Susan Haigney

 managing director, Arcinova, a Quotient Sciences company, about what makes a contract development and manufacturing organization (CDMO) that offers end-to-end service beneficial to sponsor companies and how digital technologies are changing the industry.

PharmTech: How is early development of drug products enhanced by a CDMO that offers end-to-end services?

Dowdeswell (Arcinova): I think to some extent, this depends a little bit on who you're doing the work for. So, if I was to take a small biopharma company, for example—and they're important because they own the majority of clinical molecules in early clinical development—typically, that sort of company has limited resources to conduct that sort of work themselves. So, they outsource heavily. They perhaps have a limited number of people who are really going to be in a position to manage their service providers. So, that really brings you to the first benefit, but actually having a single partner reduces the complexity you have in managing multiple partners; you have a single point of contact across the continuum.

And, actually, there can be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without you having to get in the way of communication because they're part of the same company, there's no confidentiality issues.

It also means that maybe there's some work that can be overlapped. So, you can start work on a drug product before you've finished all the work on the drug substance, which might not be quite so easy when you have separate parties.

It may be an example to bring that to life. One of the things that we find here is that we can have great communication between the team that's working on the API around the material form of the drug substance, with the drug product team who's doing the work to translate that into a viable drug product. So [there’s] that interplay between how do we optimize the drug substance [and] how does that feed into what we're doing with drug product that can actually bring you to stronger technical outcomes?

I think in our particular case as well, because we're part of Quotient, we're able to go further downstream, into clinical work. The main benefits of that continuity of work through a single provider brings those key benefits, reduction in complexity, especially those smaller companies, reduction in time, which can be quite meaningful, and the reduction in the total cost of ownership.

What role do artificial intelligence (AI) and digital technologies play in accelerating drug discovery and improving manufacturing efficiency?

One of the clearest examples of how digitalization and AI are changing drug discoveries is the use of AI to help design new molecules that target a specific protein site. Now that is quite effective in tailoring a drug to the activity or molecule’s activity you hope it will have, but it has an unexpected consequence in that the number of synthetic steps is increased quite dramatically with that approach. I have some data that shows around the year 2000 there was a paper published by Pfizer and AZ [AstraZeneca] that showed the average number of synthetic steps to get to an API was eight. Round about 2020, you do the same analysis, and you see that number of steps has almost doubled—so, it's like 14 or 15.

And earlier this year, I found some more data, which suggested that the new molecules coming out of novel approaches to drug discovery have often in excess of 30 steps of chemistry to get to the target. So that is a really dramatic step change—that over the past 25 years, you've gone from eight to 30 steps, and that's quite an unexpected consequence. CDMOs are going to have to find a way to deal with that. Now, the time that we have available for CMC [chemistry, manufacturing, and controls] is not going up. In fact, if anything. [it] is coming down. So, you have more complexity, more work to do on the API synthesis. We can leave aside the problems that you have in drug delivery beyond that. But just for the API synthesis, you have to find a way to get all of the work done on CMC and building the synthesis towards providing the small-molecule API in the same time. So, you have to find ways to do that much more efficiently, much more quickly.

One of the things that we've been looking at is around the use of digital twins. We're not alone in doing that, but one of the reasons we've done that work is because it gives us a really great pathway to look at how do we move from the small-scale lab experiment into the initial scale up, which might be to a small kilo lab, 5, 10, 20 liters, and then take that further into the next scale, which might be 100-, 150-, 200-liter scale. And even then, how do we provide data that enable a customer or a future service provider to take that further? So, we've done that work to enable us to model how the reactor is going to behave, how the kinetics of the reaction are going to behave, to enable and facilitate that scale up. And we actually did that. It was part of a sustainability push, originally, that we wanted to be able to do this in a quicker fashion, that we're using less resources to get to the same endpoint. But when you tie that into the complexity part, the amount of work you've got to do, that starts to become essential.

The difficulty in the work that we did was to look at the data architecture. The way that you receive the data from all of the different sensors, because it's not standardized today, requires a lot of data manipulation/adjustment to get it into a format where you can do the modeling. Here's where we're planning on bringing AI in, because AI can help do that data manipulation work in a much smarter, quicker [way], frankly. Quicker is the key here; [AI] enables us to get that modeling done much more quickly, which starts to build this then from a single product or single reaction solution into something that's much more of a platform that you can use across the board.

Some of the other advantages you have is how you can also look at operating in batch or continuous and attend on a particular stage of development. You might want to change that [to] be more appropriate [at] a certain stage of development, to do it continuous and later fit to batch, because that fits a large-scale CD, most manufacturing assets.

