The Need for Collaboration to Ensure Excipient Availability and Innovation
In this deep-dive panel discussion moderated by The Pharma Navigator, several experts map out the future of excipients, addressing everything from climate-driven disruption to the need for greater industry collaboration.
During CPHI Frankfurt 2025 (1) and more recently in a virtual setting, a panel of experts convened to discuss the important topic of sustained availability of excipients and patient impact, touching upon key considerations, including: the definition of excipients; the current shape of the global market; the impact of novel therapeutic modalities on excipients; potential legislative restrictions; the challenge of misinformation; the actions needed to mitigate falsification; the need for supply chain transparency; sustainability considerations; and the issue of onshoring/reshoring. The panel also revealed their potential future expectations for excipients.
The panel comprised: Iain Moore, Senior Advisor Operations for EXCiPACT; Nigel Langley, Global Technical Director, Life Sciences, gChem; Robert Williams, Senior Director, Sustainable Procurement at AstraZeneca; and Bram Baert, Head of Global Regulatory Affairs at Lonza Capsules and Health Ingredients (CHI); and it was moderated by The Pharma Navigator’s Associate Director of Editorial and Content, Felicity Thomas.
Click above to view the full virtual video panel discussion, read on for the transcript, or click here to view the live version of the discussion hosted on CPHI Online…
Defining Excipients
Thomas (TPN): First of all, can you provide us with the definition of excipients and also a perspective on the current shape of the global market?
Moore (EXCiPACT): In Europe, excipients are legally defined as everything else in the drug product that's not the active ingredient; but actually, I prefer the IPEC definition, which is along the same lines, but includes the requirement that they are intentionally added as well. It's important to realize excipients are administered to the patient by intent, and, so, they must be manufactured in accordance with GMP [good manufacturing practice] principles.
Then, we need to recognize that they are included in the drug product because they have a role to play in the therapy and the delivery of the therapy. That role can range from very simple — there's a bulking agent in a tablet that delivers a 10 mg dose to the patient — right through to the lipid nanoparticles that encapsulate them — messenger RNA in vaccine and related therapies. It's really, really important, though, not to confuse the role of the delivery of the therapy with activity. Excipients are, by definition, inert when it comes to therapeutic effect.
In terms of the global market and geopolitical pressures, onshoring and so on, are putting strain on the approval of new excipient suppliers. The question everybody has, drug products, regulators, too, in many countries is: How do I identify a good, reliable, committed supplier of excipients? The first step in answering that question is to get evidence they've applied GMP. The use of GMP Global Certification Schemes like EXCiPACT has greatly facilitated the approval of new excipient suppliers, to the acceptance of industry, and increasingly the regulators as well.
Impact of Novel Therapies
Thomas (TPN): Novel therapies are becoming more and more prevalent in the development pipeline. So, how is that impacting excipients? Are they being left behind in terms of innovation?
Langley (gChem): That's a very interesting question, and I think it's very true. What I see, and I think the industry shares this same sentiment, is that formulators are still using products that can be 50, 60, 70 years old in so far as that's when they were first introduced into pharmaceutical applications. Well, that's the excipient side, the modalities, as you mentioned, have really progressed rapidly, especially in the biologics area, and I personally feel that the excipient innovation has been quite stagnant, and there's reasons for it, and I’ll try to explain some of those reasons in just a minute. But, for sure, I feel that the excipient side has been left behind a little bit.
The reality is that probably over 90% of excipients, if not more, have not been designed for the purpose that they are being used for in formulation — they're not fit for purpose, as we describe them to be — and, as a result of that, they have to, in some cases, be stressed, or micronized, or modified into a different type of physical form in order to actually carry out the function that's desired in a particular formulation. Clearly, that's not desirable, and I think we've come to a point now where that's kind of even more challenging, and the attrition in the pharmaceutical area will further increase, I believe, because some of these interesting drug candidates are just not suitable to formulate with the excipients that are currently around.
Now, how can we do something about that? We had some really positive news a few years ago, and IPEC was very much involved in this story, as well as the IQ Consortium and the USP, to actually get to a point where the FDA recognized the need for novel excipient innovation. And, also, to have a mechanism whereby, hopefully, the regulatory hurdles or the barriers would be lowered a little bit in order for that innovation to happen.
