The Pros and Cons of Different CDMO Models

Copyright © DrugPatentWatch. Originally published at https://www.drugpatentwatch.com/blog/

In the high-stakes world of pharmaceutical development, the path from a promising molecule to a market-ready medicine is a labyrinth of scientific complexity, regulatory hurdles, and immense financial risk. For decades, the prevailing wisdom for many established players was to navigate this path in-house, building sprawling manufacturing facilities as monuments to their scale and control. Today, that paradigm has been irrevocably shattered. The modern biopharmaceutical landscape is defined not by monolithic, vertically integrated giants, but by a dynamic, interconnected ecosystem where strategic outsourcing is no longer a tactical cost-saving measure, but a fundamental pillar of corporate strategy.

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At the heart of this transformation is the Contract Development and Manufacturing Organization (CDMO). These entities have evolved far beyond their predecessors, the Contract Manufacturing Organizations (CMOs), from being mere “hired hands” for production to becoming integral strategic architects in the drug development journey. The decision to partner with a CDMO is now one of the most critical choices a pharmaceutical or biotech company can make. However, the most crucial—and often overlooked—decision is not just who to partner with, but how. The engagement model a company chooses—the very structure of the contract and the relationship—dictates everything from risk allocation and intellectual property rights to cost structures and the potential for innovation.

The sheer scale of this sector underscores its importance. The global CDMO market, a testament to this outsourcing megatrend, was valued at an astonishing $238.92 billion in . Projections show this figure soaring to $465.24 billion by , expanding at a compound annual growth rate (CAGR) of 9.0% . This explosive growth is fueled by a perfect storm of market forces: the increasing technical complexity of novel therapeutics like biologics and cell and gene therapies, relentless pressure to accelerate timelines in a competitive market, and the stark capital realities faced by the thousands of small, virtual, and emerging biotech firms that are now the primary engines of pharmaceutical innovation .

This report serves as a definitive guide for strategic decision-makers navigating this new era. We will dissect the pros and cons of the different CDMO models, moving beyond a simple checklist to provide a nuanced analysis of their operational mechanics, financial implications, and strategic suitability. The central thesis is this: choosing the right CDMO model is a strategic act that can create a durable competitive advantage, while choosing the wrong one can lead to costly delays, misaligned incentives, and jeopardized projects. Welcome to the CDMO crossroads—choosing your path wisely will define your future success.

Decoding the Outsourcing Ecosystem: CDMO vs. CMO vs. CRO

Before delving into the intricate world of engagement models, it’s essential to establish a clear and common vocabulary. The acronyms CRO, CMO, and CDMO are often used interchangeably, but they represent distinct functions within the pharmaceutical services landscape. Understanding these differences is the first step toward building a coherent outsourcing strategy.

• Contract Research Organization (CRO): A CRO is a service provider that supports the earlier, non-manufacturing stages of the drug development process. Think of them as the navigators of the complex clinical and regulatory journey. Their expertise lies in designing and managing clinical trials, gathering and analyzing data, and preparing the extensive documentation required for regulatory submissions to bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) . They are specialists in research, not production.
• Contract Manufacturing Organization (CMO): The CMO represents the traditional “hired hands” model of outsourcing. A pharmaceutical company engages a CMO when it has already developed a drug and simply needs a partner with the facilities and capacity to manufacture it, typically at a large, commercial scale . A CMO’s role is purely focused on production execution; they are not typically involved in the formulation or process development work that precedes it.
• Contract Development and Manufacturing Organization (CDMO): The CDMO is the integrated, modern evolution of the CMO. A CDMO provides comprehensive, end-to-end services that span the entire lifecycle of a drug, from initial development through to commercial production . Their services include critical development activities like pre-formulation, formulation development, process optimization, and analytical testing, seamlessly integrated with clinical trial material manufacturing and full-scale commercial manufacturing . This integration of “development” and “manufacturing” is their defining characteristic and core value proposition.

It is this integration that has enabled the rise of the modern virtual biotech. By outsourcing both the complex development work and the capital-intensive manufacturing, a small, innovation-focused company can advance a drug candidate from concept to clinic with a lean internal team, effectively de-risking the R&D pipeline.

However, the lines between these entities are becoming increasingly blurred. A dominant trend in the market is the rise of “end-to-end” or “one-stop-shop” service providers . This is driving a wave of consolidation, with a staggering 244 publicly announced M&A transactions involving CDMOs between and alone . Large CDMOs are acquiring CROs to offer a seamless transition from clinical research to manufacturing, while some CROs are building or buying manufacturing capabilities. The strategic goal is to capture a client early in the discovery phase and guide them through the entire value chain, minimizing the friction, time, and risk associated with transferring a project between multiple vendors. While the functional distinctions remain useful, the market itself is moving toward a more holistic, integrated service model.

