In the run-up to CPHI Milan, we hear from industry experts on how expectations of development and manufacturing partners are evolving. It’s no longer just about having the right facilities or delivering against a brief. Sponsors want partners who can offer honest advice, spot problems early and help guide a programme from initial development through to commercial manufacture.
In this roundtable, Chris Davison, CEO of Centrix Pharma Solutions; Campbell Bunce, Chief Scientific Officer at Abzena; Britton Jimenez, SVP, Sales and Marketing at Codexis; Tom Stephens, Head of Business Development and Interim Head of R&D at Ofichem; and Jakub Knurek, Marketing Specialist at Mabion S.A., share their perspectives on how expectations are changing, where projects still lose valuable time and what it takes to build stronger, longer-term partnerships in an increasingly complex market.
Chris Davison, CEO of Centrix Pharma Solutions
Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?
The biggest shift I see is from transactional outsourcing towards genuine partnership. Sponsors are no longer looking solely for providers who can execute a defined piece of work. They increasingly expect development and manufacturing partners to contribute expertise, challenge assumptions and help shape the path forward.
This is being driven in part by funding pressures. Capital is more precious than ever, which means there is less tolerance for avoidable delays, unnecessary development work or technical decisions that create challenges later in the programme. As a result, sponsors want partners who can bring manufacturability, scalability and commercial considerations into the conversation much earlier, whilst remaining adaptable as programme needs evolve.
The most valuable partners are those who help customers make better decisions, not just complete activities. Success increasingly comes from aligning around the end goal and ensuring every step moves a programme closer to delivering a viable medicine to patients.
Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?
Projects often lose momentum when development is treated as a series of isolated technical activities rather than an integrated journey towards a commercially viable medicine. Teams can become focused on achieving the next milestone without fully considering how that work contributes to the ultimate objective.
The most effective programmes start with the end in mind. That means understanding the patient need, product profile, material characteristics, manufacturing strategy, regulatory requirements and commercial objectives, then using that understanding to guide decisions throughout development.
It is not necessarily about adding more time or cost upfront. It is about ensuring the right experiments are performed at the right time for the right reason. When challenges emerge, successful partners escalate them early, explain the impact, outline options and recommend a path forward rather than simply reporting a problem. Significant value comes from connecting scientific, manufacturing, regulatory and commercial considerations from the outset.
What shifts in customer priorities do you expect to dominate conversations at CPHI this year and what do they tell us about where the market is heading?
I expect conversations at CPHI to be dominated by three themes: capital efficiency, risk reduction and resilient supply chains. Funding remains challenging for many organisations, which means every investment decision is being scrutinised more carefully. Sponsors are looking for ways to use resources effectively while continuing to advance programmes at pace.
At the same time, security of supply remains a major consideration. We often associate this with commercial products, but reliable supply can be just as critical during clinical development, where delays can have significant consequences for timelines and costs.
These trends point towards a market that increasingly values partners who take ownership of outcomes rather than simply completing contracted activities. Sponsors are looking for organisations that understand their objectives, proactively identify risks and help navigate complexity. That shift naturally favours longer-term, more strategic partnerships built on shared purpose and trust.
What will distinguish the most successful development and manufacturing partners over the next few years?
The most successful partners will be those that act as a genuine extension of their customers’ teams. Technical expertise will always matter, but expertise alone is not enough. Customers increasingly need partners who understand the objectives they are trying to achieve and are prepared to make recommendations, challenge assumptions and help navigate difficult decisions.
Success in drug development depends on bringing together scientific, manufacturing, quality, regulatory and commercial perspectives. Organisations that can connect these disciplines effectively will be best placed to help customers avoid unnecessary risk and make informed decisions throughout a programme.
Ultimately, the differentiator will be a mindset of ownership. The best partners are invested in achieving successful outcomes, not just delivering activities. When a partner understands the purpose behind the programme and is committed to helping achieve it, stronger collaboration, better decision-making and better results typically follow.
Campbell Bunce, Chief Scientific Officer at Abzena
Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?