As a result, the FDA, introduced a pilot review program for a novel excipient evaluation called PRIME — a two-year program that actually ran for three years in the end. We're not sure, actually, and there hasn’t been a definitive response from the FDA, whether this program will continue. So, we're not sure whether the program will continue, but, we suspect it won't, which is a real pity. We will try to revisit early next year and see whether we can reintroduce and have the dialogue with the FDA, because the situation still remains. Taking messenger RNA in vaccines as an example, well, they contain novel excipients. There were two major vaccines, and they had a novel excipient in each of them. It would be a very sad case, in my opinion, that we would need to have another pandemic before a next novel excipient is actually adopted and used in a pharmaceutical drug product.
We've gone back a little bit in time, I think. I sense that the innovation incentive now for excipient suppliers has basically reverted to what it was before the pandemic. Unless we work collaboratively in the industry, I think it's going to be very challenging to develop novel excipients in the future and introduce them because of the level of investment required and the low return on investment for suppliers themselves. If it takes 10 to 20 years with uncertainty that you'll get a return on the capital investment that has been put into the work, then it's not a trivial thing.
So, to advance the excipient innovation, I personally believe that pharma companies and excipient suppliers need to talk to each other more closely and really identify where the market needs are and then work together in some way to actually develop and incentivize that process.
Restrictive Legislation?
Thomas (TPN): As mentioned, there has been some recognition of the need for innovation in excipients; but are legislations too restrictive to allow for innovation?
Baert (Lonza CHI): Whether or not regulations are too restrictive is subject to interpretation, but for sure regulations are posing restrictions, and, in fact, in various ways. Nigel already touched upon such restrictions in the context of novel excipients. In many regions, there is indeed a lack of regulations that allow for an independent excipient approval, which means that excipient manufacturers are, in fact, largely dependent on excipient users to advocate for new excipients to be used in their direct products. This situation creates uncertainty for the drug product manufacturers on obtaining approval for their marketing authorizations — drug product manufacturers are not always willing to take such risks — and so this really demonstrates how the current regulatory framework is restricting innovation in the excipient world.
Another regulatory area where I see restrictions are diverging regional requirements for excipients, especially in terms of specifications — such differences in specifications may make it impossible to meet all of the required specifications. As a result, companies have to create regional stock-keeping units, which adds complexity to the supply chain, and sometimes even restricts the availability of certain materials for certain markets.
And then, there's, of course, also these direct bans. This is typically about new or updated regulation that is prohibiting the use of certain excipients that have been used for a long time because of potential safety concerns. Of course, it is good that substances that have already been on the market for a long time are now being reassessed by competent authorities according to contemporary safety standards. But the regulatory decision-making process is sometimes confounded, and titanium dioxide is a nice example: It is being banned in the European Union for use as a food colorant, because the European Commission was no longer able to confirm its safety based on current scientific data. However, many other authorities, including the U.S. FDA, Health Canada, Australia, Brazil, Japan, and many others came to a different conclusion.
Red dye no.3 is another example. So, the FDA banned the use of Red 3 as a colorant in both food and pharmaceutical applications from 2027 or 2028, respectively, but although the FDA confirmed in their re-evaluation that they see no safety concerns with the use of Red 3 as a colorant, they in fact had to ban it because of an old clause in U.S. law that does not allow for a risk-based approach, and that may, therefore, pose unjustified restriction.
Of course, it goes without saying that substances that truly pose a safety concern should be banned. But unilateral bans that are not supported by solid, sound scientific evidence, pose an unnecessary burden for the pharmaceutical industry — products have to be reformulated, and this may ultimately even lead to patients not receiving their drug products.
Issue of Misinformation
Thomas (TPN): Solid, sound, scientific evidence is obviously pretty key; however, industry is being impacted by the issue of misinformation more and more. So, what can be done to mitigate misinformation around excipients and what actions should stakeholders in the industry be taking?
