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Manu Kizenkere, Associate Director of Packaging Engineering at Gilead, discusses the changes in pharmaceutical packaging over the years. Packaging is now seen as an important part of product design and research, and there is a greater emphasis on packaging materials and automation. The pharmaceutical packaging landscape includes plastic bottles, blister packs, vial kits, pre-filled syringes, and auto-injectors. Bottles are preferred in the US, while blisters are preferred in Europe and Japan. The main challenge facing packaging developers is patient adherence, followed by project timelines and sustainability. Access to information is also a challenge. Hello and welcome to European Pharmaceutical Reviews podcast. I'm Caroline Peachy. I'm the editor of European Pharmaceutical Review, and I'll be your host today. In today's episode, we're talking about pharmaceutical packaging, and I'm thrilled to be joined by Manu Kizenkere, Associate Director of Packaging Engineering at Gilead. Hi Manu, thank you for joining me today. Hi Caroline, happy to be here. Fantastic. Right, before we delve into all things packaging, could you tell us a little bit about yourself and your career in the pharmaceutical industry? Absolutely. I have been in the pharmaceutical space, medical device space, for about 17 years, specific to packaging. My first half of the career was medical device and drug discovery device companies like Boston Science & Effects, Nathan Nephew, Medtronic. My initial pharmaceutical exposure began with Corning Life Sciences. Corning, as most of might know, is a drug discovery company. They do have a separate vial glass manufacturing company. They invented a glass called Valor Glass. So I supported that and I got a fantastic experience working with Corning there. But my core for my experience began with Bluebird Bio in gene therapy space, where I started a packaging technologies department under supply chain. I had an amazing team and an amazing leadership there. Our department there managed packaging designing, packaging validation, more focused on core chain and also cryo bags, artwork labeling support. We did all in all for commercial and clinical packaging at Bluebird Bio. Then I moved on to Allylum Pharmaceutical in an interesting role. It was a supply chain QA role, but focused on pack and label. Allylum had two commercial products that we supported from more commercial supply perspective, country launches, CMO 3PL qualification. When I say CMO, contract manufacturing organization, you can treat them as contract packaging organizations as well. So we also were supporting a late stage combination product for Allylum as well. So then I moved on to Kala Pharmaceutical and took up on an external manufacturing role, which was again more specific to packaging, labeling, sterilization, and serialization. I managed a bunch of CMOs there, dealt with a lot of equipments. So I had a very good experience there. Now at Gilead Life Sciences, my team supports about 20 plus clinical programs and work with various packaging here, like vials, bottles, secondary packaging, combination products, label stock selection, you name it. So I'm in the middle of it as we speak. So I'm very excited how my career has forged. Thank you very much, Manu. How would you say packaging and the packaging industry has changed since you started working in this sector about 15 years ago? Yeah, absolutely. There's been a huge change, right? Packaging, even pharmaceutical and medical device, is a slow-paced environment, but it's not. There is a lot of dynamic changes happening, right, with supply chain regulations, which has a direct impact on packaging. But initially what I have noticed, Caroline, is that packaging, in my opinion, was an afterthought and an aftermath. However, that perception has changed with time, right? Companies realize the importance of packaging. They involve packaging at very early stages of designing and research, because packaging is a part of the product. Basically, I think packaging has evolved a lot. Now package engineering is a well-known trade. Many universities across the world offer that as a program, and it has enhanced and expanded so much. Even if you look at different companies, there are a lot of packaging engineers and separate departments, and I have seen where there are separate commercial packaging department, separate clinical packaging department, based on the size of the companies. So, I want to emphasize on the perception of the packaging has changed big time over the industry. I touched a little bit upon the regulations. Regulations have become more specific, and it keeps on changing, right, as the market changes, as the environment changes, as we learn new things. With COVID pandemic, many things changed with regulations. We had to kind of accustom real quick to the supply chain, and also there were risks that came out of that. So, it's a very dynamic field, which has changed 15 years is a long time. The other biggest change I want to point out is packaging automation. I can't emphasize enough, like as we talk through this podcast, I'm going to emphasize more on this, because this is tied to artificial intelligence, machine learning. Packaging automation has grown so much. There was a lot of manual operations initially. Now, even the manual operations are getting converted into a semi-automation, if