The Rise of the Multi-Modality CDMO: Why Clients Need More Than Capacity

Key Takeaways

• Pharma and biopharma companies increasingly need CDMO partners that offer more than available capacity, including regulatory credibility, cost competitiveness, execution discipline, transparent communication, and resilient supply.

• Multi-modality CDMO models create considerable additional value when expertise in biologics, drug–device combinations, complex sterile injectables, and specialized oral dosage capabilities are connected through shared quality systems, project governance, and cross-modality learning.

• Fragmented outsourcing models can create handoff risk, with knowledge, time, accountability, and cost control lost as programs move among separate drug substance, drug product, device, logistics, and release partners.

• Cross-modality experience can strengthen development and commercialization, as learnings from GLP-1 device programs, sterile drug product, packaging, and quality release can inform other small molecule and biologics programs.

• OneSource’s integrated innovation model is designed to connect modality breadth with regulatory status, shared quality systems, technical know-how, flexible business models, and reliable execution from development through commercial supply.

For pharma and biopharma companies developing biologics, biosimilars, drug–device combination products, complex sterile injectables, and specialized oral dosage forms, capacity is no longer enough. The question is not only whether a contract development and manufacturing organization (CDMO) has an available line, suite, or manufacturing slot but whether it can convert that capacity into compliant, cost-effective, and reliable progress from development through commercialization.

Quality and regulatory status remain the top priority. Companies may compare CDMOs on price, timing, flexibility, and technical scope, but quality is not an area where they can afford compromise. A CDMO’s ability to support products for highly regulated markets depends on the strength of its quality systems, its inspection history, and its ability to meet expectations from stringent regulatory authorities for drug substance, drug product, and, where relevant, device-related work.

Cost remains important, particularly in biologics and biosimilars, where biopharma companies face intense pressure to reduce cost of goods while maintaining product quality and supply reliability. For biosimilar developers planning launches years in advance, even modest differences in production efficiency, yield, or commercial terms can affect long-term competitiveness. However, cost cannot be evaluated separately from execution. A lower-cost manufacturing path offers little value if the program encounters avoidable delays, regulatory uncertainty, repeated work, or unreliable supply.

Execution is therefore central to modern CDMO selection. Complex scientific programs rarely proceed without technical, operational, or scheduling challenges. Clients understand that unexpected issues may arise, but they increasingly expect their CDMO partners to identify problems quickly, communicate transparently, and implement solutions through established systems and processes. The measure of a strong partner is not a promise that nothing will go wrong; it is the ability to respond effectively when challenges emerge.

Continuous supply adds another layer of complexity. After development work is completed, data are generated, and regulatory filings are submitted, the client still needs dependable commercial supply. That requirement becomes more demanding when products must serve multiple markets with different expectations around release, distribution, and supply planning. In Europe, for instance, pharma and biopharma companies may need to account for multiple national markets, batch segmentation, and release requirements, adding complexity beyond the manufacturing process itself. CDMOs that can manage those practical realities while maintaining quality, cost control, and communication discipline will be better positioned to support clients over the full product life cycle.

The shift toward more complex products is changing how clients think about fragmentation. In a traditional outsourcing model, a pharma or biopharma company may work with one partner for drug substance, another for drug product, another for device or delivery-system work, another for logistics, and additional laboratories or regional release partners for testing and market supply. Each partner may perform its assigned work well, but the program as a whole can still lose time, knowledge, and accountability at the interfaces.

Those handoffs matter. Process assumptions may not transfer cleanly from drug substance to drug product. Device, packaging, and release requirements may be addressed after critical development decisions have already been made. Logistics and market-release planning may sit outside the main technical program. The pharma company then becomes the integrator, responsible for reconciling timelines, data packages, quality expectations, and accountability across multiple vendors.

This is where the idea of a multi-modality CDMO can become meaningful, but only if the model is truly integrated. A company with several unrelated capabilities under one corporate name does not necessarily reduce complexity for the client. The value comes when those capabilities are connected through common operating principles, shared quality oversight, scientific learning, project management, and commercial execution. In that model, breadth is not simply a larger menu of services; it becomes a way to preserve program knowledge and reduce friction as products move across development and manufacturing stages.

At OneSource, our goal is integrated innovation. The idea is to go beyond end-to-end service in a narrow sense and create a model in which large molecule and small molecule programs can be supported across both product and service needs. For a client, that can mean fewer separate handoffs, clearer ownership, and a more coordinated path across drug substance, drug product, device-related work, packaging, logistics, testing, release, and market supply.