The biggest shift is that capacity alone no longer wins work. Quality and compliant facilities are now treated as table stakes, and customers want to feel assured of on-time delivery, every time. Industry surveys show that reliability, execution, and cost competitiveness are now key differentiators, fostering confidence in choosing partners.
Alongside that, sponsors want fewer handoffs. For complex modalities like ADCs and AOCs, they increasingly ask for antibody, linker-payload, conjugation, analytics and ideally fill-finish under one quality system, because every interface between vendors are points of erosion of knowledge and extended timelines. Geography has also become a live selection criterion, with BIOSECURE and tariff pressure pushing programs toward US and European conjugation capacity. And expectations of scientific honesty have risen sharply, customers want a partner who will tell them early that a design won’t scale, not one that quietly runs the campaign anyway.
Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?
Honestly, the majority of “lost time” isn’t lost in the GMP suite, it’s lost at the handoffs. Tech transfer is the classic offender. Industry analysis suggests that the majority of biologics transfers hit significant timeline deviations, with the usual culprits being incomplete process characterization, analytical method gaps between development and QC, and reactive comparability planning. Analytical methods, especially potency assays, sit on the critical path far more often than people expect.
The other big one is deferred manufacturability thinking. If you pick a lead on potency data alone and only later discover the conjugation chemistry aggregates, or that your oligo loading ratio wrecks clearance, you’re re-engineering a molecule that’s already in tox.
So, what should partners do differently to avoid this issue? They need to bring manufacturing and analytical development into lead selection, not after it, and run developability and platform-fit assessments early. There needs to be a transfer of tribal knowledge: the deviations, the operator observations, the reasons behind choices, not just the batch record. Agree on a risk-ranked gap register up front and build engineering runs in rather than hoping to avoid them.
What shifts in customer priorities do you expect to dominate conversations at CPHI this year, and what do they tell us about where the market is heading?
I’d expect four themes to dominate. First, Resilience & Geography: Onshoring, BIOSECURE fallout and tariff exposure have made supply-chain origin a board-level question, not just a procurement footnote.
Second, Cost Discipline Meeting Complexity: Sponsors are more cost-sensitive while the molecules get harder, so conversations turn quickly to COGS, yield and how early design choices lock in expense.
Third, AI: which the organizers flag as touching manufacturing optimization, quality, compliance and logistics. I expect plenty of enthusiasm alongside healthy skepticism about what’s actually validated. Fourth, Sustainability: this year has a dedicated summit aimed at progressing from rhetoric to practical action.
Underneath all of it sits the end-to-end versus expert-led debate, which I think points us to the market consolidating around CDMO partners who combine specialist depth in hard modalities with enough integration to remove handoffs, with proven resilience. Buyers are optimizing for certainty now, not necessarily the cheapest quote.
What will distinguish the most successful development and manufacturing partners over the next few years?
Over the next few years, three themes will distinguish the most successful CDMO partners. The first will be proving delivery rather than describing it. There seems to be a discrepancy in survey data where on-time delivery is the top selection criterion yet sponsors rank CDMOs’ actual performance on it near the bottom. Credible schedule-adherence data puts manufacturing partners ahead of those that only talk about it.
Second will be genuine technical depth in the difficult modalities. ADCs, AOCs, bispecifics & radioconjugates punish generalists because controlling DAR, managing oligo loading ratios and pre-annealing behavior, and building orthogonal analytics for these molecules is specialist work. Partners with proprietary tools and real problem-solving scar tissue will keep beating those who are just offering capacity.
The third is integration with judgment. End-to-end support matters, but only when the organization uses the knowledge it holds by feeding manufacturability into design, flagging risks early, and behaving like part of the customer’s team rather than a vendor. Add financial stability and transparent governance, and that’s the profile. The winners will be the ones sponsors trust to protect their timeline.
Britton Jimenez, SVP, Sales and Marketing at Codexis
Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?
Pharma and biotech companies are increasingly looking beyond capacity and execution when selecting development and manufacturing partners. Today, they expect partners to contribute strategic expertise that helps de-risk programs, accelerate timelines, and create a clear path to commercialization. In areas such as RNA therapeutics, advanced biologics, and complex APIs, sponsors want collaborators who can solve manufacturing challenges early rather than simply execute predefined processes.