Baert (Lonza CHI): It’s clear that the pharmaceutical industry cannot simply fight this misinformation by posting facts demonstrating opposite messaging, so, it's all about transparent communication, providing an understandable version of the scientific facts, as well as providing the full context with not only focusing on positive elements, but also acknowledging risks and uncertainties. However, this is only the base.
In addition, the trust of the public should be gained by, for example, working together with healthcare practitioners or patient advocacy groups. Also, I think that the pharmaceutical industry should support educational initiatives. Of course, on social media, but also beyond. And we should also live up to ethical standards, and for example, adopt strict internal policies against misleading advertising or selective data presentation.
In short, the goal is not just to become a source of information, but to be a credible participant in the public dialogue about health.
Protective Actions
Thomas (TPN): So, let’s talk about protective actions and we need to also address falsification. We’ve seen severe consequences of falsification happening around the world, so, what actions should industry be taking to help mitigate the risks of falsification in the excipient supply chain?
Williams (AstraZeneca): It’s a great question and a growing challenge for all of us. Well, we've got information overload, almost, from the data that's now available online, and indeed available to everyone, as Bram was just talking about — of information available to the public. We've got to find that science-based information that means we can assure ourselves, and our patients and customers, of the quality and the efficacy of all the component parts of the products we produce.
So, I think it really comes down to supply chain due diligence. The practice of supply chain due diligence, of course, is enhanced through data, through AI [artificial intelligence], through web scraping, through information that's now widely available. But it's got to be properly analyzed, properly handled, properly vetted as well, and that vetting, that assurance is critical. So, the process of supply chain due diligence, of course, supported by robust and, ethically viable certification, is critical as well. Companies such as, the member companies of PSCI [Pharmaceutical Supply Chain Initiative], will rely, firstly, perhaps, on certification, on standards, and on those third-party verification certificates that we look for suppliers to provide. But that supply chain due diligence is critical. If you can't trace back from step-to-step — If you can't trace the certification and the origins of materials back step-to-step — then obviously questions are going to start to be raised.
I think the ability to undertake correct due diligence is there, but of course, there are always bad actors. And, what we need to do as an industry is really make sure that when there are challenges, that those are widely known, widely represented. to really make sure that things don't happen twice.
Supply Chain Issues
Thomas (TPN): Could you give us a rundown of the key supply chain issues for excipients, and highlight any lessons that have been learned and those that still need to be learned by industry?
Williams (AstraZeneca): The framework that we apply through the PSCI gives good guidance and doesn't apply just to excipients, but I think to all the pharmaceutical products and med tech as well. It’s really, you know, respecting some of those foundational commitments, whether that's human rights, environmental sustainability, and responsible business; but companies setting out the standards they expect of their suppliers.
So, the PSCI principles are the starting point for those 85-member companies of PSCI, but they start at governance and management systems. Those governance and management systems underpinned by another principle of ethics, good ethics, which are well represented and understood by all parties, both within the companies, but importantly, throughout the supply chain.
The ethics can present challenges, as we've just been talking about, with falsification, human rights issues is an increasing challenge that the customers of the pharmaceutical sector are really interested in. Recent audit evidence, and I think, recent representation by customers to PSCI members suggests, actually, that human rights are towards the top of the list of concerns. So, assuring that there are no human rights risks in the supply chains are critical. And of course, a safe and healthy working environment, thinking of health and safety, or SHI, or EHS, as you may present it is critical.
We've recently seen a significant number of fatalities associated with excipient manufacture in India. And, so, there's health and safety risks in that case, an MCC production site, are paramount. The environmental issues, then, around environmental discharges, that's regulated environmental discharges. I think are a final but important, principle, that we know all supply chains must maintain.
The reason I cover all of those topics is because failure of any one of those topics can disrupt supply of medicines to patients. Whether that's a human rights issue, whether it's health and safety issue, whether it's an environmental discharge challenge. And, so, there's a broad range of topics which actually is, again, as a pharma industry, we look to and ensure there's consistent standards on to support the application of those consistent standards up the supply chain to the excipient manufacturers, the raw material producers. But that supply chain transparency across all of those topics is vital to ensure the supply of medicines.
Sustainability and Environmental Considerations
Thomas (TPN): Focusing on sustainability, what kind of impact might we expect on excipients as a result of greater sustainability requirements from industry stakeholders?