not fully automated, depending on the programs. The contract packaging organization have increased as well. That's another area where there was not a lot of options before, but nowadays there's so many options, depending on your product need, you can pick and choose your contract packaging organization or contract manufacturing organization. There are some organizations who manufacture a drug product, a formulation, and also package. Their capabilities have expanded unbelievably, and they have implemented the new technologies. There's a lot of competition in that field. One last thing I want to mention on this question is that enhancement of packaging material. That is another field where there has been a lot of research done by the flexible companies who have come up with unique innovative designs based on the user need, patient's need. There has been a lot of innovation in packaging design itself, right? Maybe a primary package, secondary package, or even in coaching packaging, which is kind of underrated. Fantastic. We've got lots there, and I'm sure we'll delve into some of the topics you've mentioned, automation, AI, a bit later on. Sticking more broadly, can you tell us a bit about the pharmaceutical packaging landscape and what it looks like today? The pharmaceutical landscape today, more from oral solid dose perspective, bulk of the pharmaceuticals that are oral solid dose still rely on the plastic HDPE bottles, right? These are legacy bottles. Some of the things are so simple, it doesn't have to change, and they're very effective, right? So, you still see a lot of HDPE bottles with traditional desiccants, right? Some of the tablets, which are moisture sensitive, use desiccants. So, it's plastic canisters we use. There are special cases where dosing is complex. That's where, like, the blister pack comes into play. What I have observed from landscape perspective, Caroline, is that in the U.S., bottles are preferred compared to blisters, but in Europe and Japan, blisters are preferred. So, that's an interesting observation primarily used today. There have been some innovations, which we'll talk more about it, but primarily I've seen bottles and blisters. The vial kits, pre-filled syringes, and auto-injectors are also gaining a lot of traction, with biologics being one of the main focus in the coming years, you know? And then there is cell and gene therapy, where we use cryobags and an ecosystem, which kind of supports the cryobags with cold chain packaging. We have different cold chain packaging designs, which supports dry ice, frozen equipments, PCMs, phase change materials, which help to retain the cold atmosphere for the minus 20, minus 40, up to 40 C control temperature products, and ultra-frozen liquid nitrogen support with minus 140 C products. Thank you, Manu. I wondered if you could maybe weigh up the benefits of, you know, bottles versus blister packaging. Yeah, absolutely. So, both have its pros and cons, right? With bottles, it's very simple. It's cost-effective compared to blisters, right? But blisters, you can be fancy by it's more patient interactive, right? So, I think it's based on your needs, and also geographical preferences sometimes, company preferences kind of comes into play. Some of the companies who have used bottles, from sustainability perspective, there are some efforts that have been done in both in bottles and blisters. But as of today, we are seeing this kind of trend in the US and Europe. What would you say is the single main challenge facing packaging developers today? So, basically, packaging patient adherence is one of the biggest challenges as of today, right? Starting with the clinical setting, you want good clinical data. For that, patients need to stick to their regimen and take the appropriate dose on time. So, that has been a huge issue. Even the product, well, once it gets commercialized, that space needs a lot of emphasis moving forward. But there has been a lot of efforts that have been put together. So, that's one big challenge in pharma space, where when you're designing the packaging, it's a multi-facet, right? You need to work with your clinical ops, you need to work with your quality team, your patient ops, patient safety, to kind of emphasize this patient adherence. The second challenge would be just the project timelines and the project timelines itself, right? Because there are so many moving projects, and sometimes you just don't have time to give the details, deep support for a particular project. You tend to utilize what has been working for you, right? But I think that you really need to keep up with the industry and the technology. The biggest push recently has been sustainability, and it is difficult to come up with solutions, cost-effective sustainable solutions. For instance, the PVC blisters are the most cost-effective. It's machinability, it's flexibility. It's very hard to replicate that, right? So, it's difficult to replace packaging like that, but there has been a lot of efforts through that. The other thing I want to say is, which is kind of a hidden thing, is access to information. Sometimes you have a problem at hand, and you don't have a lot of access to information. What's out there? How can I fix this particular issue, you know? So, engineers tend to spend a lot of time in brainstorming, trying to find solutions, so that is a challenge as well. And also, on the same