At the same time, expectations around scalability, sustainability, and data-driven decision-making are rising. Sponsors are seeking partners with platform technologies, advanced process development capabilities, and digital tools that can improve predictability as programs move toward larger patient populations. The relationship is becoming more collaborative and integrated, with successful partners acting as extensions of internal teams and helping sponsors make better decisions throughout development and manufacturing.
Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?
Many projects still lose momentum when manufacturing considerations are introduced too late in development. Processes that perform well at laboratory scale often encounter challenges during scale-up, technology transfer, or commercial readiness assessments, resulting in delays, rework, and additional costs.
Development and manufacturing partners can help prevent these issues by bringing commercialization thinking into programs earlier. This includes evaluating scalability, manufacturability, raw material requirements, analytical strategies, and regulatory considerations from the outset. Greater transparency and stronger communication between sponsor and partner teams always play an important role in reducing risk.
Another opportunity lies in leveraging platform technologies and data-driven process development approaches that enable more predictable scale-up. Partners that combine technical expertise with proactive program management can help identify potential obstacles earlier, allowing development teams to maintain momentum and focus resources on advancing therapies rather than solving avoidable manufacturing challenges.
What shifts in customer priorities do you expect to dominate conversations at CPHI this year and what do they tell us about where the market is heading?
We expect conversations at CPHI to focus heavily on scalable manufacturing, supply chain resilience, sustainability, and the growing role of digital technologies in development and production. As therapeutic pipelines become more complex, companies are looking for manufacturing approaches that can support commercial scale without sacrificing quality, speed, or efficiency.
For emerging modalities such as RNA therapeutics, the discussion is increasingly shifting from scientific feasibility to commercial viability. Developers want to understand how manufacturing platforms will support larger patient populations, evolving regulatory expectations, and long-term supply requirements.
Collectively, these priorities indicate a market that is moving toward greater operational maturity, with companies placing increasing emphasis on manufacturability, scalability, and strategic partnerships that can support programs from early development through commercial production.
What will distinguish the most successful development and manufacturing partners over the next few years?
The most successful development and manufacturing partners will be those that combine deep technical expertise with the ability to help customers navigate increasing therapeutic complexity and reach into untouched markets. Strong execution will remain essential, but differentiation will come from providing solutions that improve speed, scalability, quality, and long-term commercial success.
Technology platforms will play an increasingly important role. Whether through advanced biocatalysis, next-generation RNA manufacturing, continuous processing, or digital tools that improve process understanding, customers are looking for innovations that deliver measurable value beyond traditional outsourcing models.
Equally important will be collaboration. Sponsors want partners that communicate transparently, anticipate challenges, and contribute strategic insight throughout the development lifecycle. Being an order taker is no longer an option. Organizations that can serve as true problem-solving partners, while continually investing in innovation, quality systems, and manufacturing flexibility, will be best positioned to support the next generation of therapeutics and drive long-term growth.
Tom Stephens, Head of Business Development | Interim Head of R&D at Ofichem
Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?
I think companies are expecting far more from their partners than they did even a few years ago. Previously, a client might come with an API or FDF, a timeline and a fairly defined objective, and the role of the CDMO was largely to execute. Increasingly, that’s not what I’m seeing.
Many biotech companies are operating with very lean teams. They may have excellent science and a strong clinical plan, but they don’t necessarily have large manufacturing, regulatory or supply chain functions behind them. As a result, they’re looking to their partners to bring a broader perspective to the table. What I hear more often now is not “Can you do this?” but “What are we missing?” or “What would you recommend?”
I also think there’s much less tolerance for surprises. Customers want transparency, they want realistic timelines, and they want difficult conversations early rather than explanations later. The programmes themselves haven’t become any less challenging, but expectations of what a development and manufacturing partner contributes beyond the technical scope have certainly increased.
Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?
