO2’s proprietary technology, a glass-like silicon dioxide-based coating is applied onto the engineered polymer container to provide the contact surface performance of glass with the manufacturing tolerances of engineered polymers.
The following is a transcript from phone interviews with DeGrazio, Weikart, and Polini.
PDA Letter: What are the top barriers to customers adopting new packaging technology?
DeGrazio: Quite often, our customers are very interested in our new innovations; however, the industry, in general, is very risk-averse. They want new innovations, but without a lot of change because managing that change can be a significant challenge for their organization. And certainly within large multinational organizations, the other challenge is seeking alignment with multiple decision-makers for a move to something they may not understand deeply. I think, at times, customers would rather work with what they know rather than take on the unknowns of an innovation.
Polini: I think the primary barrier is financial. It’s very expensive to change packaging and you’re going to have problems that outweigh the cost of changing. It’s a risk/benefit equation. How much does it cost to stay with the status quo? How much does it cost me to fix it? And if we fix it, what other problems will we have after that? Sometimes these fixes can be more problematic than the original ailment.
PDA Letter: How do you, as a supplier, address these concerns?
Weikart: We’ve got a very wide battery of tests that we do with our packaging—vial or syringe or cartridge. While I think the data speaks for itself, at the end of the day, [biopharmaceutical companies] want to see how our package behaves with the specific drug formulation. Often, we’ll do a proxy formulation with a protein or monoclonal antibody that’s sort of a surrogate to show them that the formulation and, of course, the protein are compatible. Of course, we’ll work with [our customers] to step outside of normal use testing—sort of guerilla tests—to go above and beyond what you’d find in normal use.
DeGrazio: If I remember correctly, the Corporate Executive Board has done research that shows that in B2B businesses, it takes about six people within an organization to agree upon accepting a new change or innovation.
Within an organization, you will always find some people who are more risk-averse than others. And depending on what roles they’re in, that can certainly present a challenge. Being able to ensure our customers that West can help them throughout the whole production cycle—from their evaluations to the development process and, finally, through their regulatory approval process—helps a lot to mitigate any concerns about risk.
Part of what we at West do is anticipate our customers’ needs. Then, we work actively alongside them, whether it be from an initial product support standpoint or by providing some services that may be able to help them through the process. For example, they may be interested in laboratory services because they want a better understanding of how a package or delivery system will work with their drug product, and we can provide that assistance.
Polini: What I’ve found is that they’ve been reaching out to us. These folks tried different packaging for their products and, for these products, especially the biotechnology products (stem cells, viral vectors, unusual storage conditions), they find that glass and existing plastic products don’t work. And then, sometimes through the grapevine or sometimes through our marketing programs, they find us and contact us. We’ve been very fortunate to find several of these folks have found that while nothing else worked, our product did.
PDA Letter: What do you wish your pharma customers knew about new tech they don't know?
DeGrazio: The issue is that a lot of times the first thing the customer does is measure a product based on its specifications. And although the specifications are important, of course, if you really look at some of these newer products and their capabilities, it’s more than just what can be measured in a specification. Other features and support around a product provide benefits to the customer. You need to think more broadly than just solely [about] the product itself, but around the holistic solutions that a supplier can bring to bear. For these reasons, I think we have to get the industry past [a focus on specification] to look more broadly at a product.
Polini: I’m a big believer in education. The more I can help clients understand what our product does and doesn’t do, the better off we are. I think there is a lot of misunderstanding with our clients and our products. Folks think we buy plastic vials on the open market and then coat them [but, actually,] we’re vertically integrated. We do everything, including injection-molding the product. We coat the product. We prep the product. We get it sterilized and we sell it as a ready-to-use product. So we do everything except make the resin itself.
PDA Letter: Are there times when it’s better for a customer or potential customer to continue using an existing technology?
Polini: Well, you know the old saying “if it ain’t broke, don’t fix it” comes to mind. Again, this is a for-profit-type industry that, if the costs of changing outweigh the costs of keeping the status quo, I think people will stay with it. [But] with regulatory agencies recognizing the benefit and beauty of our product, the regulatory support is crucial to our product being adopted. We have had some excellent interactions with the regulatory folks.