The Core Value Proposition: Why Outsource in the First Place?

The dramatic growth of the CDMO market is not an accident; it is a direct response to the fundamental economic and scientific pressures of modern drug development. Pharmaceutical and biotech companies, from virtual startups to Big Pharma, turn to CDMOs for a compelling set of strategic advantages that go far beyond simple cost reduction.

1. Capital De-Risking and Cost Efficiency

Bringing a new drug to market is a monumental financial undertaking, with the total investment estimated to be as high as $2.6 billion . A significant portion of this cost is the capital expenditure required to build and validate cGMP-compliant manufacturing facilities. For a niche product like a sterile injectable or a nasal spray, this can involve millions in specialized equipment and classified manufacturing space . Outsourcing to a CDMO completely eliminates this massive upfront capital investment, converting a prohibitive CapEx into a predictable, project-based operational expenditure (OpEx) . This is not just a cost-saving measure; it’s a strategic de-risking of the entire development process. Given the high attrition rate of drug candidates, building a dedicated facility for a product that may never reach the market is a gamble most companies, especially smaller ones, cannot afford to take.

2. Accelerated Speed-to-Market

In the hyper-competitive pharmaceutical industry, time is money in its most literal sense. Every day a drug is on the market under patent protection is a day of revenue generation. Partnering with a competent CDMO can significantly expedite the drug development process . CDMOs offer ready-to-use, qualified equipment and experienced personnel, eliminating the long lead times associated with building a new facility or purchasing and validating new equipment . Their streamlined workflows, project management expertise, and experience in overcoming common manufacturing challenges can shave months, or even years, off a development timeline, providing a crucial competitive edge .

3. Access to Specialized Expertise and Technology

The era of the simple small-molecule pill is giving way to an age of incredible complexity, dominated by biologics, antibody-drug conjugates (ADCs), cell and gene therapies, and other novel modalities . No single company can be an expert in every area. CDMOs have become deep reservoirs of specialized knowledge and technology . A company developing a highly potent API (HP-API) can partner with a CDMO that has dedicated containment facilities and years of experience handling such compounds. A biotech working on a complex biologic can leverage a CDMO’s state-of-the-art single-use bioreactors and advanced analytical characterization tools . This access-on-demand model allows even the smallest virtual company to utilize world-class capabilities without owning them.

4. Scalability and Flexibility

The journey of a drug is unpredictable. A candidate might show spectacular results in Phase II, requiring a rapid scale-up of production for Phase III trials. Conversely, a commercial product might face new competition, necessitating a scale-down of manufacturing. Maintaining in-house facilities with fixed capacity makes it difficult and inefficient to respond to these fluctuations . CDMOs provide essential flexibility and scalability . They can adjust production volumes based on project needs, allowing their clients to remain agile and responsive to clinical outcomes and market dynamics without the financial burden of underutilized or overstrained internal capacity .

5. Regulatory Navigation

Navigating the global regulatory landscape is one of the most daunting aspects of drug development. The requirements of the FDA, EMA, and other international bodies are complex, ever-changing, and rigorously enforced . Experienced CDMOs have dedicated regulatory affairs teams and a proven track record of successful inspections and submissions . They have manufactured numerous products for global markets and understand the nuances of cGMP compliance, quality management systems, and data integrity . Leveraging this expertise helps sponsor companies avoid common pitfalls, reduce regulatory risk, and ensure a smoother path to approval.

Ultimately, the decision to outsource represents a fundamental strategic trade-off. A company relinquishes direct, hands-on control over its day-to-day manufacturing operations. In exchange, it gains access to speed, specialized expertise, capital efficiency, and scalability—the very assets needed to compete and succeed in the modern pharmaceutical industry. The various CDMO engagement models we will now explore are, at their core, different frameworks for managing this crucial trade-off between control and access.

The Spectrum of Engagement: A Deep Dive into CDMO Business Models

The relationship between a pharmaceutical company and a CDMO can range from a simple, one-time transaction to a deeply integrated, multi-decade alliance. The business model that governs this relationship is the blueprint that defines roles, responsibilities, financial terms, and, most importantly, how risk and reward are shared. Understanding this spectrum of engagement is critical for aligning your outsourcing strategy with your specific project needs and corporate goals. We can broadly categorize these models into two pillars: the transactional and the relational.