One area where projects still lose momentum is in the transition between development stages (Phase I to II or Phase III to commercial). Information that appears sufficient at the outset often proves incomplete once a programme reaches a regulatory review, technology transfer or scale-up phase. The resulting questions are rarely difficult to answer, but they can introduce weeks or months of delay that could have been avoided through stronger planning earlier in the programme.
I also think the industry sometimes waits too long to involve the right expertise. Regulatory strategy, manufacturing strategy and supply chain strategy are often treated as separate conversations when, in reality, they are closely connected. Decisions made in one area inevitably influence the others.
Perhaps the biggest opportunity lies in how sponsors and partners work together. The most successful projects are usually those where technical and regulatory discussions begin long before manufacturing starts. When both parties develop a shared understanding of the process, the facility, the documentation strategy and the eventual filing route, decisions tend to be made more confidently and progress is far more predictable.
What shifts in customer priorities do you expect to dominate conversations at CPHI this year and what do they tell us about where the market is heading?
One thing I’ve noticed is that customers are taking a much longer-term view than they were a few years ago. The discussions still start with development, manufacturing and timelines, but they quickly move into questions around future regulatory expectations, supply chain resilience and commercial readiness.
I believe it is partly because the environment is changing. We’re seeing regulatory frameworks evolve in different markets, we’re seeing ICH guidance continue to develop, and companies are becoming increasingly aware that decisions taken during development can create opportunities or constraints later.
I don’t think anyone is expecting a crystal ball from their partners. What they do expect is foresight and an honest assessment of where potential challenges may emerge. To me, that tells us the market is maturing. Customers aren’t simply buying a service anymore; they’re looking for partners who can help them make better decisions over the life of a programme.
What will distinguish the most successful development and manufacturing partners over the next few years?
Many development companies are intentionally lean and don’t have large CMC, regulatory, manufacturing or supply chain teams supporting every programme. What’s interesting is that they’re increasingly engaging CDMOs in much the same way organisations engage consulting firms, bringing in expertise and experience that they don’t wish to build internally but which are essential to moving a programme forward.
As a result, I think the most successful partners will be those that contribute beyond execution. Technical capability is expected, but the real differentiator will be the ability to help clients navigate decisions, anticipate challenges and provide perspective across the broader development journey.
In many ways, the CDMO is becoming a temporary extension of the organisation itself, contributing to programme direction rather than simply delivering a predefined scope of work. The partners that combine technical excellence with sound judgement and a genuinely collaborative approach are likely to be the ones that stand out over the next few years.
Jakub Knurek, Marketing Specialist at Mabion S.A.
Where are pharma and biotech companies’ expectations of development and manufacturing partners changing most quickly?
Much depends on the individual project, but I see two areas where expectations have changed particularly quickly.
The first is the growing importance of scientific quality and expertise. In biologics development, sponsors are increasingly looking beyond equipment lists, specific technologies or available bioreactor capacity. They want to understand who will actually work on their molecule, how experienced that team is with the relevant modality, and whether the partner can solve problems when the development path becomes more complex than originally expected. Speed remains extremely important, particularly as companies compete to reach the clinic and ultimately the market ahead of competitors, but speed without the right scientific decisions can be very expensive.
The second change is the return of long-term partnership thinking. During the pandemic, the priority was understandably to secure solutions and capacity quickly. Today, biologics development is returning to its more typical lifecycle, which can extend for a decade or more from lead molecule selection through clinical development and commercialization.
Changing a manufacturing partner halfway through that journey can mean repeating technology transfer, qualification and comparability work. It can cost both time and money. That is why sponsors are becoming much more selective when choosing a CDMO.
I sometimes compare it to a marriage: both sides need to believe that the relationship is worth investing in. The strongest partner should be able to support the molecule through process and analytical development, clinical manufacturing, scale-up and, ultimately, commercial production. This long-term approach is increasingly important to Mabion as well, particularly as we expand our activities from the traditional CDMO model toward co-development partnerships.
Where do projects still lose unnecessary time or momentum, and what could partners be doing differently to prevent that?
Technology transfer remains one of the points where projects can lose the most time. It is also one of the moments when the difference between an average contractor and a very strong development partner becomes visible.
