As drug development teams finalize molecule optimization, packaging development begins. Often, it's time-consuming process of evaluating multiple components, suppliers, and test results. For prefilled syringes regulated as combination products, ambiguous requirements, and extensive verification can add months to clinical timelines with no guarantee of full risk coverage. Today's session introduces a new approach to prefillable syringe systems, a fully harmonized solution integrating the syringe barrel, plunger, and a needle shield tip or cap from a single verified supplier, West Pharmaceutical Services. We will be led by Dr. Bettina Boltres, Director of Scientific Affairs, Integrated Systems with West. She will share how this integrated system reduces complexity, minimizes testing burden, and enables emerging biotechnology companies to accelerate readiness for clinical fill while conserving time and resources. I'm your host, James Crossland, with Pharmaceutical Online. I'd like to thank you, the audience, for attending today's event. This is live, so we do encourage your participation. Take a moment to get comfortable with the tools on your screen. Bettina's contact information is to your right, and below me, you'll see a question box. Please share your thoughts with us during the presentation. We will answer as many questions as possible, and any we miss, I'll pass along for follow-up after the event. This question box can connect you with me if you run into any trouble, but please try refreshing your browser first, as it will fix most common issues. Finally, today's event will be available on demand. You'll receive an email with a shareable link shortly after we conclude. Now, without further ado, let's begin today's presentation. Welcome, Bettina. Thank you very much, James, for the nice introduction. And good morning, afternoon, and evening, everyone. Also from my side, a big thank you very much for joining our webinar today. As a leader in the containment and delivery space for injectable medicines, having very close relationships with all our global customers, we've been involved in countless exchanges with them and also with the rest of the industry. And I have to say that we, as pharma industry, are already doing a really great job bringing medicine to the patient and continuing to develop and improve. However, in the course of all these discussions over the past decades, it became very clear that the challenges and pressures have become harder and more cumbersome, and it became a real struggle to design a PFS system out of components. We all know it takes around 10years-15 years with an investment of around $1 billion-$2 billion to bring a medicinal product to the market. Everyone is trying to secure patents, so the faster you get to the patent filing, the more time you have to still earn from it. But typically, with the lengthy development and regulatory timelines, effective market exclusivity is often reduced to only seven to 12 years. So since 2016, the time from first patent to launch has shortened from 16 years to an average of 10.6 years, for especially for larger pharma companies, and that is a difference of five years. A A single day of delay can already result in losses of around $500,000 in sales, especially in high-value therapeutic areas. While the average daily revenues per product have declined by around $80,000-$100,000 in recent years. The constant drive to reduce supply chain complexity, especially since COVID time, just adds to the global pressures to keep medicines affordable and accessible. Between the cost and complexity of development, the long regulatory timelines, constrained patent protection, and today's global pressures to keep medicines affordable and accessible, efficiencies in development and rapid market access are critical for pharmaceutical companies. That's why I would be very curious to know from, especially the pharmaceutical companies here in the webinar, which of the three mentioned pressures is the heaviest for your company? Is it increasingly complex global regulations? Is it more time and resources needed for device development? Is it increasingly complex supply chain, or is it all three to a similar extent? So you should see a window that is opening up individually from the webinar now, and I'm asking obviously, specifically the pharma companies online, as you are faced with these pressures and challenges, what is your opinion? Increasingly complex global regulations, resources needed for development or the supply chain, or all of those to a similar extent? I'll give you five more seconds. And then let's take a look at that. So 50% of you say all three to a similar extent. Yeah. But then we see device development. If you chose one, then the time and resources needed for device development is outpacing the regulations and supply chain. So yeah, thank you very much for that. So we see that actually this is real, this is real pressures and challenges out there. So being regulated as Combination Product has added an immense complexity to the entire development and regulatory process. Historically, syringes have more been treated like container closure systems, like the immediate packaging, and thus as part of the drug. So it was sufficient to just fulfill the pharmacopeia requirements. Now, based on the fact that syringes are not only holding the drug, but they're also used to deliver the drug, the classification has shifted towards being evaluated as a device as well. And so this means the empty syringe and the device constituent part, have to now also fulfill device regulations. And adding to