Baert (Lonza CHI): Indeed, sustainability is very important, and it's only going to become more important. We will certainly see an impact on packaging practices, so the European packaging and waste regulation has already been published and is gradually being implemented as from next year.
But we also expect a shift towards more sustainable sourcing practices, a higher transparency on the environmental impact of our products, and of course, this is about reduction of carbon emissions, but it's also on the impact on air, on water, on biodiversity. And, so, I think that companies need to make sure that they have the in-house capabilities and the expertise to consider environmental sustainability aspects of their products and operations, and also make sure that this is visible and available to their partners.
Thomas (TPN): There are also increasing environmentally related adverse weather events impacting global industries. How are such adverse weather events impacting the global supply chain for excipients, and how might companies negotiate these sorts of challenges?
Williams (AstraZeneca): Supply chain resilience, as we've just been talking about, as Bram's just talked about, is fundamental to making sure, whether it's excipients or it's active ingredients, can really continue supply. We've seen issues in the east coast of the U.S., we've seen high temperatures, issues with flooding, and issues with high temperatures in other parts of the world, which can really disrupt production of materials’ production sites. Working in the fields can become a real risk in high-temperature environments, and so everything from individual workers in a raw material production setting through to factory settings, can be subject to disruption through high temperatures or indeed a lack of water availability as well. So, those changes in climate necessitate greater planning for resilience, and those dual-source paths maybe need to become triple-source.
But again, the assurance all the way through there that, seemingly two supply chain paths at Tier 1 or Tier 2 of the supply chain don't combine at Tier 3 is then a real challenge for us all to say. So, it all comes back to that traceability, that supply chain due diligence, that assures supply all the way through. But I think increasingly, businesses are looking to plan for these things, understand the risk at supply chain sites of things which we weren't exposed to 20 years ago, and so, new factors for us to consider, but ones that can be brought together with sound science and good quality insurance.
The Onshoring/Reshoring Debate
Thomas (TPN): Another issue that's been raised again, shall we say with a bit more gusto, is onshoring or reshoring to improve the supply chains. Where are we up to in terms of onshoring or reshoring at the moment, and what sort of impact is that having on the patient?
Williams (AstraZeneca): The onshoring or reshoring debate, and I'll start with the sustainability perspective, is a really interesting one. The disruptions in supply we've seen through the application of geopolitics is just shining another light on where we should be looking for sources of materials. Some, of course, are geographically limited in where they can be produced from and, so, there's restrictions there. But increasingly looking to synthetic alternatives to natural raw materials provides for onshoring opportunities, or just a greater geographical base to produce from. That, I think, is underpinning, then, the continuing supply of medicines to patients.
Onshoring for sustainability reasons, for carbon, I think there's real data needed in that space. What proportion of the overall carbon footprint of an excipient is formed by the transport of that material? I think the general evidence points it's a relatively small part. So, I think there's other factors that need to be considered probably more in the resilience of supply, the opportunity for synthetics, and certainly the reduction of impact on nature, which is largely becoming an associated issue along with climate now, and I think many companies are recognizing that to have healthy people, we have to have a healthy planet, and so nature and climate go together in that space.
Langley (gChem): From the economic side to actually manufacture these types of products, I see the industry basically in two-parts: So, you have the innovation side, which is patent-protected, and then you have the generic industry. I think the two are very different with respect to onshoring and the economics behind the possibility and the probability of that happening.
The innovators, you can see that the profit margins are still high because the investment's there, and the patent life supports that until they go off patent to become generics themselves. On this flip side, the generic industry, the margins, profit margins are very slim, and so, the infrastructure, in some of the countries now, for making, those types of products, has disappeared, basically. The large footprint manufacturer has been replaced over the years, and moved to different parts of the world, such as India and China, for example. Not just the final drug product, but the drug substance as well, the active materials.
So, you've got two things — you've got the drug product, and in some cases, the API that you need to manufacture and onshore, and I think it's going to be a challenge. I think maybe we’re slightly naïve to think that companies will invest there because the economics don't work, so you may then have to have big government support. to actually onshore all the physical products, not just the innovator one.