The Transactional Pillar: Fee-for-Service (FFS) and Its Variants

Transactional models are the workhorses of the CDMO world. They are built on the principle of a clear, defined exchange: the CDMO provides a specific service, and the client pays a specific price. These models are characterized by their clarity, predictability, and relatively low level of integration between the two parties.

The Fee-for-Service (FFS) Model: The À La Carte Approach

The Fee-for-Service (FFS) model is the most straightforward and widely adopted engagement structure in the industry . It functions like an à la carte menu for pharmaceutical services.

Mechanics: In an FFS arrangement, the client pays a pre-negotiated, fixed fee for a discrete, well-defined task or service . This could be the development of a specific formulation, the execution of an analytical testing protocol, or the manufacturing of a single cGMP batch. The contract is built around a detailed Scope of Work (SOW) that outlines the exact deliverables, timelines, and specifications. The relationship is fundamentally transactional: the CDMO is compensated for the successful completion of the specified service .

Pros:

• Budgetary Clarity and Control: The primary advantage of the FFS model is its financial predictability. Costs are transparent and agreed upon upfront, allowing pharmaceutical companies to manage their project budgets with a high degree of certainty . This clarity is invaluable for financial planning and for securing funding, especially for smaller companies.
• Intellectual Property (IP) Protection: In a standard FFS contract, the sponsoring pharmaceutical company retains full and unencumbered ownership of its product and any intellectual property directly related to it . The CDMO is a service provider, not an IP partner. This clean delineation of IP rights is a critical advantage, ensuring the client maintains complete control over its most valuable assets.
• Flexibility in Partner Selection: The transactional nature of FFS allows companies to select the best-in-class provider for each specific task. A company might use one CDMO for early-stage formulation work and a different, larger CDMO with more scale for commercial manufacturing, without being tied to a single partner.

Cons:

• Misaligned Incentives and Limited Efficiency: This is the most significant strategic drawback of the FFS model. The CDMO is incentivized to complete the task exactly as defined in the SOW to get paid. There is little to no financial incentive for them to innovate, optimize the process for greater efficiency, or proactively solve problems that fall outside the strict contractual boundaries . This can lead to a “check-the-box” mentality, where the CDMO does what is required but not necessarily what is best for the long-term health of the project. For complex development programs, this lack of proactive partnership can result in significant efficiency losses.
• Rigidity and the Peril of “Scope Creep”: The FFS model’s strength—its tightly defined scope—is also its greatest weakness. Drug development is rarely a linear process. Unforeseen scientific challenges are the norm, not the exception. Any deviation from the original SOW, no matter how necessary, requires a formal change order. This process of negotiating, pricing, and approving change orders can introduce significant delays and dramatically inflate the project’s final cost .
• Potentially Higher Costs: While appearing predictable, FFS proposals often include a built-in risk premium. The CDMO must price the project to cover its own risk of unforeseen complications or inefficiencies. This can result in higher upfront costs compared to more flexible models where risk is shared differently . The client pays a premium for the budget certainty the model provides.

Best For: The FFS model is ideally suited for projects where the process is well-understood and the scope is stable and clearly definable. This includes routine analytical testing, late-stage clinical manufacturing of a well-characterized product, or established commercial manufacturing where the goal is simply reliable execution, not innovation.

Variants on a Theme: Time & Materials (T&M) and Fixed-Price

Two common variants of the transactional model adjust the balance of financial risk:

• Time and Materials (T&M): In a T&M model, the client pays for the actual hours of labor and the cost of materials consumed by the CDMO . This model offers maximum flexibility, making it suitable for very early-stage, exploratory work where the scope is impossible to define. However, it places all the financial risk on the client. If the project takes longer than expected, the budget is open-ended, requiring strong oversight and trust to prevent costs from spiraling .
• Fixed-Price Contracts: This is the most rigid form of the FFS model, where a single price is set for an entire, large-scale project . It offers the client absolute budget certainty, which can be attractive for securing board approval or managing investor expectations. However, to accept this level of risk, the CDMO will build the largest possible contingency buffer into its price, often making it the most expensive option. Furthermore, it demands an exceptionally detailed and immutable Scope of Work, leaving virtually no room for flexibility .

The transactional pillar, particularly the FFS model, treats the CDMO as a vendor, not a partner. For simple, predictable tasks, this is an efficient and effective approach. However, for the complex, multi-year journey of developing an innovative new medicine, this transactional mindset can become a significant liability. The model’s inherent rigidity and potential for misaligned incentives can stifle the very collaboration, adaptability, and proactive problem-solving required to navigate the unpredictable challenges of drug development. This fundamental conflict is what has driven the industry to seek more relational and integrated models of engagement.