I think, as an industry, that's maybe a microcosm of the challenges we face. There's an inconsistency around the state of digitization, and not just company-to-company, but asset-to-asset within companies, because different assets have different ages and different ability to support digitalization.

Innovation, the lack of standardized data architecture, is something that we've seen, really in a microcosm, but [also on] a macro level [and] is something everybody faces. And I think the third one, I'm pretty sure, is a [challenge] across the industry as well, [which] is the availability of expertise. Is there a suitably qualified workforce? Do we have access to the right people that can really support and drive digital initiatives, and, in fact, even who fully understand the true potential of what could be done? I think that's one of the key challenges that, as an industry, we're still coming to grips with.

How is the sector reimagining supply chains to protect against rising tariffs, geopolitical shocks, and global disruptions?

Quite frankly, at the moment, nobody knows. There's a huge amount of change around tariffs and what's happening with some of the other geopolitical situations. And certainly, I don't look to base strategy on social media posts without really understanding how that is going to be implemented. But I think overall, this is part of an ongoing regionalization trend that has really been driving for quite some time, certainly over the past 10 years, this has been happening certainly for innovative pharma. So, companies working in the innovative space, their focus has moved away slightly from just being let's get things done at the lowest cost, which meant moving to Asia, to a realization that their success is much more dependent upon getting their drug advancing through the clinic and hopefully to market in a timely fashion.

Not being first to market or being delayed is a real hit on their revenue. It's a real hit on the business case for developing the drug in the first place. So we're seeing them move away from a cost-first basis to look at how do they best ensure their drug gets through that. The way they do that is by making sure that their CDMO providers are underpinned by strong science, are able to provide good data, are able to execute a plan, have no compromise on quality, are able to really communicate within a very optimal fashion, depending on what that means for an individual organization. Overall, finding that they are able to get more security of supply and more security of delivery.

You can really see that in the past 10 years, the CDMO industry has had quite a revival, and a number of companies that are public demonstrate that really well across Europe and United States. So, I see the trends, the questions around tariffs, BIOSECURE, re-emerged again. The geopolitical factors around the over-dependence on China, I just see that simply accelerating that trend. Because I think our industry has been moving that way anyway. This just maybe makes people much more conscious of it … What it means for us is we have to be consistent or continually re-evaluate what we offer as services to understand [if what we are offering] is still addressing customer problems. What aren't we doing that we should be doing? Are we relevant? Are we going to remain relevant in the future? So really having that continuous dialog with our customers and future customers about what do we need to be doing to really be giving you what you need.

Articles

End-to-end services provided by CDMOs streamline drug development for small biopharma companies by reducing complexity, time, and costs. These organizations facilitate seamless communication and collaboration between drug substance and product teams, enhancing technical outcomes. Digital technologies, including AI and digital twins, are revolutionizing drug discovery and manufacturing by improving efficiency and enabling rapid scale-up. However, challenges such as data standardization and workforce expertise persist. The industry is also adapting supply chains to mitigate geopolitical risks, focusing on regionalization and ensuring timely drug advancement over cost reduction.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, discusses what makes a CDMO that offers end-to-end service beneficial. 

Outsourcing Partners Providing End-to-End Service

Sustainability and Stability in Excipients

Raw materials, such as excipients, play an important role in the overall finished drug product. These materials can keep the drug stable, assist in drug delivery in the body, and help with patient adherence. The expansion of the biologics market, according to Peter Freed, head of Global Pharma CTS, Roquette, has made excipient quality even more important to ensure protein integrity and formulation stability.

When it comes to sustainability, Reed points to plant-based excipients, eco-efficient manufacturing, and bio-based circular supply chains as ways to meet performance and environmental targets. Science-based metrics and transparent supply partnerships are also key.

® spoke to Freed to find out more about the importance of raw materials in the development and manufacture of pharmaceuticals. Click on the video above to watch the interview.

 in the Excipients zone at stand 8.0P24. 

Peter Freed is head of Global Pharma CTS, Roquette.

Editor's note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

Hi, my name is Peter fried. I'm the head of pharma customer Technical Support at Roquette. I lead a group of global scientists that help our customers solve problems, formulate new dosage forms and innovate.

Well, the rise of biologics makes Excipient quality and consistency vital for protein integrity and formulation stability. Therefore traceability and stringent quality control are now essential for compliance and patient safety. Roquettes, proletal mannitol and kleptos, Hydroxypropyl beta cyclodextrin maintain structure and performance throughout manufacturing and storage, so with integrated analytical and formulation expertise, rocket enables a more efficient and scalable development of stable biologics.

The focus on patient experience is driving innovation in taste masking and swallowability. Kleptos and ready like coat highlight how formulation science supports adherence and clean label designalso ethical. Methicel, Aqua coat, ECD coatings enable precision release for optimized outcomes and manufacturing efficiency. And lastly, a growing demand for plant based, sustainable excipients aligned with roquettes bio based innovation strategy.