that, if you want to launch globally, you have to deal with multiple regulatory agencies, and I don't think I have to elaborate more on that. And especially in Europe, with the stronger integration of the Notified Bodies, this has become particularly complex. So this requires companies to constantly add personnel and budget. As mentioned, being a combination product now, also has to be considered in the development process. This means that they not only have to fulfill pharmacopeia requirements, such as USP 381 for elastomer components or 660 for glass container, but also device component requirements that are given in ISO standards, such as the 8871 series for elastomer components or 11040-4 for the glass syringe. Another obvious trend that has crystallized over the past years is the shift towards thinking as final systems and not only as components that are being bundled together. This can be seen in the increased development of chapters and standards that evaluate the final finished product, such as in USP 382, 1207, and 11040-8. Another very obvious area is the biocompatibility with USP 87, only for elastomer components, whereas ISO 10993 is for the entire final product and with completely different requirements and approach. So in an effort to try to be in control of all of these requirements, companies are again adding personnel, resources, and budget to the development teams. And there's the continuous risk of missing information that is only realized during the submission review by regulatory agencies. And going even one step deeper, development teams have to create the system from individual components coming from individual suppliers. And just to give you some examples of the complexity, right? The current approach is for development teams to scout the market and get in touch with multiple suppliers, like Supplier A for the rigid needle shield, Supplier B for the glass syringe, and Supplier C for the plunger. Then they request samples from all of them. They test all possible combinations to find a good match, and then before they even do their design verification, they need to develop their system specification from all the component specifications. For example, if we look at particles, that is given as percentage of USP 788 for the glass barrel. And it's given as X per number per size range per 10 cm2 for the plunger, which is not including the silicone oil. Looking at silicone oil as is, given as milligram per barrel for the syringe barrel, but milligram per square centimeter for the plunger. Break loose and glide force is kind of tested for the glass barrel, but which plunger are they actually using? They're using whatever plunger they have available, which is most likely not the plunger that you are going to use in your final product. So you have to repeat the test. It's informative. It's nice and interesting, but it's not super relevant for you. And for the plunger, for example, it's not tested for release. There is characterization studies, again, with certain chosen syringe barrels out there. Endotoxins are given as endotoxin unit per square centimeter, per milliliter or per piece. So it's all over the place. And then obviously, once you're approaching regulatory submission, you need information that you put into your eCTD. So you're heading out, talking to all of these component suppliers, collecting information that you receive in various PDFs, individual PDFs, that you then have to put together into one coherent document. And then I was talking about samples, requesting samples. If you were to order samples with individual suppliers, they would come at different lead times, and they would come with their own specific minimum order quantities, which are typically not matching the ones that you actually need. And so I would be very interested again to know from you all pharmaceutical companies online, do you know this struggle from your development? Yes or no? Do you encounter this? Is this an issue, or is this a challenge that you're faced with as well in your development? Or do you say, "No, actually, in our development, everything runs super smoothly, we have everything under control," versus reaching out, translating all the different numbers and data into one is kind of cumbersome. So there's a new window again, that opened up. Gonna give you a few more seconds. This should be a straightforward question to answer. So the poll is still open, but let's look what the results now say. Okay. An overwhelming 92% say that they know the struggle from development. But to be honest, I would love to get in touch with the 8.1% saying they don't see this from their development, because obviously they know a secret that the 92% online don't know. So I would be very curious to learn about that. Wonderful. So thank you very much for your answers. So apparently, we see that somehow this process is working, but as we see, as we've seen, just with a really large investment in resources, personnel, and budget. Often with the involvement of consultants or external lab organizations, you're forced to navigate, coordinate, and interlace multiple component data sets and services to create your system-level performance data for your PFS selection. Or you could choose manufacturers that offer expensive and, and time-consuming one-time data packages through customized services. So you work with your various component suppliers for each individual component in an attempt to compile and reformat what you believe is needed for a regulatory submission. And you manage multiple component suppliers with restrictive minimum order quantity options and