Do you expect continued movement away from one-stop-shop outsourcing toward deeper modality-specific expertise?

I don’t think we’re seeing a broad movement away from one-stop-shop outsourcing. What we are seeing is more deliberate partner selection.

As CMC programs become more complex, companies are still looking to reduce fragmentation, particularly as they move across development stages and into commercial manufacturing. That continues to keep interest in integrated partners high, where continuity, accountability, and fewer handoffs can directly accelerate and de-risk timelines and execution to provide developers more certainty.

At the same time, the bar for technical depth has increased. New complex modalities require specialized expertise at each stage of development.

In practice, this isn’t a shift away from integrated models. It’s an evolution of expectations. Companies are looking for partners that can bring both: deep technical expertise and the ability to scale and accelerate forward without introducing new friction or risk.

The diversity of therapeutic modalities in clinical development across the globe makes a one-stop shop for biologics end-to-end outsourcing very challenging. The potential benefits of a single supplier resonate across an organization both in hard and soft savings, but the reality is, skill sets between discovery, manufacturing, and safety and release support differ widely. Even with a focus on release testing, the variability in safety testing versus analytical testing requires a broad infrastructure to support.

Contract laboratories with robust platform methods, like Charles River, offer a key advantage to early-stage sponsors. Where the therapeutic shares critical quality attributes (CQAs) across modalities, the one-stop-shop paradigm can almost be a reality for early-phase targets. As therapeutic modalities become more divergent, including peptide, oligo, and unique conjugates therein, as well as advances in cell and gene therapies, the need for specialized analytics becomes more pressing. The specialized analytics will limit the on-stop-shop until the divergent markets become more aligned on how to measure the CQAs.

Not necessarily. The answer depends heavily on the stage of the company and the maturity of its program. Earlier stage companies with less developed programs will need specialist CDMO support to navigate phase I and phase II, particularly when their manufacturing process demands deep technical expertise.

However, as a program advances toward phase III and commercial manufacturing, the calculus shifts. Generalist CDMOs bring a heavy lift of regulatory, quality and clinical support that specialist CDMOs simply cannot match. At that point, a common strategy is to leverage specialist expertise early, then transfer knowledge to a one-stop-shop CDMO capable of handling commercial manufacturing and product release.

The nuance is in the transition. A specialist CDMO has real utility, but only up to a point in the company life cycle. Unless a therapy requires a capability that virtually no one else in the world can provide, the trend is toward operational standardization and uniformity at scale.

So rather than a wholesale shift in one direction, the market is seeing a staged approach: specialist first, generalist later, with the developer's strategy, opportunity size, and supply chain goals dictating the timing.

For advanced therapeutics, such as cell therapy, CTMC expects continued movement toward deeper modality-specific expertise rather than broad “one-stop-shop” outsourcing models. While large integrated providers offer procurement simplicity and broad infrastructure, the complexity of advanced therapies increasingly requires highly specialized technical and operational capabilities.

Many biopharma companies already organize outsourcing by modality because the scientific, manufacturing, regulatory, and clinical requirements for cell therapies differ significantly from those of traditional biologics. For advanced therapeutics, success depends less on the breadth of services offered and more on deep expertise across process development, analytics, manufacturing, regulatory strategy, supply chain coordination, and clinical implementation.

Cell therapy development is especially interconnected, where manufacturing decisions can directly affect product quality, scalability, and clinical outcomes. Sponsors therefore increasingly value partners with focused experience navigating challenges, such as complex starting materials, vein-to-vein logistics, rapid manufacturing timelines, and evolving regulatory expectations.

At CTMC, we believe the future competitive advantage for CDMOs will come from building specialized translational ecosystems that integrate technical expertise, operational execution, and clinical proximity within a specific therapeutic domain to accelerate development, reduce risk, and help innovative therapies reach patients faster.

The train has left the station, and sponsors are the ones driving the shift, not CDMOs. As complexity continues to increase, sponsors are looking for partners who can help absorb that risk through expertise. We’re seeing a trend of more focused companies that have capitalized on their specialization, backed by exceptional equipment and talent. As the winds of the market change, so will the strategies and positioning of the CDMOs who serve them. Instead of adding capabilities, expect to see deeper specialization rather than trying to do everything under one roof. That said, it’s a balancing act; you want the expert who can dive deeply into challenging problems, but also be capable of seeing the big picture on how their solutions impact drug development as a whole. That’s where cross-disciplinary backgrounds make all the difference.