So Pharma is shifting from cost driven to resilient, flexible supply chains, rockets, global networks strengthened by the qualcaps and IFF pharma solutions integrations ensure a multi regional manufacturing and reduce dependency on individual production sites. Also the company's digital traceability systems enhance visibility from raw materials to finished products. Roquette exemplifies how the sector is building robust future ready supply networks to withstand disruption.

Sustainability is a core strategic driver in roquettes farm operations and sourcing. Roquette leads with plant based excipients and eco efficient manufacturing, supporting a shift towards bio based circular supply chains, products such as ready lie code showcase how green innovation can meet both performance and environmental targets, and our company applies science based metrics and transparent Supply partnerships to help customers track and achieve ESG goals.

Yeah, cphi 2025. Is extremely exciting for Roquette. It marks the debut of roquettes unified health and pharma Solutions Group, and this is a milestone following the qualicaps and IFF pharma solutions, acquisitions and integrations. So we'll be there displaying under the banner united for better health, and Roquette will showcase our combined strength and excipients, APIs, drug delivery technologies and unique customer service. Our company looks forward to engaging in key industry themes such as AI, sustainable manufacturing, biopharma innovation and resilient supply chains, and it's really a great opportunity to demonstrate how three legacies have united to deliver faster, safer, more effective and more sustainable therapies for customers and patients.

Videos

Pharmaceutical Technology® spoke with Peter Freed, head of Global Pharma CTS, Roquette, about a variety of materials-related topics including protein stability, tablet coating, sustainability, and securing the supply chain. 

white pill capsule isolated on white background | Image Source: ©F16-ISO100 - stock.adobe.com

pened today, October 28, with conference sessions on a variety of topics and a wide range of companies exhibiting their products and services. Contract development and manufacturing organization (

 to showcase the expansion of its services in Europe with the anticipation of shorter lead times, more robust supply chains, and local support from pharma manufacturers. In particular, the company’s Croatian operations, is one of Europe’s largest capsule production sites, according to the company (1).

At stand 8.0T60 Zone Excipients, ACG is also exhibiting its gelatin capsule portfolio, which is now manufactured in Europe, and includes inhalation capsules, TiO

-free options, liquid-fill formats, and a cellulose-based capsule with a pH-independent profile for moisture-sensitive formulations. The company’s range of high- and ultra-high barrier blister packaging is also on display.

“ACG is driving sustainability through PVC free and design for recyclability thermoforming options, PVC and halogen free cold forming material and lighter weight materials. ACG’s CelluPod, a paper-based blister and Bio D, a biodegradable PVC film. ACG’s packaging materials are produced from premium and traceable raw materials and are fully compliant with global regulations, provides reliability and consistence in product quality,” Jochen Scheil, ACG’s Vice President Global Sales & Business Development said in a press release (1).

“Our focus is on being in Europe, for Europe, combining global expertise with local presence to deliver real value for our customers,” said Selwyn Noronha, CEO of ACG Capsules, in the release (1). “By strengthening our operations in Croatia, we’re increasing capacity, shortening lead times and enhancing supply chain resilience. Together with our integrated solutions and deep understanding of European standards, this investment ensures we remain a trusted partner, always at our customers’ side.”

How will innovation in outsourcing be discussed this year?

, a CDMO that specializes in formulation development, clinical and commercial manufacturing, and packaging, will be exhibiting and presenting this year. Bora CDMO president, J.D. Mowery, is participating in a panel discussion on the future of CDMO innovation. 

Beyond Traditional Markets: The Strategic Importance of Emerging Pharma Trends and CDMO Innovation

 explores the emerging trends shaping CDMOs and is scheduled for October 30 from 11:35 a.m. to 12:15 p.m.

2-part interview with Mowery to post on Thursday.

The company will also be announcing the expansion of its fill/finish capabilities in the CDMO Zone at Booth 6.0C90. In addition, the company’s Chairman and CEO, Bobby Sheng is a finalist for “CEO of the Year” in the 

. Sheng won “CEO of the Year” in 2020.

“Bringing leaders and ideas together under one roof to collaborate is critical to the future growth of our industry,” said Mowery in a press release (2). “This has been an exciting year at Bora, marked by global growth and strategic investments across our business. We’re eager to make the most of the connections and collaboration at CPHI and carry those insights back to our customers to further strengthen the value we deliver.”