The Relational Pillar: Full-Time Equivalent (FTE) and Strategic Partnerships

In stark contrast to the transactional nature of FFS, relational models are built on the foundation of long-term collaboration, deep integration, and shared objectives. These engagements are less about purchasing a service and more about building a partnership. They are designed for complex, dynamic projects where flexibility and collaborative problem-solving are more valuable than the rigid predictability of a fixed scope.

The Full-Time Equivalent (FTE) Model: Your Extended Workbench

The Full-Time Equivalent (FTE) model represents a significant step away from task-based compensation and toward a resource-based approach. It is a powerful tool for companies needing to augment their internal R&D capabilities with dedicated external expertise.

Mechanics: In an FTE agreement, the client pays a fixed monthly or annual rate to the CDMO in exchange for the dedicated time and effort of a specific number of scientists or technicians—the “Full-Time Equivalents” . The client is essentially “renting” a dedicated team at the CDMO, which functions as an extension of their own in-house department . The payment is for the team’s dedicated effort, not for a predefined list of deliverables. This is a crucial distinction from the FFS model .

Pros:

• Unparalleled Flexibility: The FTE model’s greatest strength is its agility. Since the client is paying for the team’s time, that team can be pivoted to new tasks, different molecules, or alternative experimental approaches on very short notice, without the need for cumbersome contract renegotiations or change orders . This is invaluable during early-stage discovery and process development, where the scientific path is uncertain and the ability to “fail fast” and quickly change direction is a key driver of efficiency .
• Deep Team Integration and Collaboration: The FTE team becomes deeply embedded in the client’s project. They participate in regular team meetings, share data freely, and develop a profound understanding of the project’s scientific context and strategic goals . This fosters a highly collaborative environment where the external team feels a true sense of ownership and accountability for the project’s success, operating as a genuine partner rather than a vendor .
• Enhanced Responsiveness and Communication: With a dedicated team, the client has direct and immediate access to the scientists working on their project . This facilitates rapid communication, quick decision-making, and real-time problem-solving, eliminating the communication bottlenecks that can plague more siloed, transactional relationships.

Cons:

• Financial Risk Rests with the Client: The FTE model’s flexibility comes at a price: the client bears the full risk of productivity. The client pays for the team’s time and effort, regardless of the scientific outcome . If experiments fail to yield results or a particular synthetic route proves to be a dead end, the cost is borne entirely by the client. This model guarantees effort, not results.
• Requires Significant Management Oversight: An FTE engagement is not a “set it and forget it” arrangement. It requires active and continuous management from the client’s side to set priorities, direct the team’s activities, and ensure that their efforts remain aligned with the project’s evolving goals . This management overhead can be a significant resource drain for lean organizations.
• The Criticality of Trust: The entire model is predicated on a high degree of trust between the client and the CDMO . The client must trust that the CDMO is providing skilled, motivated, and productive personnel who are working efficiently on their behalf. Any suspicion that the CDMO is simply “running the clock” to maximize hours can quickly erode the relationship and undermine the model’s effectiveness .

Best For: The FTE model is the gold standard for early-stage, high-uncertainty R&D projects. It is ideal for drug discovery, lead optimization, and early process development, where the scientific path is unpredictable and flexibility is paramount. It is also an excellent solution for companies that need to augment their internal R&D capacity for a sustained period without adding permanent headcount.

The Strategic Partnership Model: All In, Together

The strategic partnership, sometimes referred to as a strategic alliance, represents the deepest level of integration and collaboration between a pharmaceutical company and a CDMO. This model transcends the client-vendor dynamic entirely, creating a long-term, symbiotic relationship where both parties are mutually invested in the ultimate commercial success of the product.

Mechanics: A strategic partnership is a bespoke, long-term agreement that is far more comprehensive than a standard service contract. It often involves shared governance structures, such as joint steering committees that make key strategic decisions together . Crucially, these partnerships frequently incorporate risk- and reward-sharing mechanisms. Instead of simple fees, the CDMO’s compensation might be tied to the achievement of major development milestones (e.g., successful Phase III trial, regulatory approval), or it could even include a share of future product royalties or sales revenue .