varying quality levels. Although well-intended, these approaches unfortunately have consequences, all of which can delay product launch and increase risk and cost. This can include missing a critical element of performance testing, forcing you in the end to go back and repeat that testing, a delay in the regulatory approval process, and an inability to deliver the quality and quantity of pre-filled syringes needed to achieve your milestone. While it's obviously still possible to make progress, these risks can cause you to miss critical milestones and/or run out of time and resources. The reason for this is that many emerging companies believe they must assume the time, risk, and expense of coordinating multiple PFS components, and may make the wrong assumptions. But your primary objective actually is to achieve critical milestones in your development process. So I can proudly announce now that West has come up with a solution to mitigate these challenges, and help you reach your goals faster and smoother now. With our integrated, verified, prefillable syringe system. Specifically, this means that you will save time and money using a single, integrated, already design-verified, prefillable syringe system, consisting of a glass syringe barrel, fixed needle or Luer lock, and the matching plunger. You will save time and money streamlining your regulatory submission by using one accountable source for all required data, and you will save time and money establishing a reliable supply chain with the quality and quantity you need from one single source. Starting with West Synchrony S1 PFS system means starting with an integrated, verified PFS system that enables you to overcome those exact three challenges: designing a syringe system out of components, navigating a complex regulatory process, and avoiding supply chain setbacks. With the Synchrony S1 PFS system, West has redefined what a system is. Our prefillable syringe system is an integrated offering that was designed and is released and delivered as a system. As we, West, have designed the entire system from scratch, we, West, own the entire development process, so you don't have to communicate with multiple suppliers anymore. We've also performed the entire design verification process to prove the system, and we are sharing this, so you don't have to purchase it and wait for the results. And as appropriate for a real system, we are testing it as a system upon release, so that you don't have to struggle with multiple incoming inspection tests anymore. And because it all comes out of one hand, we're shipping everything in aligned quantities on the same pallet. Looking further into how we aim to save you time and budget in your development process, we streamlined all the information sharing into four major packages. The Scouting Info Package gives you all the information you initially need to assess the system. With the Onboarding Package, we ensure a smooth and streamlined onboarding of both you and West into our SAP systems. The Verification Data Package gives you all the necessary data from our DV testing to ensure you have a solid scientific justification for your choice. Finally, once you approach submission, you get our Regulatory Package, where you can copy-paste all content directly into your eCTD file. All these packages are for free and immediately available as per your milestone in your journey. To support your confidence in the system and to save time and decrease complexity in your incoming inspection and surveillance process, we have developed one system-level specification, meaning for each of the attributes, you will get one data point for the entire system. One particle specification, one silicone oil specification, one endotoxin spec, and one break loose and glide specification for the entire system. All of these will be given on one quality certificate. West has made the entire customer journey transparent, simplified, and streamlined. Apart from the system-level data that you will get for each and every batch, you will still also get all the component-related data on one quality certificate, and I mean all the measurement data of the glass syringe, the closure, needle shield or tip cap, and the plungers on one quality certificate. I wonder where you get that level of detail and compactness right now. As we, West, own the entire system, it has one item number only, one item number only, and it comes with matching minimum order quantities on the same pallet at the same time. Our intention was to accompany you throughout your journey and support you with exactly what you need at every step. When you start your search with scouting the market and searching for the best components, we give you the Scouting Info Package with all the information you initially need to assess the system. After careful evaluation, you optimally decide to go with us, and we onboard you in an efficient and smooth way. Then we have the exact right quantities for you, the Flex quantities, to order to perform your drug-dependent testing to prove the system with your drug. You don't need to do any of the drug-independent testing anymore, as we have done everything for you, and you get all the data within the Verification Data Package. For any commercial fills or potential engineering runs, you will order the standard quantities, and once you are approaching the time to file your regulatory submission, you will receive the Regulatory Package from us, containing all the information you need, that you can copy and paste all content directly into your eCTD file. Because we own the entire system, we put it all together