“Our collaboration with Bora Pharmaceuticals for sterile fill and finish services truly distinguishes us from other biologic CDMOs,” Marc Goemans, chief commercial officer of Bora Biologics, emphasized. “It streamlines the client experience by allowing them to sign a single agreement to work with one team on one timeline, ensuring expedited project success from start to finish—consolidating expertise and rewarding collaboration to de-risk every project."

will be announced at the event’s opening ceremony on October 28 (3).

ACG. ACG Showcases Strengthened European Capabilities and Croatia Expansion at CPHI 2025. Press Release. Oct. 28, 2025

Bora Pharmaceuticals. Bora Pharmaceuticals Joins Global Pharma Leaders at CPHI 2025. Press Release. Oct. 27, 2025.

Mirasol, F. CPHI Frankfurt Reveals 2025 Pharma Awards Finalists for Bio/Pharma Development. PharmTech.com. Sept. 18, 2025. 

https://www.pharmtech.com/view/cphi-frankfurt-reveals-2025-pharma-awards-finalists-for-bio-pharma-development

CPHI Frankfurt commenced with diverse conference sessions and numerous companies showcasing their offerings. ACG highlighted its European service expansion, focusing on reduced lead times and enhanced supply chains, particularly through its Croatian capsule production site. ACG's exhibit includes a range of gelatin capsules and sustainable packaging solutions. Bora Pharmaceuticals is participating in discussions on CDMO innovation and expanding its fill/finish capabilities. The event emphasizes collaboration and innovation, with Bora's CEO being a finalist for "CEO of the Year" at the CPHI Awards, which will be announced at the opening ceremony.

ACG showcased the expansion of its European presence, and Bora Pharmaceuticals participates in a discussion about CDMO innovation.

Day One at CPHI Frankfurt Sees Announcements from ACG and Bora Pharmaceuticals

CPHI Frankfurt 2025: The Current API Market

APIs are a prominent and important part of a drug product. Pharmaceutical companies often source these materials from global API manufacturers, and qualifying these suppliers is integral to good manufacturing practices and regulations. A secure supply chain for these materials is also imperative.

With a variety of potential disruptions that may result from the current geopolitical climate, Dr. Weite Oldenziel, CEO of Ofichem, gives his perspective on why API suppliers should be qualified and how the current API market is handling the political landscape.

“Changes [in the API market] are always present, and we have to conclude that by far the majority of the APIs [are] being produced in Southeast Asia and predominantly in the countries India and China,” Oldenziel says. “There is a lot of talk about, say, reshoring, onshoring, near shoring. It is very difficult to substantiate this, to which extent this is happening. It is also very important to realize that no two APIs are alike. A low-volume, high-priced, proprietary API is completely something different than a large-volume, low-priced, generic API.”

“So, how is the sector reimagining supply chains? In general, I would say not that much,” Oldenziel says. “Things in the pharmaceutical supply chain are moving relatively slow. It is quite a conservative market where strict compliance with rules and regulations is very important. So, processes just move slow, and they can't anticipate on incidents in the world markets. Only when an incident has a more structural character… you will see that supply chains are affected.”

, which is happening from Oct. 28–30 in Frankfurt, Germany. You are welcome to visit their stand, number 11.0A89, zone API.

Click on the link about to watch the interview.

Dr. Weite Oldenziel is CEO of Ofichem, a fully integrated pharmaceutical company, both in drug substance and in drug product. He is a pharmacist and has a PhD in neurochemistry.

My name is Weite Oldenziel from a background. I'm a pharmacist and did a PhD in neurochemistry, and since almost 20 years, I'm now the CEO of the Ofichem Group, which is a fully integrated pharmaceutical company, both in drug substance and in drug product number two, sorry, yeah, very important for pharma manufacturers, of course, is the technical part. So the API supplier should fulfill all kinds of regulation. That's a no brainer. You things like GMP, things like an API registration, things like an asmf or a CEP. That's crystal clear. However, also very important, which is actually not part of the official supplier qualification, is that an API supplier also should be proactive. Should be supporting the pharma manufacturer should help and guide them, because only when they work together, the pharma manufacturer and the API supplier, they can bring the medicine to the market.

So yeah, what does the current API market look like? Of course, changes are always present, and we have to conclude that by far the majority of the APIs being produced in Southeast Asia and predominantly in the countries India and China. There are a lot of talks about, say, reshoring, on shoring, near shoring. It's very difficult to substantiate this, to which extent this is happening. It's also very important to realize that one API is not the other one. A low volume, high priced, proprietary API is completely something different as a large volume, low priced, generic API. So maybe not from a technical point of view, this API is different, but certainly from a commercial point of view.