lines, even though you come up with an innovative solution, right? It's difficult to implement it from internal resistance. Internal resistance meaning, for a good reason, right? You might have some resistance from your leadership. You might have generally cost resistance, right? Because it wouldn't support what you want to implement. And there are some financial implications for qualification validations and time, which goes with that. That's a big push or a challenge for packaging engineers and developers. And the compatibility itself, right? Even though you come up with a new material, you still have to do your due diligence on, is this particular material compatible with your drug, your formulation? So, that's another key aspect for you to consider. And changing regulations, right? So, that's another big aspect where you need to keep up with your regulations, and if different countries have different regulations. So, I think that keeps you on your toes. So, there's so many things going on that you need to have a structure to kind of tackle all these challenges. So, Manu, what would you say are the top three considerations for packaging developers? With this changing world and dynamic environment, it's very important for packaging developers, packaging engineers to immerse themselves in innovation. Introducing innovation slowly into your ecosystem is very key because we need to keep up with the technology. It's easy to kind of lean back on what you have been using for a long time, but there are challenges, right? There are financial implications when you're trying to induce a new innovative design or a technology into your ecosystem. So, it's very important for you to focus and have innovation implemented in your packaging design or in your processes, right? The second thing I want to say is automation and AI. When designing any packaging systems, it's very important for you to consider how it's packaged. Are we using, what kind of equipment are we using? Is it going to be a semi-automation or a manual pack or a fully automation packaging? What kind of cartons will be used? Is that compatible with an automation system? Can that be used for both manual and automation system, right? So, it's very important to take the automation into account because it's inevitable that we are going to move towards automation. If not, we have already moved towards it. The third thing is more like the standardization and platform approach for your products. Like if you have blister packs or bottles or combination products, think of standardizing them so that it is easy for you for other products to implement that kind of standardization. Manu, what do you think 2024 will bring for the packaging industry? As we were talking, I think there's a huge push for sustainability. I can't emphasize enough about sustainability. Many companies are moving away from thermoform trays, any kind of plastic they could reduce. They're highly and heavily looking into it. In fact, in our company, we have replaced even the utensils with wooden spoons and forks. So, it's very important that sustainability should be given a high preference when you're designing. Well, in some cases, it's not possible as of now. We are limited from technology perspective, right? But I think sustainability will be a big one in 2024. And there are some proven and tested packaging systems, right, which are glass vials and bottles, which are legacy product. I see that they will still continue going into 2024. There is no reason to change those, right? There could be some advancement, but it's simple and it works. So, I don't see any changes there. There has been a trend in the increase of biologics, Caroline, leading into penetral, prefilled syringes, AIs, vials. The increase of these packaging systems will definitely increase. That in turn triggers your increased usage of cold chain packaging systems because most of your biologics need to be temperature controlled. So, there will be a lot of emphasis on cold chain packaging, which, in my personal opinion, is a little bit – it's a little underrated. But I think there will be a lot of emphasis on that moving forward. There has been a push to replace plastic blisters, right, targeting more towards PVC or any kind of plastic. So, the search will continue. I don't think we have a good replacement today. The other interesting thing that I have noticed, Caroline, is companies are hiring big profile consultancy firms to help with their decision making from packaging perspective, right? It can be market research, what kind of packaging systems you use in a particular market, and just getting to the bottom of it, right, trying to make the right decision so that it helps them in designing packaging or coming up with an appropriate packaging for that particular market. Like we were talking about it in the beginning, that if we are going into Europe, think more blister pack, right, if it makes sense from your company's value perspective. The other important thing I want to mention is smart softwares are gaining a lot of traction, and that will continue. There are softwares which basically design virtual tablets for you, right, and you could use those virtual tablets to design your packaging system. These softwares are time effective, that you can have drawings in minutes, in seconds, right? If you plug in your requirement specification, you will get a 3D model of your tablet, and