There is a clear and ongoing shift away from the traditional “one stop shop” model toward deeper modality-specific expertise, although this is best understood as an evolution rather than a complete departure from integration. As pipelines become more complex, sponsors increasingly prioritize partners with demonstrable depth in specific modalities, supported by infrastructure, equipment, analytical capability, and regulatory experience tailored to those technologies.

This is also reflected in targeted investment strategies across the CDMO landscape, where organisations are selectively expanding capabilities to support emerging modalities and associated supply chain requirements — for example, through focused developments in areas such as packaging of advanced therapeutic medicinal products (ATMP) in ultra-low temperature (ULT) conditions to meet the growing needs of increasingly complex and temperature-sensitive products.

At the same time, fragmentation across too many niche providers can introduce development risk, particularly at modality interfaces or during scale-up and transition points. As a result, CDMOs that can combine focused scientific specialization with integrated development, analytical, and supply capabilities are particularly well positioned.

Rather than offering every capability in house, differentiation is increasingly based on clarity of focus, technical credibility, and quality-led execution, alongside the ability to collaborate effectively across functions and partners. In this model, integration remains important — but it serves to support informed decision making, risk management, and long-term manufacturability, rather than positioning breadth alone as the primary differentiator.

Yes — and I don’t see this as a short term swing so much as a structural shift in how sponsors think about outsourcing. The industry is undoubtedly moving away from a pure “one stop shop” model toward partnering with organizations that offer deep, modality specific expertise, particularly as pipelines become more complex and less forgiving of generic solutions.

While breadth still has value, what we’re hearing consistently from sponsors is that depth now matters more. As programs advance into highly potent active pharmaceutical ingredients (HPAPIs), antibody–drug conjugates (ADCs), targeted radiopharmaceuticals, peptides, oligonucleotides, and increasingly complex small molecules, the risk profile changes. Development decisions need to be made earlier, based on high quality data, robust analytical insight, and a clear understanding of how a molecule will behave at scale and under regulatory scrutiny. That’s not something that can be delivered effectively without genuine technical specialism.

At Almac Sciences, our strength lies in that intersection of scientific depth and development pragmatism. We’ve deliberately invested in modality relevant expertise — from advanced analytical platforms, such as NMR and mass spectrometry, to radiochemistry, biocatalysis, and flow chemistry — so that we can solve difficult problems, not just execute predefined tasks. Importantly, this expertise is embedded across development, scale up, and GMP manufacture, enabling continuity of scientific thinking rather than hand offs between disconnected teams.

I don’t believe this trend eliminates the need for integrated outsourcing; rather, it reframes it. Sponsors increasingly want integration built on depth; partners who understand the nuance of a specific modality and can apply that understanding across the life cycle. Those organizations that combine modality specific excellence with strong project governance and regulatory awareness will be best placed to support the next generation of therapies.

As the number of novel therapies increases and their technical complexity continues to grow, the need for the right CDMO support, both across the supply chain and at each stage of product development, has become increasingly critical.

In response, originators are reassessing the traditional “one-stop-shop” CDMO model, in some cases favoring multiple highly specialized partners for critical activities.

While integrated platform models remain attractive in early development — offering simplified supply chain management and streamlined execution — this dynamic often evolves as programs advance. At later clinical stages and through to commercialization, the benefits of engaging established specialists become more pronounced, particularly in areas such as process optimization, scale-up robustness, and regulatory confidence.

Adopting a multi-specialist supplier model at late-stage development and commercial scale can provide advantages in optimizing long-term commercial operations, while also enhancing supply chain resilience by reducing dependency on a single vendor across all aspects of product delivery.

Codis performs strongly within this evolving landscape, combining a proven track record in spray drying scale-up and commercialization with a flexible, collaborative approach. This enables effective integration with partner CDMOs, supporting technical success and maximizing overall program value throughout the broader development pathway.