So how is the sector re imaging, supply chains? This is quite a difficult question. In general, I would say not that much overall, and that has to do with the fact that things in the pharmaceutical supply chain are moving relatively slow. It's quite a conservative market where compliance and to remain in compliance is very important. So processes just move slow and they can't anticipate on incidents in the world markets, so only when an incident gets more like a structural character, yeah, then you really can see that supply chains are affected. What, for example, you've seen a few years ago when development. Proprietary APIs. More was reshored back to Europe and US. Or what you see now is at the Trump administration that there are more initiatives for maybe reshoring to US soil. But at this moment, that's not very tangible yet.

I'm very much looking forward to the cphi with enthusiasm. It's always very nice to reconnect with old friends and with acquaintances and to talk about the pharmaceutical world, which is our work, and which I'm really passionate about.

Pharmaceutical Technology® spoke with Dr. Weite Oldenziel, CEO of Ofichem, before CPHI Frankfurt 2025 to get his perspective on the API market and why it is important to qualify API suppliers.

The Benefits of End-to-End Services

Smaller biopharmaceutical companies that own the molecules in early clinical development and outsource most of their development and manufacturing operations, often have limited resources, according to Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company, and therefore might benefit from a contract development and manufacturing organization (CDMO) that offers end-to-end services.

“They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, where having a single partner actually reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum,” Dowdeswell explains. “There can actually be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without any barrier to communication because they're part of the same company, there's no confidentiality issues. It also means that maybe there's some work that can be overlapped. So, you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.”

Arcinova, a Quotient Sciences company, will be exhibiting at stand 5.1D104 , zone Contract Manufacturing and Services, at CPHI Frankfurt, being held Oct. 28–30, 2025.

Click the video above to watch the interview.

Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences company.

Christian Dowdeswell is an experienced commercial leader in the CDMO industry. A former scientist with a PhD in organic chemistry and a long track record in CDMO organisations, most notably VP Head of Commercial, Small Molecules at Lonza & Chief Business Officer, Drug Substance at Siegfried. His current role as Head of Arcinova builds on his extensive experience in Early Phase development across Drug Substance and Drug Product gained in prior roles.

Hello. So I'm Christian Dowdeswell. I am the MD of Arcinova, which is a part of quotient science is limited.

I used to be a scientist, but moved into commercial roles some 20 years ago, and have been in commercial leadership roles at a number of cdmos, most notably Lonzo, where I was head of commercial for the small molecules business for nine years. Spent some time as chief business offers Officer at seafree, before deciding that I wanted to return to where I started. So back with much smaller cdmos, which is in a roundabout way, led me to this new role leading Arcinova, which is an early phase drug provider, drug development provider, offering services across drug substance, drug product, global clinical trials, supply and answer adjacent services.

How is early development of drug products enhanced by a cdmo that offers end to end services?

I think to some extent, this depends a little bit on who you're doing the work for. So if I was to take a small biopharma company, for example, and they're important because they own the majority of clinical molecules in early clinical development, typically, that sort of company has limited resources

to conduct that sort of work themselves. So they outsource heavily. They perhaps have limited number of people who are really going to be in a position to manage their service providers. So that really brings you to the first benefit, but actually having a single partner reduces the complexity you have in managing multiple partners, you have a single point of contact across the continuum.

And actually there can be some really more tangible benefits than that. So where you have a single partner developing both your drug substance and drug product, and in fact, in some of the areas around it, what you can find is that they're able to talk to each other directly without you having to get in the way of communication because they're part of the same company, there's no confidentiality issues.

It also means that maybe there's some work that can be overlapped. So you can start work on drug product before you've finished all the work on drug substance, which might not be quite so easy when you have separate parties.

It may be an example to bring that to life. One of the things that we find here is that we can have great communication between the team that's working on the API around the material form of the drug substance, with the drug product team who's doing the work to translate that into a viable drug product. So that interplay between, how do we optimize the drug substance, how does that feed into what we're doing with drug product that can actually bring you to stronger technical outcomes as well?

I think, I think in our particular case as well, because we're part of quotient, we're actually able to go further downstream, actually into clinical work. But, but really the main benefits of that continuity of work through a single provider brings those key benefits, reduction in complexity, especially those smaller companies, reduction in time, which you know can be, can be quite meaningful, and the reduction in the total cost of ownership. So.

What role do artificial intelligence and digital technologies play in accelerating drug discovery and improving manufacturing efficiency? And what are some unresolved barriers to full adoption?

I think there's, there's actually quite a lot to unpack within that, but so I'll try and deal with it, with it through giving some examples of things that are happening, things that we've been looking at. So one of the clearest examples of how digitalization and AI is changing drug discoveries in the use of AI to help design new molecules that target a specific protein site.