OneSource Specialty Pharma was created by bringing together several differentiated CDMO capabilities. Its foundation includes Stelis Biopharma’s biologics drug substance, drug product, and device capabilities; drug–device combination expertise; Steriscience’s complex sterile injectable portfolio; and Strides Pharma Science’s soft gelatin capsule business. Together, those capabilities give OneSource a platform spanning biologics, drug–device combinations, complex sterile injectables, and soft gelatin capsules.

For biologics, OneSource supports drug substance, drug product, and device-related development and manufacturing. For drug–device combination products, the company supports small molecules and peptides that are converted into sterile formats and assembled into delivery systems. For complex sterile injectables, customer-supplied active pharmaceutical ingredients can be developed and manufactured as sterile drug products, packaged, and supplied for commercialization. For soft gelatin capsules, OneSource similarly receives customer active ingredients and converts them into finished softgel products for commercial use.

This breadth matters because drug developers increasingly need partners that can support different product types and presentations without treating each modality as an isolated business. However, multi-modality should not be understood as the same approach applied to every product. Biologics, complex injectables, drug–device combinations, and softgels each bring different scientific, technical, regulatory, and operational requirements. A credible multi-modality CDMO must therefore combine consistency in quality and execution with modality-specific expertise that respects the differences among product types.

Successful multi-modality CDMOs must combine operational consistency and execution excellence with deep, modality-specific expertise. At OneSource, this principle is central to shaping our operating model. The goal is not to force every program into one template but to give clients access to a connected platform that can adapt to the product’s requirements. For some programs, the primary value may be speed, standardization, and cost efficiency. For others, the value may lie in product-specific development strategy, device integration, regulatory planning, or flexible commercial terms. In each case, capacity becomes more valuable when it is paired with scientific judgment, operational structure, and execution discipline.

A multi-modality model is strongest when experience in one area can improve performance in another. That is especially important in areas where different product types share downstream requirements. Biologics, drug–device combination products, and complex sterile injectables may differ in molecule type and development pathway, but they can share common disciplines in drug product handling, device integration, packaging, and quality release.

OneSource’s experience with GLP-1 analogs illustrates that principle. Work with GLP-1 products in pen and autoinjector formats has generated experience in sterile drug product, device manufacturing, packaging, regulatory support, and global commercialization. Those learnings can inform other injectable programs because many downstream considerations remain relevant even when the molecule changes. The product placed into the device may be a small molecule, peptide, or biologic, but the science and execution discipline around drug product, device, packaging, and release can overlap.

This kind of cross-modality learning helps convert breadth into practical value. If learning remains trapped within a single site or product category, the client receives only the benefit of that individual project team’s experience. If learning is captured through quality systems, operating procedures, and corporate-level oversight, it can be applied more broadly across programs. That creates a feedback loop in which experience from one modality informs execution in another, supporting better decisions, faster troubleshooting, and more confident program planning.

A unified quality framework is essential to that process. Multi-modality operations require enough consistency to promote quality, data integrity, documentation discipline, and inspection readiness across the organization, while still allowing site- and modality-specific procedures to account for different technologies and product risks. Biologics may require deeper scientific controls than some softgel programs; sterile injectables may require different process and sterility assurance considerations; drug–device combinations may add device, packaging, and usability dimensions. The strategic value lies in maintaining a common quality culture while allowing each modality to retain the technical practices it needs.

Quality systems must also evolve as experience accumulates. As OneSource executes programs, operational learnings can be incorporated into standard operating procedures and guiding documents. That matters because the value of a CDMO is not only in what it has done before but in how effectively it captures and applies what it has learned. In a multi-modality environment, continuous improvement should not occur only within one segment; where learnings are applicable, they should move across the platform.

OneSource’s biologics strategy highlights another important principle for multi-modality CDMOs: clients need both standardization and flexibility. Not every product benefits from the same development model. Biosimilars, new biologic entities, and animal health products may all sit within the broader biologics category, but they create different demands for cost, speed, scientific customization, and regulatory alignment.

For biosimilars, standardization can be a major advantage. Platform-based approaches can help optimize cost, effort, and timelines. In a category where every day lost can affect the client’s commercial opportunity, efficient templates and established processes can make a meaningful difference. Biosimilar developers need cost-effective execution, predictable development pathways, and disciplined manufacturing support that can help them compete in a price-sensitive market.

New biologic entities often require a different approach. Timelines still matter, particularly for gene-to-IND (Investigational New Drug) goals, but the product-specific scientific work may be less amenable to a rigid platform. Each molecule may require its own process development strategy, data package, and chemistry, manufacturing, and controls (CMC) plan. In these programs, a CDMO’s value lies not only in speed but in helping the client develop a regulatory-ready strategy that reduces the chance of repeating work later.