under one DMF. So you just need to request one LOA from one company. And even after you receive your marketing approval, if you see complaints from the market or have any other topics, you need to just coordinate everything with one company. So no cumbersome three-way CDAs, no passing the buck because no one wants to take on the responsibility. It's our system, so we have to fix it. Again, our main goal is to streamline your pathway to commercialization as much as possible. So let's take a look at our data packages throughout your journey again. The Scouting Data Package is a technical overview with key product highlights. Within its 67 pages, it contains the system overview, the master specification, including system-level specifications, chemical and physical data of all the components, compatibility overview with needle safety device and auto-injector, and fill finish equipment, quality and regulatory information, packaging, shelf life, and the different quantities per pallet, drawings, and a list of item numbers, and more stuff. So really everything you need for your initial evaluation. Then the Onboarding Package contains all the information both you and we need to get set up in our system quickly. For example, how to place a PO, receiving and shipping information, our SAP item decoder, information for quality agreements and audits, the quality certificate, and much more. Then you will love the Verification Data Package, because within its over 80 pages, it contains our entire DV approach, explaining how we choose the sample sizes we choose, or why we choose the sample sizes we chose, the bracketing approach, and it gives all the results of all of our DV tests. For example, needle shield pull-off force, needle pull-out force, needle penetration, flange breakage resistance, break loose and gliding force, needle pull-out, as I mentioned already, different CCI tests, deliverable and residual volume, but also characterization work, such as biocompatibility and extractables. And to save the toughest part for last, our Regulatory Package aims to support your submission, especially in non-DMF regions such as Europe, where you have the MDR and its GSPRs. In that package of 80 pages, you will find all the information needed that you can copy-paste directly in your eCTD file. Again, all of these documents are for free and readily available as per your milestone, and all of these documents are controlled documents, so they undergo our official change process. They're all peer-reviewed, they're all revision-controlled, so it's a single source of truth that is always up to date. Because we wanted to make this a drop-in solution, we have designed the West Synchrony S1 PFS system to fit into the pharmaceutical ecosystem. We are already working with a global CMO network that have the system pre-qualified on their lines, ready to go. You can even save the engineering runs. We truly mean global. We're working with CMOs in every region, in Asia and Europe and in the U.S. So no need for you to spend time on searching for a CMO, ordering the individual components, waiting for them to arrive at different time points, coordinating with all suppliers. Nope. The CMO is already set up. The syringe system is coming at the same time on one pallet, ready to go. Then, obviously, all of our components are compliant with all regulatory requirements. We're using SCHOTT Fiolax glass, which everyone knows is Type I compliant with USP 660, EP, and JP. And all our syringe barrel dimensions are according to ISO 11040-4. So there is no changes, no difficulties there. And, lastly, we've run our systems on all relevant fill-finish lines, again, saving a considerable amount of time. I'll get to that in a minute. We've also tested our syringes, syringe systems with leading needle safety devices and leading auto injector suppliers. So as mentioned, we have worked together with the two leading auto injector suppliers, and we have verified that our Synchrony S1 PFS system works with both their 1 mL auto injectors. We have tested cap removal force, injection time, dose accuracy, dimensions, and break loose and glide force. That was with filled syringes, with water for injection, and further tests are planned down the road. Then we've worked together with the four leading fill-finish line manufacturers to ensure that our Synchrony S1 PFS system can run smoothly on their lines. We've tested de-bagging and de-lidding of the syringe barrel assemblies, the handling during IPC, the sorting efficiency in the feeder bowl and the sorting tracks, and the compatibility with both vent tube and vacuum placement. All manufacturers are very well aware of our offering and have the respective parts there. In case you want to run the system on your existing lines, I would suggest, obviously, you reach out to your line manufacturers, as, as I said, they're very well aware of our offering and can help you out quickly. And again, should you want to work together with a CDMO that have our system already pre-qualified, you don't even need to go through any of this yourself. Now, the very important question. We have more than 200 validated systems for biologics and vaccines applications, ranging from 1 mL long staked needle, 2.25 mL staked needle, 1 mL standard staked needle, 1 mL long Luer lock, 1 mL standard Luer lock, and 2.25 mL Luer lock. So the entire variety of choices. We have different needle gauges and wall thicknesses, 27-gauge thin wall, 29-gauge thin wall, which is kind of a standard in the industry. Then we also have for the 2.25 mL staked needle, the 27-gauge special thin wall. We have