The shift is real, and I expect it to continue, but the story is more interesting than a simple move away from generalists.

What's driving it is modality complexity outpacing what any single partner can credibly cover. When sponsors are developing cell therapies, RNA medicines, or genomic therapeutics, they're operating in entirely different scientific and operational disciplines. Understanding transcriptome profiling and digital pathology aren't just different skills; they require entirely different scientific languages, tooling, and ways of thinking. The best sponsors have recognized this and are building curated partner ecosystems rather than defaulting to whoever offers the broadest menu.

That said, integrated outsourcing isn't simply failing. For programs where operational scale and coordination simplicity matter more than cutting-edge modality expertise, the generalists still have a strong value proposition. The real question is whether their acquisitions and centers of excellence can genuinely transfer deep expertise, or whether they're acquiring assets without absorbing the knowledge that makes those assets valuable.

My expectation is a durable two-tier ecosystem: specialized partners winning on scientific credibility for complex modalities, and integrated partners winning on scale and simplicity where that's what sponsors actually need.

As therapeutic pipelines diversify, the manufacturing needs of each modality are becoming more distinct. A single facility or “universal” production line simply cannot accommodate the full spectrum of requirements across biologics, highly potent small molecules, advanced modalities, and emerging formats. Even with modern flexible equipment, many products still demand specialized containment, dedicated technologies, or unique process controls.

Rather than trying to cover every modality under one roof, many CDMOs are choosing to specialize in the areas where they can deliver the highest reliability and the strongest regulatory track record. This allows them to maintain high utilization while offering sponsors the depth of expertise needed to navigate increasingly complex manufacturing landscapes.

Sponsors, in turn, are prioritizing partners who can demonstrate expertise in a modality, not just general capability. They want confidence that a partner understands the nuances of their molecule, can support both early stage agility and commercial scale robustness, and has the right infrastructure within the right market in place.

As a result, the outsourcing model is evolving from broad one stop shops to a more localized interconnected network of specialized, high performance partners. This trend will continue as modalities grow more sophisticated and manufacturing demands become more differentiated.

As drug developers advance complex genomic medicines to the clinic, we are seeing the industry shifting away from generalized one-stop-shop outsourcing in favor of deep, modality-specific expertise. When treating rare and orphan diseases, developers must prioritize ultimate safety, purity, and clinical efficacy over mere operational convenience. At 4basebio, we are seeing this trend with sourcing of DNA templates, where legacy bacterial plasmid manufacturing introduces significant clinical risks, including unwanted bacterial backbones, antibiotic resistance genes, and fermentation impurities. Consequently, the market is aggressively demanding cell-free, synthetic DNA alternatives that eliminate these legacy bottlenecks and deliver the uncompromising safety profile next-generation therapies require.

The challenge, then, is to bridge this gap and give developers access to better clinical materials without adding procurement complexity so that choosing the safer option doesn't mean taking on more operational burden.

This is why I don’t see the move toward modality-specific expertise slowing down. In the next generation of genomic medicines, raw materials can no longer be treated as transactional line items, they are part of the therapeutic risk profile. DNA templates are one clear example of where deep expertise matters, but the broader point is that complex modalities demand partners who understand the risks at their source. The companies that recognize this now will be better positioned to move complex medicines into the clinic with greater confidence, while those that continue to rely on legacy manufacturing models may find convenience comes at a much higher cost.

While there are certainly contractual, vendor management, and sometimes logistical advantages to working with a generalist CDMO, for advanced therapeutics, I see a strong gravitation toward modality-specific expertise.

The one-stop-shop model may have made more sense in the early days of cell therapy maturation, when sponsors were navigating unfamiliar territory and, in many cases, turned to a CDMO with which they had an existing relationship to get efforts off the ground. But the programs maturing through the pipeline now are sophisticated, and innovator teams truly need a CDMO partner with in-depth, specialized expertise and extensive experience solving a wide range of challenges.