A process that works well at one site cannot simply be copied into another facility. Differences in equipment, scale, process architecture, analytical platforms or operating procedures can create unexpected challenges. This is why facility fit should be evaluated very early and in considerable detail.
At Mabion, we have invested in a structured project management approach and give prospective partners the opportunity to virtually inspect our manufacturing areas. It allows technical teams to understand the actual facility, equipment and workflows before the project begins and makes subsequent discussions around technology transfer much more concrete.
Another common problem is the quality of the incoming development package. Insufficient process documentation, specifications that continue to change, incomplete analytical packages or unresolved scale-up questions can delay clinical material by months.
We also see projects lose momentum during the transition from preclinical development into the clinic. At that stage, the sponsor usually knows the molecule better than anyone else, but there are still fundamental uncertainties around clinical safety and efficacy. At the same time, the manufacturing process has to become increasingly robust and controlled.
That is exactly the point at which experienced external development expertise can add significant value. Bringing the right CDMO into the program earlier can help identify scale-up, analytical and manufacturability risks before they become critical-path problems later in development.
What shifts in customer priorities do you expect to dominate conversations at CPHI this year and what do they tell us about where the market is heading?
I am sure AI and digitalization will feature prominently in many conversations at CPHI. They are important developments, but from my perspective the most exciting discussions will be around advanced therapeutics and how the industry turns increasingly sophisticated science into manufacturable products.
We are seeing new modalities progress through clinical development and move closer to patients. As a result, the conversation is gradually moving from whether these technologies can work to how they can be developed, scaled, characterized and manufactured reliably.
This is highly relevant to Mabion. Our portfolio is no longer focused only on monoclonal antibodies and biosimilars. We are developing our capabilities and partnerships around innovative biologics, including antibody-drug conjugates, bispecific and multispecific antibodies, while continuing to build on our established expertise in complex proteins and monoclonal antibodies.
At CPHI Milan, we already have a number of discussions planned with existing and prospective partners around these areas. An important part of our message is also that globally relevant biologics programs can be successfully developed and manufactured in Central and Eastern Europe. The region combines a strong scientific base with a competitive operating environment and access to the European regulatory ecosystem.
For me personally, that is what makes this period particularly exciting. We are working with technologies that only a few years ago were considered highly experimental and are now moving closer to clinical and commercial reality. Ultimately, the purpose of all of this innovation is to bring better treatment options to patients.
What will distinguish the most successful development and manufacturing partners over the next few years?
The biopharma services market has changed significantly since the pandemic. During that period, very large amounts of capital entered biotechnology and manufacturing capacity expanded rapidly. New service providers emerged, while a number of biotechnology companies with proprietary pipelines also started offering development and manufacturing capabilities.
The market is now becoming more disciplined. Sponsors are more selective, financing is more constrained and development programs are under greater pressure to demonstrate both scientific and commercial potential.
I believe this environment will gradually change the role of the CDMO. The traditional model, in which a customer defines a scope of work and the CDMO simply executes it, will increasingly coexist with much deeper co-development relationships.
Partners that understand the science, contribute development expertise and are prepared to share responsibility for advancing an asset can create significantly more value than organizations that compete primarily on available capacity.
This thinking is already reflected in Mabion’s strategy. Alongside our core CDMO business, we are developing co-development models, expanding into areas such as ADCs and other innovative biologics, and exploring opportunities where intellectual property and development value can be created jointly with partners. The reactivation of the MabionCD20 program, including its development strategy in orphan indications, is another example of how we are combining our manufacturing and development expertise with a more asset-focused approach.
Rare diseases are particularly interesting in this context. Regulatory frameworks such as orphan designation in the United States and European Union have created mechanisms that can make development in smaller patient populations more attractive and feasible.
Over the next few years, I therefore expect the strongest development and manufacturing partners to be distinguished not simply by the number of bioreactors they operate, but by the quality of their scientific teams, their ability to solve development problems, their flexibility and their willingness to remain committed to a molecule throughout its lifecycle. The future of the industry will be increasingly partnership-driven rather than purely transactional.