rigid needle shields, soft needle shields, and integrated tip cap available. In terms of flanges, we have small round flange, large round flange, and cut flange. And as for the plungers, we offer, obviously, our NovaPure plungers, which are the standard for biologics, but then also our FluroTec plungers and the unlaminated plungers as well. To make it really clear to you what we mean by one system, let's take a look at the supply chain. So you can see in the center of the slide that our manufacturing plant is the plant in Waterford, Ireland. The needle shields or tip caps are assembled by our glass syringe manufacturer, and both the plungers and the syringe barrel assemblies are stored in our warehouse in Ireland. This is especially true for our make-to-stock items. I'll get to that in a minute. Once you order a system, a representative amount of the parts, the syringe barrel assembly, and the plungers, are sent to our lab in Waterford, where they are assembled on a small filling line and then tested against our system specification, right? You remember, endotoxins, particles, silicone oil, and break loose and glide force. Only if they pass the system specification release testing, will we send them over to you on one pallet at the same time with matching quantities. We will print the results on the quality certificate, so you will get all the results of the individual parts and the system data on one single quality cert. As mentioned, we have more than 200 validated systems for biologics and vaccines applications that were all designed with a holistic product and quality mindset to find whatever is best suited for your application. To make the platforming approach even easier, we have created two Signature systems that we have in a make to stock option, right? So make to stock means that we have those, the components that make up the system on stock in Ireland, waiting for you to pick up the phone and order them. So we only need to test them against our release specification, and then off they can go directly into your manufacturing plant. The two Signature system options are: the 1 mL staked needle with rigid needle shield and 27-gauge or 29-gauge thin wall needle, 0.5-inch, with a small round flange. For the plungers, you can decide between the NovaPure plunger and the FluroTec plunger. The barrels come in 10 by 16 configurations, and the minimum order quantity for Flex quantity is 12,000 systems per pallet or per order, and the standard quantity is 48,000 systems per order. The other Signature system is the 2.25 mL staked needle, that also comes with a rigid needle shield with 27-gauge thin wall, small round flange, the NovaPure plunger, and the FluroTec plunger. Again, you can choose from, and it's coming in a 10 by 10 nest. Obviously, flex quantity is 7,500 systems per order, and standard quantity, 30,000 systems per order. So those are the two Signature systems, make to stock, waiting, readily available for you to call and order. All right. So by starting with an integrated, verified PFS system from West, you will accelerate the selection of a PFS system designed and verified for form, fit, and function. You will streamline your regulatory submission process, and you will establish a robust and agile supply chain for your PFS, for your pre-filled syringe with a quality and quantity you need. Now, I'm very curious, what do you all think? So now it's for everyone. Everyone can vote, not only the pharma companies. What do you all think? How cool is this offering? Do you see a benefit in this approach, yes or no? You should see again, a new window opening up. I'm super curious to hear what you think about this, and I think also, as this is quite a straightforward question, I'm gonna proceed to the next slide. Whoa! Look at this result. I love it. Thank you so much. It's like 100%. 100% of everyone who votes it, says it's a cool approach. I love it. Thank you so much. With this beautiful, wonderful, feedback of yours, I'm actually done with my presentation, and I'm super happy to take any questions that you have. And, yeah, James, over to you. Thank you so much for the excellent presentation. Before the Q&A begins, I'd like to remind our audience, you can connect directly with Bettina. Her information is located on the side of your screen. We see a lot of great questions coming in. Thank you so much for that. Please keep submitting those via the Q&A box below me. We're gonna address as many as we can, and the rest I'll pass along to Bettina and West Pharmaceuticals team to follow up offline. Our first question comes from Ashwin, asking, "Does West also offer a needle safety device that works with the PFS system? So we do not offer a needle safety device that you can buy from us. But we can provide you with a compatibility testing that we have done with the respective mentioned needle safety devices, and then you can decide for yourself. So needle safety device is not part of our offering. Yeah. Thank you, Bettina. Sure. Our next question: "Do the syringes come in a nest or tray or both? Yes. So they come in a nest and tub configuration, and as you've seen, the 1 mL long syringes, our Signature system, 1 mL long staked needle syringes, they come in a 10 by 16 nest configuration. And then the larger ones would be 10 by 10, obviously. So nest and tub configuration, and in anticipation of the next question, they are ETO sterilized. Excellent. Thank you. Yeah. Our next question is from Cecilia, asking: "Do you qualify your syringe system for leachables and extractables? Yeah. So leachables is out of our scope. As probably most of you know, leachables