Within the biopharmaceutical industry, the diversity of cell types and applications perfectly illustrates the need for specialization. CAR-T, CAR-M, CAR-NK, TCR-T, differentiated iPSC-derived products, T_reg cells, and other cell types each have distinct characteristics and require customized manufacturing processes and advanced analytical capabilities to deliver the quality and consistency that patients deserve, and regulators demand. Additionally, autologous programs run on patient-specific timelines and release testing constraints that are simply incompatible with the operational tempo of a facility optimized for large-scale biologics. Allogeneic programs bring different pressures, including donor screening, lot-to-lot consistency, and comparability across batches.

We consistently hear from clients in late-phase development that they need a CDMO partner whose infrastructure was purpose-built for cell therapy manufacturing.

I expect the trend toward modality-specific expertise to continue and probably sharpen. As more programs reach the pivotal stage, sponsors will have less tolerance for CDMOs that are still building the capabilities they need while the clock is running. The CDMOs that will lead the cell therapy industry five years from now are the ones making deliberate, focused bets today.

The ease of a one-stop shop remains appealing to clients seeking to expand their resources. However, for emerging modalities like multispecifics and bioconjugates, expertise and track record are increasingly valued — particularly for ADCs, where experience with specific conjugation technologies is sought after.

That said, when two CDMOs offer comparable specialized expertise, clients tend to favor the one-stop shop. The decision ultimately comes down to risk tolerance. Seamless project management — including a dedicated point of contact, transparent reporting, defined milestones, proactive issue resolution, and regular status updates — means clients may need to devote fewer internal resources to oversight, making it a more attractive risk mitigation option. A proven track record further reduces that oversight burden and instills greater confidence in the partnership, becoming a key differentiator when technical capabilities are comparable.

As with traditional therapeutic modalities, expertise and quality remain the most important considerations overall. While specialization in an advanced modality is valuable, it does not alone ensure an ideal partnership — other factors, such as manufacturing capacity, organizational culture, timelines, and alignment of goals, must also be weighed in the final sourcing decision to best mitigate risk and foster a successful, long-term collaboration.

By May 2026, the U.S. FDA had already cleared five drugs representing entirely new therapeutic classes. These are not refinements of existing treatments but genuine breakthroughs that address biological targets long considered out of reach. Historically, only two to three first-in-class drugs are approved each year — so reaching (and potentially exceeding) that mark before mid-year underscores an exceptional pace of innovation. This clearly reinforces the fact that drug product pipelines are being reshaped at a fundamental level — an enduring trend rather than a temporary shift.

CDMOs need to adapt to this transformation by transitioning from a “one stop shop” model to a more agile framework, where deep, modality driven expertise is critical to success.

This shift requires fundamental redesigning of both operating models and organizational structures. The core challenge lies in transitioning from internal, generalist expertise to a dynamic ecosystem of specialized partners, able to bring highly agile and targeted solutions to each challenge. At Gattefossé, our ambition is to be an integral part of this innovation ecosystem, alongside CDMOs, by delivering high-value expertise in lipid-based formulation technologies.

I’m seeing the conversation shift from whether to select a specialized CDMO to how deep CDMO specialization actually needs to be.

For years, the large one-stop-shop CDMOs held an obvious appeal. You could hand off a program and, in theory, never have to coordinate across vendors. But what that model quietly traded away was depth of expertise. A CDMO offering capabilities across small molecules, biologics, gene therapy, cell therapy, and other areas likely does not have extensive expertise in any one discipline, particularly in advanced therapeutic mechanisms.

Being a generalist works and is arguably an advantage for straightforward programs. However, focused expertise is needed for complex and emerging science.

Drug delivery, for example, has become much more sophisticated. Lipid nanoparticle (LNP) formulation, polymeric nanoparticles, and microspheres for long-acting injectables aren’t problems you solve by applying general pharmaceutical manufacturing logic. Risks and common failure points are specific to each drug delivery platform. You can't troubleshoot complex issues without having seen them before across many programs.

What I increasingly hear from clients is that they took the one-stop-shop route early in their program and lost 12 to 18 months because their vendor couldn't solve their drug delivery challenge, so they come to Phosphorex. We've been solely focused on particle-based drug delivery solutions for over 20 years. Clients are increasingly rewarding us for our expertise and institutional knowledge. This trend will continue as sponsors get ever more sophisticated when selecting CDMO partners.