Now that is quite effective in tailoring a drug to the activity or molecules the activity you hope it will have, but it has an unexpected consequence, in that the number of synthetic steps is increased quite dramatically with that approach. So I have some data that shows around about the year 2000 there was a paper published by Pfizer and AZ, I think that showed the average number of synthetic steps to get to an API was eight, round about 2020, you do the same analysis, and you see that number of steps has almost doubled. So it's like 14 or 15.

And earlier this year, I found some more data, which suggested that the new molecules coming out of novel approaches to drug discovery have often in excess of but 30 steps of chemistry to get to the target. So that is a really dramatic step change, that over the last 25 years, you've gone from eight to 30 steps, and that's whilst that's quite an unexpected consequence, cdmos are going to have to find a way to deal with that. Now, the time that we have available for CMC is not going up, in fact, if anything is coming down. So you have more complexity, more work to do on the API synthesis. We can leave aside the problems with that you have in drug delivery beyond that. But just for the API synthesis, you have to find a way to get all of the work done on CMC and building the synthesis towards providing the small molecule API in the same time. So you have to find ways to do that much more efficiently, much more quickly.

One of the things that we've been looking at is around the use of digital twins. We're not alone in doing that, but one of the reasons we've done that work is because it gives us a really great pathway to look at how do we move from the small scale lab experiment into the initial scale up, which might be to a small kilo lab, 510, 20 liters, liters, and then take that further into the next scale, which might be one, 150 200 liter scale. And even then, how do we provide data that enables a customer or a future service provider to take that further? So we've done that work to enable us to model how the reactor is going to behave, how the kinetics of the reaction are going to behave, to enable and facilitate that scale up. And we actually did that. It was actually part of a sustainability push, originally, that we wanted to be able to do this in a in a quicker fashion, that we're using less resources to get to the same endpoint. But actually, when you tie that into the complexity part, the amount of work you've got to do, that starts to become essential. And I think your question asked about some of the difficulties, you know, the difficulty in the work that we did was to look at the data architecture, the way that you receive the data from all of the different sensors, because it's not standardized today, requires a lot of data manipulation adjustment to get it into a format where you can actually do the modeling. So here's where we're planning on bringing AI in, because AI can help do that data manipulation work in a much smarter, quicker, frankly, quicker is the key here, why that enables us to get that modeling done much more quickly, which starts to build this, then from a single product or single reaction solution into something that's much more of a platform that you can use across the board. Some of the other advantages you have is that, by how you can also look at should be operating in batch or continuous and attend on a particular stage of development, you might want to change that might be more appropriate a certain stage, stage of development, to do it continuous and later fit to batch, because that fits a large scale CD, most manufacturing assets. So there's a lot there. I think, as an industry, that's maybe a microcosm of the challenges we face. There's a, there's a there's inconsistency around the state of digitization, and that not just company to company, but acid to acid within companies, because, you know, different assets have different ages and different ability to support digitalization.

Innovation, the lack of standardized data architecture, is something that we've seen, really in a microcosm, but a macro level, I think, is something everybody faces. And I think the third one, I'm pretty sure, is an industry across the industry as well, is the is the availability of expertise. Is there a suitably qualified workforce? Do we have access to the right people that can really support and drive digital initiatives, and, in fact, even who fully understand the true potential of what could be done. I think that's one of the key challenges that as an industry, we're still coming to grips with.

How is the sector reimagining supply chains to protect against rising tariffs and geopolitical shocks and global disruptions?

Yeah, I think that's, that's a question I get a lot, actually, and I probably play back a little bit the the answer that I quite often give which is the quite frankly, at the moment, nobody knows there's a huge amount of change around tariffs and what's happening with some of the other geopolitical situations. And certainly I don't look to base strategy on social media posts without really understanding how actually is that going to be implemented. But I think overall, this is part of a an ongoing regionalization trend that I think has really been driving for quite some time, certainly, certainly over the last 10 years, this has been happening where, certainly for innovative Pharma. So companies working in the innovative space, their focus has moved away slightly from just being let's get things done at the lowest cost, which meant moving to Asia, to actually a realization that their success is much more dependent upon getting their drug advancing through the clinic and hopefully to market in a timely fashion. Not being first to market or being delayed is a real hit on their revenue. It's a real hit on the business case for developing the drug in the first place. So we're seeing them move away from a cost first basis to look at how do they best ensure their drug gets through that, and the way they do that is by making sure that their cdmo providers are underpinned by strong science, who are able to provide good data, who are able to execute a plan, who have no compromise on quality, who are able to really communicate them within in a very optimal fashion, depending what that means for an individual organization and overall, finding that they are able to get more security of supply, more security of delivery of what they're asked, asking for by using Western providers. And you can really see that in the last 10 years, the cdmo industry has had quite a revival, and a number of companies have that are public demonstrate that really well across Europe and US. So I see the trends, the questions around tariffs, bio secures, re emerged again. You know, the geopolitical factors around

the over dependence on China, I just see that simply accelerating that trend. Because I think our industry has been moving that way anyway. This just maybe makes people much more conscious of it. For a company that can't get Nova, which is really an early phase company, what it means for us is we have to be consistent or continually re evaluating what we offer as service, services to understand is that still addressing customer problems, what aren't we doing that we should be doing? Are we relevant? Are we going to remain relevant in the future? So really having that continuous dialog with our with our customers and future customers about what do we need to be doing to really be giving you what you need.