Moore (EXCiPACT): It's a very difficult question. I mean, obviously, if you want to onshore, then you've got to identify your supplier, as you were saying, Nigel, and then you're going to need to qualify them quickly. That in itself is not a trivial matter. You have to be assured that they've got the right quality standard on the excipient, that they are a genuine actor in the supply chain, and, of course, they demonstrate that they've implemented GMP and good distribution practice as well. All of that takes some time.
We’ve got guides and help available from the International Pharmaceutical Excipients Council, IPEC, to accelerate this and what we need, then, is to make sure that industry is using all of those tools to facilitate a quick approval of new suppliers, or re-approval of old ones maybe, but without any loss of quality in our process, or any compromise to patient safety. The good news is that those kinds of tools are available and we should be using them.
Baert (Lonza CHI): From a quality perspective, this may be an advantage of onshoring as it's important also to perform on-site visits to make sure that the supplier meets the GMP requirements, the standards that are needed to ensure safe products, and having, of course, a supplier that is nearby can facilitate this type of quality activity. So, from that perspective, it's a positive thing, and it may result in improved quality of medicines for patients.
Future Expectations
Thomas (TPN): What might we expect in the near future to help ensure the sustained availability of excipients in your opinion?
Moore (EXCiPACT): There's been some exciting news this year, driven out of the sad news around the falsification of excipients and the infant deaths that have occurred yet again, but what we are now seeing is that regulators around the world are taking heed of that, and they're starting to act. Regulators are starting to require the GMPs be applied to excipients globally and that the duty is of the drug product manufacturer to utilize excipients made according to GMP, and they have to gather the evidence that's been applied.
What I see as great there is that the regulators are actually listening to organizations like IPEC and EXCiPACT, because we have a lot of knowledge about what the excipient industry looks like, and the standards it's been applying. So, what we're seeing mirrors a little bit of what happened during COVID and development of those vaccines — the regulators, the pharmaceutical companies, the suppliers are all working together and facilitating and promoting patient safety as a theme. I think that's a great development. I certainly want to see that accelerate in the future, and that collaboration to work, because then we're working together, and that means we're stronger and patient safety is more assured.
Langley (gChem): So, I think that's an interesting connector for collaboration, I think it's not just in one part of the industry, I think it should be everywhere. I feel that if we're going to keep pace, certainly, with how the modalities are developing on the excipient innovation side, we just need to do that more and we need to find a mechanism — it needs to be consistent, not just in pockets of collaboration. There needs to be some sort of open dialogue and suppliers or manufacturers of excipients should be really seen by companies as part of their drug development process, not just simply where you buy or procure excipients where you need to have them. I think the dialogue should start very much earlier than that.
And then, there's lots of different grades of excipients, so, it's not one grade fits all, and I think that basic understanding is somewhat lost sometimes until it may be too late. For example, when you get to manufacturing and you're sourcing an excipient from somewhere else, a different type of grade that you used in your development, because it's no longer available then sometimes you come into problems. But, if collaboration had happened earlier and more closely, then that type of issue may go away. Again, we're talking here about the patient at the end, and to get the best treatment to a patient, the most stable drug, the most efficacious drug. product, then the whole process needs to come closer together. We had that, obviously, in COVID, it's all very much documented now. And Iain just commented on the regulatory side seems to be learning there, but I think there's still some learnings that we had during that time, that's transferable to all parts of our industry.
Baert (Lonza CHI): I would like to echo, indeed, the need for collaboration and communication, and I truly think that if excipient producers, excipient users, and regulators all work together, the best is yet to come.
Williams (AstraZeneca): And I'd agree with that. The work of IPEC, or the work of EXCiPACT, the work of PSCI, is fundamentally important, that collaboration across different parts of the industry, but then there's different parts coming together as well, to just set those consistent standards, a clear expectation on the whole of the supply chain, but ultimately, that's underpinned by the transparency, the due diligence, the certifications, which provide a safe way for the future.
Reference
CPHI Online. Challenges to the Sustained Availability of Excipients. Panel Discussion at CPHI Frankfurt 2025, Oct. 29, 2025.
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