Rather than waiting for the answer to that question, Alloy’s Genetic Medicines business unit is both licensing AntiClastic™ Cyclic Oligonucleotide antisense technology and offering CRO-style services for RNA medicines. Because of this, we have no choice other than to be one-stop RNA medicines outsourcing shop with deep capabilities and experience built around oligonucleotide medicines. We partner our next-generation AntiClastic technology with large pharma and biotechs, emerging biotechs, and academic institutions to give their antisense oligonucleotide (ASO) targets a potency boost and IP protection while also accelerating their drug discovery and preclinical development with our lab capabilities.

Oligonucleotide-based medicines have recently come into their own as a drug modality with 21 FDA approvals and counting. Despite the success of the category, there would likely be many more approvals with higher potency and lower inflammatory molecules. Alloy is solving those problems with our AntiClastic technology that consistently outperforms gapmers at RNase H-mediated decay and other mechanisms of action.

The cyclic AntiClastic structure feature inverted nucleotides at one end of the molecule, which base pair through Watson–Crick interactions to form a conformationally constrained, transiently circular structures. That overlap region shields both termini during delivery and cellular uptake from degradation. Further, our molecules often feature two 3’ ends, which reduces the exposure to pro-inflammatory receptors, which reduces undesirable immune responses.

We also use our fully integrated, onsite drug discovery capabilities, including oligo synthesis and QC, antibody–oligonucleotide conjugations, in vitro screening, and preclinical testing to provide both end-to-end and ad hoc services. Regardless of whether our clients are interested in our AntiClastic technology, they can trust that when it comes to getting their programs to development candidates, we are an outstanding scientific and technical partner that knows how to deliver.

RNA medicines are not a generalist discipline. The chemistry, delivery biology, and regulatory considerations are specific enough that broad-platform CROs and CDMOs struggle to keep pace with what the field now demands. Sponsors increasingly recognize that a partner with concentrated expertise in a single modality will get them further, faster, than outsourcing partners spread thin across many therapeutic areas.

As formulations, manufacturing processes, and regulatory requirements become more specialized, the conversation around specialization makes sense. Modality complexity is real, and deep expertise matters. But in our experience working with biopharmaceutical developers on custom buffers, reagents, and media, specialization alone has never been the whole story. What customers actually need is technical depth paired with the kind of flexibility and responsiveness that keeps their programs moving.

A team moving from clinical to commercial scale needs more than technical knowledge of sterile filtration or complex formulations. They need a partner who picks up the phone when specs change, who can pivot without a months-long process, and who works closely enough with their team that you'd hardly know where one organization ends and the other begins.

We've found that specialization builds the foundation of trust, but it's the day-to-day responsiveness and the quality of the relationship that ultimately determine whether a partnership accelerates a program or creates friction. The companies that stand out aren't simply the ones with the deepest technical focus; they're the ones who've learned to combine that expertise with genuine customer intimacy and the operational fluency to keep complex workflows on track. In short, expertise is important, but customization is critical, and responsiveness is what makes it all work.

From an Experic perspective, I think more in terms of capabilities rather than modalities. But the idea and my thoughts remain the same. The one-stop-shop model made sense when pharmaceutical companies were outsourcing largely for cost containment.

Innovators consolidated vendors, reduced procurement overhead, and handed a single partner as much of the value chain as possible. The reality was that, as Big Pharma began divesting its manufacturing facilities in the early 2000s, contract manufacturing organizations were commonly formed by operating the same facility, running the same lines, and producing the same drug products their clients had.

However, what I am seeing now, and what I expect to continue, are sponsors distinguishing between capabilities that require true depth and those that don't. For commodity manufacturing, the generalist CDMO still works fine. But for complex processes like dry powder inhalation (DPI), spray-dried dispersions, highly potent APIs, and complex encapsulation, the technical bar is much higher.

Many of today’s programs are sophisticated, and innovators need a CDMO partner with in-depth, specialized expertise, and extensive experience solving challenges specific to their drug product. In practice, that means sponsors are more willing to manage two or three specialized partners than they were five to 10 years ago. It's more work for them administratively, but the risk-adjusted outcome is better.