What are you looking forward to most at CPHI Frankfurt?

CPHI, I think have a love hate relationship with it. I've been going for 25 years, and perhaps, as I answer, you can see why I have a love hate relationship with it. I actually think the timing couldn't be better. I am less than three months in a new role with an organization that's been been rebranded is based in the organization as well, so that timing almost couldn't be better, because I get the chance to meet with a huge number of customers, and hopefully future customers, and actually other people industry, and really start to test myself firsthand. What are we doing?

Is that addressing your needs is, are we actually providing what you need to what aren't we doing that we should be doing? Basically what I talked about in the previous answer, it's a perfect opportunity to do that. I mean, it's a great place to connect with old friends, to meet up with other people in the industry who have an incredible amount of knowledge.

I think I'm not alone. I think a lot of people go to cphi and are very guilty of burning the candle at both ends. So You're up early for breakfast meetings and you're out late having having dinner and after dinner events. So it's a very tiring event, and that's why I have a love hate relationship with it. I always come back exhausted because I have burnt the candle at both ends, but it's always worth it. I always come back with with, you know, a huge amount of new information, new people met old people reconnected with so it's actually a fantastic event. It's just really tiring.

Pharmaceutical Technology® spoke with Christian Dowdeswell, managing director, Arcinova, a Quotient Sciences Company, ahead of CPHI Frankfurt 2025 to find out what makes an end-to-end service provider beneficial to sponsor companies and how digital technologies are changing the industry.

3d rendering of radioactive intravenous drug using a needle and syringe to inject a drug | Image Credit: ©Love Employee – stock.adobe.com

Radiopharmaceuticals (RPs) are driving breakthroughs in oncology (1). This class of medicine, unique for containing both a radioactive isotope and a targeting molecule, offers unprecedented precision (1). By delivering radiation directly to tumor sites, RPs minimize damage to healthy tissues, resulting in fewer side effects compared with traditional cancer therapies (1,2). For pharmaceutical scientists, understanding the currents of innovation, regulatory evolution, and logistical challenges defining this field is crucial for accelerating the next generation of targeted treatments.

How is precision medicine developed via theranostics and radio drug conjugates?

The strength of radiopharmaceuticals comes from their inherent theranostic potential—combining precise diagnosis and targeted therapy (1). The targeting molecule binds to a specific receptor on a cancer cell, carrying the radioisotope straight to the disease site (1). This approach allows developers to see the disease using a diagnostic tracer and treat it in a highly targeted, image-guided manner (1).

Innovation is currently driven by the evolution from classical external beam radiation therapy (EBRT)—which delivers radiation externally—to systemically injected radiopharmaceutical therapies (2, 3). This systemic approach has been influenced by advances in antibody-drug conjugates (ADCs) (2). Radio drug conjugates (RDCs), in which a radio ligand (the element that introduces radiation) is conjugated to an antibody, allow for systemic administration and focused delivery, much like the "magic bullet" concept by Paul Ehrlich, who believed a therapy could be created to seek out specific agents that cause disease (2, 4). This RDC chemistry, linking the radio ligand to the antibody, remains an evolving opportunity to improve therapeutic activity (2, 5)

This technology is showing proven treatment effects in difficult-to-treat cancers, such as prostate cancer and neuroendocrine tumors (NETs) (1,6). Next-generation pipelines are exploring specific targeted agents, including the development of beta-emitting Lutetium-177 radiolabeled somatostatin type 2 (SST2) receptor antagonists and Iodine-125 radiolabeled Poly (ADP-ribose) polymerase inhibitors (PARPi) targeting tumor DNA (6).

How are regulations optimizing dosage and dosimetry?

As RPTs transition from traditional concepts to systemic therapeutics, regulatory bodies are adapting. FDA has published draft guidance on 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

 to assist sponsors in identifying optimized dosages (2,5). This guidance document acknowledges that while RPTs share characteristics with EBRT, fundamental differences in physical properties and treatment delivery lessen the applicability of historical EBRT-derived, organ absorbed dose limits (5).

Another trend is the permission to study administered activities that result in absorbed dosages exceeding EBRT organ tolerances, provided there is adequate rationale (3,5). This shift highlights the need for a deeper, empiric determination of RPT-specific organ tolerances and full assessment of dose-response relationships (5).