that can get translated into a packaging as well. From if you're doing a bottle size assessment, or if you're doing any kind of packaging assessment, these models would definitely help you. There is also a huge development in virtual simulation arena. Basically, you can design your packaging process and virtually see how it works. You can look into finding risks, flaws, your cycle time. So there's a lot of advancement in the 3D virtual space. Fantastic. I mean, lots of technology there that you've mentioned, Manu. So looking further ahead, I mean, what kind of innovations do you anticipate in the next five to 10 years? There is a bunch of innovations that I have seen, I've read through the edges, right? There is a lot happening in this field, Caroline, right? So let's focus a little bit on the desiccant itself, right? So desiccant is a very important part in the pharmaceutical packaging realm for oral solid dose. Currently, we use a traditional plastic canister desiccant. That is not sustainable, right? Again, emphasis on sustainability, what are the innovations to support that? So there are desiccated blisters, which basically you can control the moisture in each pockets of blister, right? You can heat stake this patented material to the blisters and that controls your moisture environment for your tablets. There are desiccants which are embedded in the bottle itself, so you can basically eliminate your plastic canister that you basically put it in your bottles. That actually in turn helps the carbon footprint, you're reducing a component. So that's a fantastic innovation in my opinion. There is also the vial and bottle sleeves which can be inserted and custom made in bottles. Instead of embedding a desiccant, you would have a layer inside the bottle where it would protect from moisture and again eliminate the need of a physical plastic canister desiccant. There is also another sustainable desiccant which is biodegradable desiccant that is used primarily mostly in the oral solid dose space, which is again gaining a lot of traction. You can replace the plastic desiccant with this sustainable desiccant. There has also been some effort to replace the glass vials where feasible. There has been a material called Crystal Zenith plastic which basically mimics the glass vials, right? So I have seen the trend that's upcoming. A lot of flexible vendors have developed different blister solutions where you go from three ply to two ply, reducing 40% of the material itself, but still have the same characteristics which is used in blister packs, which supports both child resistance and senior-friendly packaging, which helps it pop out. It doesn't compromise the functionality itself. There's a lot of advancement in the material space. Auto injectors are one of the most effective packaging systems out there for injectables, but it's super expensive, right? I think there has been a lot of efforts made to reduce the cost of auto injectors. So in the future, I see a lot of advancement in auto injector space as well. We do have pre-filled syringe, the next best thing compared to auto injectors today in the market, but the functionality, the ease of use of auto injectors is unmatched. So there will be a lot of development in that particular aspect. There is a lot of emphasis on the patient adherence as well, right? There are a lot of caps that are used today in the market. These caps basically screw on top of your normal bottle. These are primarily used for clinical study. These caps basically remind you, keep caps of when the patient takes the medication. It sends automatic alerts to the doctor and even the patients, they can download these apps on their phone and set reminders, which talk to your bottles. And when the cap is open, right, there are different kinds of mechanisms. There is a smart blister pack where when you open the blister, there is an electronic RFID embedded in it, which basically tells you when the pack was open. That means that is that particular time the patient would have taken the medication, right? So all these signals are sent via phone to the healthcare professionals and to the patient to stick with the medication adherence. And there is a lot of things like TalkPaks, which basically talk to you, remind you to take the medication on time. As we wrap up, I just wondered if you've got any final words, you know, what excites you most about the future of packaging? Yeah, absolutely. I think, like I touched, there is so much innovation going on. I'm very excited about how it all comes together. Again, in the automation space, like the blockchain, cell and gene therapy space, I think we can feed off all this innovation and kind of work towards one goal. With the global warming, I think packaging can play a huge part from sustainability perspective and support that. There's been a lot of innovations from material perspective. So I think we are heading in the right direction here. But there's a lot of innovation and a lot of things to happen. Unfortunately, that's all we've got time to discuss today. But thank you so much Manu for sharing those details on the packaging development and looking ahead to some of the exciting technological evolutions that we might see in future. On behalf of European Pharmaceutical Review, thank you all for listening and we hope you'll join us for our next episode.
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