The Experic team has experienced this directly, so we're not trying to be everything to everyone. We have deep mastery of complex powder handling, DPI, and spray drying, all technically demanding processes where proficiency determines whether a program succeeds. This positioning has become more attractive to sponsors, not less, as capacity in these areas tightens.

The companies that built broad but shallow capability portfolios will face pressure as sponsors develop increasingly complex therapeutics, which require specific technical know-how.

Large CDMOs may advertise broad, end-to-end offerings, but in practice very few sponsors use more than a small fraction of those services. It is extremely difficult for any single organization to align capacity, expertise, geography, timelines, and technical depth across an entire portfolio of diverse products. The result is a model that looks comprehensive on paper but delivers limited integrated value in practice.

However, what is working, and becoming more common, is a focused one-stop model built around a single molecule, modality, or technology platform. Sponsors benefit when they partner with CDMOs that bring deep technical expertise, established infrastructure, faster decision-making, fewer tech transfers, streamlined contracting, and reduced operational risk. As modalities become more complex and demand specialized analytical methods, development strategies, and regulatory fluency, this depth becomes essential.

We already see this dynamic in small molecule API development and manufacturing, where specialized chemistry, analytical capabilities, scale-up experience, and regulatory understanding are essential. As modalities become more complex, sponsors will increasingly prioritize CDMOs with modality-specific platforms, scientific know-how, and integrated teams capable of supporting programs from early development through scale-up and manufacturing.

When dealing with the intense complexities of cell and gene therapies, a standard generalist approach often falls short during critical scale-up phases. However, sponsors aren't looking for single-modality silos, either. Over the course of my 22 years in strategic operations, I've found that the most successful outcomes are driven by partners who can offer deep, specialized technical depth across a comprehensive, multi-modality ecosystem. Sponsors are increasingly seeking organizations that can seamlessly support various advanced therapies under unified, rigorous quality systems. It requires significant operational grit to master the nuances of tech transfer and manufacturing for different modalities simultaneously. Building that targeted expertise across a versatile portfolio without compromising on depth is what ultimately accelerates lifesaving therapies to the market.

After 25+ years split almost evenly between a “one-stop-shop” CRO and small specialty CROs, I've watched the outsourcing model swing back and forth and back again. My view has always been that there is no one-size-fits-all answer, even within a single sponsor portfolio. I do expect to see continued movement toward specialty expertise, but not a wholesale shift. Ultimately, it depends on what the program needs.

Both models are useful because they solve different problems. For large, standardized programs, the full-service shop wins on breadth and cost. It's a different story for complex, differentiated assets where the endpoints are non-standard; the regulatory precedent thin, or the investigator pool is so small or specialized that knowing them personally matters. There, being a generalist works against you. The specialist isn’t trying to do everything, but they handle the pieces a generalist can't de-risk.

The real shift needs to move toward fit-for-purpose solutions, matching the model to the asset. That is the conversation we have with our clients. A one-stop-shop is the right answer sometimes, and the wrong one just as often. The edge goes to teams that can tell the difference early, before the model they picked shapes the trial more than the science does.

The era of the generalist CRO is winding down simply because the science has outgrown it. When you’re developing a complex cell therapy or an advanced ADC, traditional operational scale just isn't enough anymore. You can’t brute-force a trial with massive global infrastructure if you don't deeply understand the intricate regulatory hurdles or the hyper-specific patient populations required for these advanced modalities.

But let’s be honest: no sponsor wants the logistical nightmare of herding a dozen different boutique vendors. It’s a project management headache that slows down timelines.

Instead, the market is forcing a shift toward a hybrid model. Sponsors are looking for partners who offer the best of both worlds in the form of deep, specialized scientific expertise wrapped inside an established global engine. The CROs that win in this environment won't just be execution machines; they’ll be true scientific co-pilots. They need to intimately understand the exact behavior of a complex molecule, while still possessing the data infrastructure, geographic footprint, and operational continuity to carry that program seamlessly from early-phase trials, straight through to registration. Ultimately, it’s about solving for biological complexity without sacrificing global reach.

The CDMOs that will stand out are the ones that can build true partnerships, understand each partner’s specific needs, and adapt together as new modalities evolve.