The FDA guidance emphasizes that drug developers must have a better understanding of pharmacodynamics, potential toxicity liabilities, therapeutic window, and dosimetry (2,3). Clinical trials must include safeguards, such as appropriate participant selection, trial design, safety monitoring, and radiation dosimetry evaluation (5).

Furthermore, understanding the biology is paramount; researchers are still in the early stages of identifying which tumor types or molecular cohorts are most sensitive to radio ligands and how resistance develops (2,5). This necessitates the use of robust preclinical models, such as clinically annotated patient-derived xenograft (PDX) models, and real-world data linked to deep molecular analysis (exome sequencing, proteomics) to inform patient stratification and clinical trial design (2). PDX models represent biology by placing tissue from a human into an animal; therefore, simulating human clinical trials into animals (2).

How are logistical and supply chain vulnerabilities overcome?

Despite clinical promise, the development and delivery of RPs face logistical challenges (1). The global demand for these treatments is rising (1,7); however, manufacturing capacity is limited. Supply is dependent on imports of key radionuclides and materials—such as high-assay-low-enriched uranium (HALEU) used for research reactors—often sourced from geopolitically sensitive areas (1,7).

Furthermore, the short half-life of radioisotopes complicates manufacturing and logistics immensely; often, these medicines must be produced and administered on the same day. Any transport or production delay can lead to wasted product or cancelled patient procedures (1,2).

To mitigate these risks and accelerate development, industry collaboration is key. Partnerships, such as the strategic global alliance between Medicines Discovery Catapult (MDC) and Crown Bioscience, are creating fully integrated preclinical workflows (1,3). This collaboration combines MDC’s expertise in radiochemistry, high-resolution imaging, and multi-omic tissue analysis with Crown Bioscience’s preclinical oncology models, creating a seamless pathway to generate high-quality translational data and de-risk assets for investment (1,3).

Simultaneously, regulatory bodies, such as the European Medicines Agency (EMA), are tackling supply vulnerabilities by recommending enhancing domestic production capabilities (e.g., EU-based HALEU enrichment), diversifying sources, and harmonizing transport procedures (7).

The collective efforts across innovation, regulation, and supply chain resilience underscore a determined push to ensure that radiopharmaceuticals fulfill their potential and deliver better outcomes for cancer patients worldwide (1,2,6).

Haigney, S. Collaborating on the Development of Radiopharmaceuticals. 

https://www.pharmtech.com/view/collaborating-on-the-development-of-radiopharmaceuticals

Haigney, S. Why Radiopharmaceuticals Are Ideal for Treating Cancer. 

Pharmaceutical Technology Trends in Formulation 

https://www.pharmtech.com/view/why-radiopharmaceuticals-are-ideal-for-treating-cancer

Haigney, S. Medicines Discovery Catapult and Crown Bioscience Create Alliance for Radiopharmaceuticals. PharmTech.com. Sept. 12, 2025. 

https://www.pharmtech.com/view/medicines-discovery-catapult-and-crown-bioscience-create-alliance-for-radiopharmaceuticals

Science History Institute. Paul Ehrlich. https://www.sciencehistory.org/education/scientific-biographies/paul-ehrlich/ (accessed Oct. 27, 2025).

Haigney, S. FDA Releases Guidance on Oncology Therapeutic Radiopharmaceuticals. PharmTech.com. Aug. 19, 2025. 

https://www.pharmtech.com/view/fda-releases-guidance-on-oncology-therapeutic-radiopharmaceuticals

Barton, C. Frontrunners in Next-Generation Radiotherapeutics. 

https://www.pharmtech.com/view/frontrunners-in-next-generation-radiotherapeutics

Barton, C. EMA Is Tackling Vulnerabilities in the Supply Chain of Radiopharmaceuticals. 

. June 4, 2025. https://www.pharmtech.com/view/ema-is-tackling-vulnerabilities-in-the-supply-chain-of-radiopharmaceuticals

Radiopharmaceuticals (RPs) are revolutionizing oncology by offering precise, targeted treatment with minimal side effects. These therapies combine radioactive isotopes with targeting molecules, allowing for direct delivery to tumor sites. The field is advancing through innovations in theranostics and radio drug conjugates, which enhance diagnostic and therapeutic capabilities. Regulatory bodies are adapting to optimize dosages and dosimetry, while addressing logistical challenges such as supply chain vulnerabilities. Collaborative efforts are crucial to overcoming these hurdles and ensuring the successful development and delivery of RPs for cancer treatment.

Radiopharmaceuticals are allowing for the targeted treatment of cancers, but they do pose challenges. 