is something that is measured in conjunction with the drugs. So the leachables, you can only evaluate with the drug product, so we cannot do leachable testing. But what we have done, and that is part of our Verification Data Package, is extractables testing. So we've done extensive extractables testing in conjunction with biocompatibility testing, as it is, can go hand in hand, for the components. So yeah, extractable testing is available and is shared in our Verification Data Package for the entire system. Thank you very much. Our next question is from Emily, asking: "Given the extensive design verification testing already performed, what do you recommend is required in the design verification testing filled with your drug? Okay, yeah. Yeah, so, so, basically, there is two parts that the DV testing is typically done. You have the drug-independent testing, where you have, for example, the needle shield pull-off force, the needle pull-out force, then flange breakage. These are examples that are independent of the drug product. It doesn't matter what the content is, those data should not change, basically. We also have done CCI testing that is on the empty syringe system. So for example, container closure or closure system, liquid leakage we've done. We've done liquid leakage at the plunger using an Instron device, so that is also drug-independent testing, obviously. And then we've done container closure integrity at the plunger and at the tip with helium leak testing. So those would be drug independent, but then CCI testing is something that for sure you have to repeat with your drug product because there can be influences of the drug product and particularly also the handling. Then you have to see, as I mentioned, handling flange breakage. So depending on how the syringes are treated in the process, flange breakage is nothing that is drug product dependent, but process dependent. So how you treated your syringes, how many quality, how many surface defects you introduced in the process that might lower the strength of the glass, for example. And then obviously also break loose and extrusion force. So we have done the break loose and glide force. That is on empty syringes, typically to prove the silicone oil lubrication, how well that was done, how well distributed the silicone oil layer is. But then you have to test the extrusion force with your drug product individually, because if you have a higher viscosity product, for example, you might have. You will have a higher extrusion force as compared to the glide force. And the break loose and extrusion force, they belong to the so-called EDDOs that the FDA has picked out, particularly as a specific part of outcomes of design out, not outcomes, of design outputs that FDA particularly wants to see. So CCI is definitely you have to repeat that. Break loose, extrusion force are examples of that. And then, depending on your drug product, might be deliverable volume as well, but then you have to see the influence, depending. Yeah, just examples. We can discuss more, so always anyway happy to set up meetings to discuss and look into your individual case, if there's something different. Then, yeah, obviously if you go into an auto injector, you have to evaluate break loose and extrusion force differently anyway, together with your auto injector. Yeah. Excellent. Our next question is in follow-up to this presentation: "How can we get any literature?" I'd like to just remind the audience that, you will receive an on-demand version of this entire presentation to the email that you registered with, if you'd like to share it with any colleagues. But in addition to that, what, literature can the audience find? Mm-hmm. Yeah. Well, what- Specifically, the question is, what follow-up literature can the audience find, or how can they get follow-up literature for the presentation? Sure, sure. So if you go on Google and Google westpharma.com, or just put it into the browser, westpharma.com, then you will see we have a page dedicated to West Synchrony S1 PFS systems. On that page, you will already find a good bunch of information, and on that page you can click on Contact Us. So if you're not yet already connected to an account manager from West, then feel free to use the route via the homepage. And then you can, you will be connected to one of our super talented technical people and, account managers. Or you just drop an email to that email address that you see on the screen there, and I connect you with the respective people. So we do have brochures, we have info sheets. We can send you the Scouting Data Package. That's what it's meant to be for, so happy to share. Excellent. Thank you. Our next question is from Brandon, asking: Is it possible to order the components separately, or is it required to order both the syringe cap and plunger stopper? Yes. So the sole meaning, purpose, and advantage of this whole thing is that it is a system, right? So the system only works as a system. So of course, you can just go to West online store and order the NovaPure plungers as such, 'cause we're using the exact same NovaPure plungers as we're also selling separately. So you can go there and buy the components individually. No problem with that. But the system offering only works as a system. So if you buy the components individually, then you have to do all the work that we've already done for the system. You have to do all that work yourself, right? Because it's components. You don't know what you get. You get the specification, the release testing, incoming inspection. Everything is different and individual if you