The distinction is important. A CDMO that relies only on standardization may struggle with novel or specialized products. A CDMO that treats every program as fully bespoke may struggle to deliver the efficiency needed for biosimilars and other cost-sensitive categories. Pharma and biopharma companies need a partner that can determine where standardization adds value and where customization is necessary. Multi-modality capability should therefore be paired with development judgment: the ability to choose the right operating model for the product, the client, and the commercial goal.

Execution is where the promise of a CDMO model is tested. Drug developers do not select a partner only for what appears in a capabilities presentation; they select a partner to execute under real conditions, including technical uncertainty, changing timelines, regulatory requirements, market pressure, and supply expectations. In that environment, systems, communication, and flexibility can become as important as physical capacity.

Agility is one point of differentiation. Clients value rapid access to the right people, timely proposal and contract discussions, and responsiveness throughout the project life cycle. That need does not end once the project is awarded. As programs move forward, they need access to project management, technical, quality, and business teams that can keep information flowing, especially when challenges arise.

Transparent communication is particularly important for a CDMO operating from India while serving clients in the United States and Europe. Geographic distance and time-zone differences can create practical barriers if not actively managed. OneSource addresses that challenge through project teams structured to support client time zones and provide near-real-time updates on project progress or setbacks. The goal is not only to communicate frequently but to maintain confidence that the client is receiving timely, accurate information from a partner that understands the urgency of the program.

Flexibility also matters because clients are not all the same. Large pharmaceutical companies may have greater risk appetite, deeper internal resources, and more established development infrastructures. Emerging companies may be advancing promising molecules with staged capital, tighter budgets, and less room for large upfront investments. A CDMO that can adapt business models to different client realities can help keep promising programs moving while still protecting technical and commercial discipline.

That flexibility should not be confused with a lack of rigor. The strongest CDMO partnerships combine adaptability with structure. They recognize that every program will have constraints, but they also maintain the systems and processes needed to identify risks, respond to issues, document decisions, and protect quality. For pharma and biopharma companies, the practical question is not whether a CDMO can say yes to a request; it is whether the partner can help shape a feasible path forward.

OneSource’s integrated innovation model is designed to translate modality breadth into coordinated execution. Rather than treating biologics, drug–device combination products, complex sterile injectables, and soft gelatin capsules as separate offerings, the company connects those capabilities through quality systems, technical expertise, project coordination, and commercial supply planning.

That connected model is particularly important when programs require support across multiple development and manufacturing interfaces. OneSource can help clients align drug substance, drug product, device-related work, packaging, release activities, and supply considerations within a more unified framework, reducing the need to coordinate multiple disconnected vendors as products move toward clinical or commercial readiness.

The company continues to invest across that platform, with biologics remaining a major strategic focus alongside continued investment in drug–device combination products, recent expansion in soft gelatin capsules, and ongoing upgrades to sterile injectable production lines. Those investments are intended to support clients across product types while maintaining the technical know-how, quality expectations, cost competitiveness, and execution discipline each modality requires.

OneSource also emphasizes scientific and technical contribution, not only manufacturing availability. Its platform includes technologies intended to improve yield and support more cost-competitive production, as well as capabilities that can help clients differentiate products through delivery format, process efficiency, or commercial readiness. The same flexibility extends to partnership models: emerging companies may need staged investment and creative commercial structures, while larger companies may prioritize scale, reliability, regulatory credibility, and global supply execution.

OneSource’s facility strategy reflects the same emphasis on quality and future readiness. During early planning for its biologics and drug–device combination operations, the company sought U.S. Food and Drug Administration (FDA) input on facility plans, layouts, and technology approach. That engagement helped reinforce the value of single-use systems, which OneSource uses in mammalian drug substance production and drug product fill-finish operations. The larger point is that the company’s facilities, systems, and processes were designed around global expectations rather than added only after commercial opportunities emerged.

As pharmaceutical products grow more complex and globally interconnected, competitive differentiation in the CDMO sector will continue to move beyond manufacturing capacity alone. Pharma and biopharma companies will still need scale, but they will also need partners that can integrate diverse modalities, retain knowledge across the development life cycle, communicate transparently when challenges arise, and translate scientific and operational complexity into more consistent, predictable progress.

That is the promise of a true multi-modality CDMO: not simply more services under one name but a more connected way to move complex products forward from early concept through commercial supply. For companies developing biologics, biosimilars, drug–device combinations, complex sterile injectables, and specialized oral products, the strongest partner is not necessarily the one with the longest list of capabilities. It is the one that can translate those capabilities into quality, execution, continuity, and commercial confidence.