For pharma companies, this shift is as much practical as it is strategic. It takes time and effort to tech transfer complex processes, qualify new sites, and manage relationships across multiple CDMOs. That creates a significant operational burden, especially when companies are trying to move quickly or support multiple programs at once.

Spreading work across specialized CDMOs can help avoid overdependence on a single provider and give access to deeper technical capabilities where they matter most. The key is balance: companies want both risk mitigation and confidence that each chosen CDMO can reliably support the modality for which they are responsible for.

So, the likely future is a hybrid model. Pharma will continue to value specialized CDMOs, but only those that can collaborate closely, adapt with the science, and act as a true extension of their partners’ team.

The industry is shifting toward partnership models that require both modality-specific expertise and the ability to operate across multiple technical domains and scales. Integrated outsourcing models address this need by providing a seamless ecosystem that links from payload design, linker chemistry, biologics production, and conjugation, all based on robust scientific expertise and close coordination. This approach is particularly critical for manufacturing bioconjugates such as ADCs, which require expertise across development and manufacturing.

As the field progresses into novel bioconjugates with innovative payloads and dual-payload architectures, complexity increases and new analytical approaches, impurity control strategies, and downstream processing must be integrated. Fragmented outsourcing introduces unnecessary complexity and risk, while integrated models streamline workflows, reduce complexity, and improve overall efficiency. Phase-appropriate capabilities are equally important. Preclinical and early-phase development requires speed and flexibility to advance candidates quickly, while commercial manufacturing prioritizes reliability and consistent quality. Partners that can adapt their capabilities across stages provide a clear advantage by ensuring smooth transitions and sustained program success.

At Lonza, we connect every aspect of drug substance and drug product manufacturing through advanced development platforms and a global infrastructure that accelerates timelines, reduces tech transfer risks, and maintains consistent quality from early development through commercialization. This integrated approach delivers the flexibility and scalability needed as pipelines expand and modalities diversify, while also supporting the distinctive needs of each phase.

Ultimately, the most successful partnerships combine end-to-end capabilities with deep modality expertise and the agility to support each development phase, an increasingly critical requirement as conjugate therapies expand into new, complex disease areas, such as autoimmune, cardiovascular, and genetically driven diseases.

There is a shift, but, from my perspective, it is less modality-specific and more about expertise that helps resolve increasingly complex process development and manufacturing challenges. As therapies like biologics, long-acting injectables, and combination products evolve, they demand unique capabilities and higher quality standards. In these cases, broad approaches can’t keep pace so scaling for commercialization becomes challenging.

Much of the needed expertise relates to complex delivery methods. For example, higher-concentration formulations may improve patient convenience, but can they introduce challenges like high viscosity, stability issues, and more complex fill-finish processes. In particular, highly viscous formulations require specialized equipment, expert process and filtration knowledge, and robust quality systems to maintain consistency from development through commercial production.

As a result, I see pharma and biotech companies becoming more selective in choosing CDMO partners. They’re looking for teams with proven technical expertise and flexibility to address their unique needs. CDMOs with demonstrated experience solving complex formulation challenges, combined with a strong track record for quality and reliable execution, are increasingly valuable partners. Ultimately, specialized capabilities, operational agility, and consistent quality are what will set successful CDMO partners apart.

The reality is more complicated than a clear trend in one direction, because outsourcing strategies vary widely by company size, modality, and strategic priorities. Large biopharmaceutical organizations still see clear value in partners that can offer multiple capabilities and support programs over the long term. For these teams, breadth can enhance strategic alignment and reduce friction across development stages.

Emerging and mid‑sized biotechs, however, make decisions through a different lens. Their priority is speed, expertise, and the ability to reach the next milestone that unlocks funding. They are less concerned with whether a partner is formally “one‑stop” and more focused on whether that partner can deliver quickly, cost‑effectively, and with the right technical depth.The notion of a broad retreat from one‑stop models is not necessarily supported by industry behavior. Where shifts have occurred, they often reflect geopolitical dynamics rather than a strategic rejection of multimodality. What has changed, however, is the weight placed on innovative technologies and modality‑specific expertise, particularly in complex areas, where specialized knowledge of development, supply chain, and regulatory pathways is essential.