order it individually. So you have to invest all of the time and budget, money, resources, and brainwork into creating a system if you order components. So that is why one item number is for the entire one single system, and the system is not meant to be broken down into components. So yeah, that's it. Excellent. Thank you. Yeah. Our next question is from Pascal, asking: Are all your rubber formulations part of the platform, or only the two listed on the slide shared? Yeah. So rubber formulations, we obviously picked the best quality for all of our items that we use in, in the syringe, in the West Synchrony PFS system. So the two rubber formulations that we use in the system are the 4023/50, and the 4432/50. These are our two most modern leading rubber formulations, out of which, especially the NovaPure plunger with the 4023/50, is the one used in most of the biologics out there. So those are the two formulations we chose for the system. Thank you. Mm-hmm. Our next question: Did you consider sustainability in your development approach? So the current offering is a drop-in solution to the current market. So that's what we wanted to bring out there, and that's what we wanted to start off with. But in the background, as you can imagine, we're already working on further developments, which will definitely include all possible sustainability aspects. So we're already scouting, we're already looking into all possible options, how to include sustainability into our design of the next developments. Yes. All right, our next question: Did you do CCI testing as part of the DB, and is that given in the DB package? Yes. Yeah. So we did do CCI. I think I mentioned a little bit. Probably the question came in before I mentioned before I mentioned already. So we did do closure system, liquid leakage. We did do liquid leakage at the plunger, which is both using Instron devices, and then we did CCI at the plunger and CCI at the tip using helium leak. And all of these four tests are described in the verification data and given. So, yes. All right. Yeah. Gonna now go to the next question: What happens if you have a recall or other quality issue with one of the components? Yes. So the typical way how you would handle it right now is... Let's, let's just say you have something on the market, a drug on the market, and the market comes, comes back with break loose glide issues, right? It's too hard to push, the glide force is too high or the break loose force is too high. Now, the reason for that could be multiple, right? And unfortunately, with this case, like with several other cases as well, like particles, for example, multiple component suppliers would potentially be involved, because one of the reasons or one of the parameters influencing the LG force is silicone oil, right? And you have silicone oil on the syringe, and you have at least the FluroTec lamination film and B2 coating, but some kind of lubrication on the plunger as well. So it could be both, or it could be your process. So what typically happens is, you try, you as pharma company, try to discuss with the glass barrel supplier, with the plunger supplier, and everyone's like: "Oh, no, that's not my fault, it's their fault. You're within spec. We don't know what it is." So everyone's passing the buck, and you're kind of stuck in the middle, and no one feels responsible. With the West Synchrony S1 PFS system, you have one source that you get your system from, so there is no one that we can pass the buck to, right? We cannot not take responsibility. It's our system, so we have to fix this. And that is for you, this is a huge advantage. You just call your account manager and say, "I have an issue, fix it." And so we have to fiddle in the background. We have to try to find out where the problem came from. But you just have to pick up the phone and call one person. No three-way CDAs, no passing responsibility or anything. So that's really, we see one very, very big advantage of the system approach. Yes. Great. Our next question is from Brandon, asking: Do the components have independent shelf lives, or is it one shelf life for the whole system? Yeah. So because it's a system offering, there is a system shelf life, and the system shelf life is, as of now, two years, because that's the shelf life of the component with the shortest shelf life, so to speak. So they do technically have different shelf lives, which is why we decided to go with the one that is shortest, and that is two-year shelf life for the entire system then. Yeah. Great. Our next question: Does the particle specification include subvisible particles? Yes. So the particle specification depends on the plungers that you are choosing. So as some of you might know, we have the NovaPure, which is our highest quality offering, and then we have the FluroTec plungers, which come in a Westar Select quality level. So both of these plungers come with subvisible particle specifications, but the NovaPure plunger, because it's our highest quality offering, has a lower particle specification as compared to the FluroTec Westar Select, which is also already low, but the NovaPure is just the lowest. And we specify particles from 10 µm and 25 µm. So, yes. All right, our next question: Did you test the auto injectors with different viscosities as well? Yes. So the ones that, I just mentioned on the screen quickly, that was with water for injection, so that was just 1.0 centipoise of viscosity. But then we've also tested with 15 centipoise of viscosity. Everything worked out well, and we're actually planning further testing with, different parameters also, and also