Weikart: Certainly, if there is no problem with the existing technology. Again, with this growing use of biologic drugs, these are very large, complex-shaped proteins—they’re a special needs molecule. And a lot of times the packaging is not good enough. Certainly, if it works in existing packaging, there’s no impetus or reason for them to change. But as far as I know, glass continues to break. I’ve not discovered a glass that doesn’t break. And that’s why we have combined the best attributes of plastic and the best attributes of glass into one package. Sometimes the risks are too high for [companies] to change, so I can understand why they’d want to stick with existing products. As new drug products are developed, however, each one is not created equally. They all have some misgivings that reveal themselves when combined with a package and, often times, that’s discovered later.
DeGrazio: The only time that I would say that makes sense would be in some very old drug products, such as ones we’ve seen where an extractable from an elastomeric formulation is actually helping to stabilize the drug product. Again, that’s certainly not the case with the majority of products out in the market. But we have actually seen cases where a customer may have tried to transition to a newer, cleaner, lower-extractable formulation and, when they did, they started having problems with the stability of their drug products.
I think what has happened, from an industry standpoint, is that someone gets comfortable with a product that they’ve been using for many years; however, there needs to be a recognition that the needs today, from [both] regulatory and quality standpoints, are quite different from years ago. You can’t just take a product that was intended for use 20 years ago and, magically, it becomes this brand new 21st century product for the future. It’s like saying that you have a black and white television and now want to change it to a color HD television because it’s 2017. That doesn’t happen. Ultimately, there are limitations to the products that have been around for many years. Plus, the fact [is] we can’t push a product to the point where it changes it substantially; then it’s no longer the product that it was originally. Ultimately, the customer needs to qualify components built for future challenges and just not rely on the fact that their historic product has always worked.
PDA Letter: Are there other ways your companies are reaching out to the industry?
Weikart: That’s certainly something we want to become increasingly involved in. At some of these conferences [Editor’s Note: Weikart presented at the 2016 PDA/FDA Joint Regulatory Conference], there’ll be special interest groups that assemble and get together to talk about specific issues or new packaging technologies. We’ve been involved in a number of those.
We’re also involved in some university relationships as well. One, in particular, is the University of Colorado in Boulder, where they have a conference every year in the summer that is focused on protein aggregates. You have the potential for an immune response from these aggregates in existing packaging. We’ve started to get more involved with those sorts of groups as well. We certainly do gravitate toward PDA because it’s a great venue for all to participate in.
DeGrazio: Absolutely. From a West standpoint, there’s a lot of educational activity. I’m engaged with the PDA, as are some other members of West. We also are active participants in other industry and standards organizations such as PQRI, ISO, and USP. I really see it as part of our role as a supplier to understand market and regulatory challenges and to help educate the industry.
PDA Letter: What is the breakdown in costs between using an existing packaging technology versus a new technology?
Polini: Right from the beginning, you have the cost of researching the new packaging. Doing all your due diligence, which is the extractables and leachables, you have to go through container closure integrity, and then you have to do the regulatory portion of it—you have to go back into your filing. And that can have ramifications with respect to new information needed for the new filings. Maybe this is an older product that’s been on the market for many years and maybe you didn’t do any leachables [testing] at all with your original filing. Now you’re going to have to go back in and the skeletons in the closet may reappear. I think there is a lot of reluctance to change something that is, for all intents and purposes, working. There may be some issues, but it’s when [they] have recalls and notoriety and huge expenses involved and their goodwill with the public is [affected], that’s when we see changes get made.
Weikart: Without getting into specifics around cost or price of technology, I think there is a perception that when you add a coating that is produced by a plasma-based technology, it certainly sounds expensive but, in fact, it’s not. The incremental cost of putting a coating on our containers is actually quite low and makes us very competitive with existing packaging that’s out there.
DeGrazio: That really comes back to total cost of ownership. It’s all about that aspect versus just looking at “I pay X for that product and I pay Y for this product.” What we do is help our customers focus on the overall value that a move to a new product can bring. Much of this value comes from overall efficiencies in the process.
Let’s say someone normally gets an elastomer component that is what we call “bulk.” They take it in, and they put it through a wash-and-sterilization process, and then they begin using it. There’s a lot of cost associated with that process—even in their infrastructure. Everything from capital equipment through validation and regulatory support needed for processing components—that’s not really core to their business of drug development and manufacturing.
Now, if you take the price of just a bulk, untreated component compared to the price of a sterilized component [ready-to-use], of course, the sterilized component is going to cost more. But you need to look at it in the totality of what it really costs a customer for that entire process and, ultimately, the potential for errors to be made during that process. Also, it’s important to consider the ongoing upkeep needed to assure a validated state to support processes that aren’t core to the drug manufacturing side of the business.