the 2.25 mL as well. So, yes. Excellent. Our next question is from Taiwan, asking: How do you reconcile different risk profiles of different products with your design verification? Different risk profiles of? Different products with your design verification. Different... Say it again. With different risk profiles of? The beginning. How do you reconcile different risk profiles of different products within your design verification? Products. Risk profiles of different products. I'm not a hundred percent sure I understand that question. So let me just answer how I understand it. So for the design verification approach, you obviously need to do a risk assessment, right? We did an FMEA, and within that FMEA approach, you have to assign risk scores. And obviously, as a supplier, because we don't know the actual application in the end, we cannot assign a risk score based on the actual usage and intended use application in the end. So we assign the risk scores based on our knowledge of the drug-independent part, so to speak. Mm. So the risk scores might not align. They might align, but they might also not align with what you individually have in your company. Also, anyway, every company decides that differently. So I think if we compare FMEAs from 20 different pharma companies, we get 25 different results on several of the aspects, I assume. So this is probably a topic that we can very nicely discuss in a technical meeting where we go through the Verification Data Package and take a look at how we categorize the different tech parameters. Hopefully, that kind of answered the question. If not, drop me an email, and we can discuss. Absolutely. Thank you for taking a shot at answering it. Mm-hmm. All right, our next question, let's see: Are the system-level specifications based on pharmacopeial requirements? So yeah, so we had to adjust the methods a little bit to accommodate our system approach, right? Using the fluid path, because it's a system, and we're using the fluid path, we had to adjust the methods a bit. So the particles method is following USP 788, where we're using a particle counter. The silicone oil from the entire system fluid path, again, is dissolved and then measured using AAS, which we had to develop. And then endotoxins is per nominal volume of syringe system, where, again, also we dissolve the endotoxin from the fluid path in a clean solution, and then we measure them using a Charles River reader. I think that's standard. Everyone's doing that. And break loose glide force is just straightforward using an Instron device. So, yeah. Perfect. Thank you. We have time for two more questions. Mm-hmm. Have there been any discussions on PFAS and long-term replacements, assuming the coating is fluoropolymer? Yeah. A very obvious question. So yes, of course. So of course, the PFAS discussion is all over the place. Everyone is looking into it, so I don't think there's a single company in this world that is not looking at it. So we're obviously also looking at it. And, also, just like with the sustainability, this offering we currently put out in the market to set as a drop-in solution to the current market. But in the background, with our new developments, we're obviously also working on solutions answering the PFAS discussion out there. So coming up. Yeah. All right. Final question from Ken Roy: Does your package include transportation and shipping validation data? Yes. Yes, it does. So the Verification Data Package does include transportation and shipping validation data, and, or the, the transportation and shipping data, reports, summaries, and, we've also done that prior to our DV test. So yes, it contains, and we can... Happy to, to go through that. All right. That was a quick one, so I think we can sneak one more in. Yeah. This one from Chen Zhu. If we use the West system with a two-year shelf life, then is the drug product shelf life limited to two years as well? So the drug product shelf life is not related to our system's shelf life. So the system shelf life means that the product is sterile for two years if you keep it in your warehouse, cool, not too much heat and, and humidity, just sitting around for two years. Then after one year and 364 days, you can still, you, you could use it, it's still sterile, so that is basically the claim. There is nothing really happening to the rubber, so it's not, neither the rubber nor the glass breaks down after two years, and you cannot use them anymore, but it's more the sterile claim. So whenever you open your package, the, the syringe barrels and the plungers, and feed them into your filling line, then actually your calculation starts new. Because you put your drug product on stability studies, which you have to do, you cannot... Right? You have to do that for submission. For regulatory submission, you have to give stability studies. And in the course of these stability studies, you're proving that both the glass syringe and the plunger are performing the way they should according to their intended use. And so you're extending your shelf life based on your stability studies. So it's two separate things. That's excellent. All right, everyone, that is all the time that we have left for today. Don't worry if we didn't get to your question. I'm going to pass them along to our presenters and the West Pharmaceutical team to follow up offline. I'd like to thank Bettina and West Pharmaceuticals for providing their expertise today, and you, the audience. We appreciate you being with us and hope to see you again soon. Have a wonderful rest of your day. Thank you very much. Bye-bye. Thank you. All right.