Pros:

• Perfectly Aligned Incentives: This is the model’s defining advantage. By linking the CDMO’s financial success directly to the product’s success, their incentives become perfectly aligned with the client’s . The CDMO is no longer motivated to simply complete tasks; they are motivated to do whatever it takes—innovate, improve efficiency, solve tough problems—to help the drug succeed in the market. This transforms the relationship from a service transaction to a shared mission.
• Proactive Innovation and Long-Term Investment: The security and long-term nature of the partnership encourage the CDMO to make proactive investments in new technologies, process improvements, or dedicated facility expansions that will specifically benefit the client’s product portfolio. They are investing in the shared future, not just fulfilling a current contract.
• Enhanced Supply Chain Security and Predictability: For a commercial product, a strategic partnership provides an unparalleled level of supply chain resilience. The client has a dedicated partner with a deep understanding of their product and a vested interest in ensuring an uninterrupted supply. This mitigates the risks associated with capacity shortages or having to switch manufacturers.

Cons:

• High Commitment and Risk of “Vendor Lock-In”: Strategic partnerships are, by design, difficult and expensive to exit. The deep integration of processes, quality systems, and teams creates a high degree of dependency on a single supplier . This “lock-in” can reduce the client’s negotiating leverage over time and makes them vulnerable if the CDMO’s performance declines or if their strategic priorities shift.
• Complex Governance and Management: These partnerships require a significant investment in relationship management. The joint steering committees, regular high-level meetings, and complex financial arrangements demand substantial time and attention from senior leadership on both sides to function effectively.
• Intensive and High-Stakes Selection Process: Choosing a strategic partner is akin to a corporate marriage. The due diligence process must be incredibly deep and exhaustive, evaluating not just technical capabilities and quality systems, but also long-term financial stability, strategic vision, and, crucially, cultural compatibility. A mismatch in culture or communication styles can doom the partnership, regardless of technical excellence.

Best For: Strategic partnerships are best suited for companies with a robust pipeline of products or a late-stage asset with high commercial potential (a potential “blockbuster”). They are ideal for establishing the long-term, secure manufacturing supply chain for a major commercial product or for managing the development and manufacturing of an entire portfolio of related drugs.

The journey from the transactional FFS model to the deeply relational strategic partnership is a journey along a spectrum of increasing integration and shared risk. As a company moves along this spectrum, the potential rewards in terms of innovation, efficiency, and alignment grow significantly. However, so too does the level of mutual dependency and the strategic consequences of a failed partnership. The key is to choose the point on that spectrum that best matches the risk profile of the project and the strategic DNA of the company.

The New Frontier: Innovative and Hybrid CDMO Models

The pharmaceutical outsourcing market is anything but static. As the needs of drug developers evolve and as new technologies come online, the traditional engagement models are being challenged and augmented by innovative new structures. These hybrid models are not merely academic exercises; they are market-driven responses to the perceived gaps and limitations of the established transactional and relational pillars. They represent a new frontier in how value is created, captured, and shared between pharmaceutical companies and their CDMO partners.

The Rise of the Hybrid CDMO: The Best of Both Worlds?

Hybrid models seek to combine the most attractive features of different traditional models, creating novel value propositions that are tailored to the specific needs of the modern biopharma landscape. Two prominent examples are reshaping expectations of what a CDMO partnership can be.

The Shilpa Medicare Model: A Dual-Pronged Strategy

A fascinating and disruptive hybrid model has been pioneered by companies like India-based Shilpa Medicare. This model fundamentally redefines the CDMO’s role, elevating it from a pure service provider to a co-developer of pharmaceutical assets .

Mechanics: The Shilpa model operates on a dual-pronged strategy. On one hand, it offers a comprehensive suite of traditional CDMO services—from discovery support to clinical and commercial manufacturing—for its clients’ proprietary pipeline assets . On the other hand, the company leverages its own R&D and manufacturing expertise to develop its own portfolio of “off-the-shelf” novel formulations and late-stage products. These fully developed assets are then made available for exclusive business-to-business (B2B) licensing to other pharmaceutical companies .

Pros for the Pharmaceutical Client: This dual approach provides clients with unprecedented flexibility and multiple, de-risked pathways to market. A company with its own early-stage molecule can engage Shilpa as a traditional CDMO partner. Alternatively, a company looking to quickly enter a new therapeutic area or bolster its commercial portfolio can bypass years of development risk and uncertainty by simply licensing one of Shilpa’s pre-developed, market-ready products . As Vishnukant C. Bhutada, Managing Director of Shilpa Medicare, stated, “Our goal is to offer pharmaceutical and biotech customers multiple flexible pathways to bring commercial products to market” .

Pros for the CDMO: For the CDMO, this model is a strategic masterstroke. It creates a powerful new revenue stream derived from licensing fees, milestones, and royalties, which typically offer much higher margins than traditional fee-for-service work. It allows the CDMO to capture more value from its own internal innovations and moves it up the value chain from a service provider to a product-oriented company with its own intellectual property.

The “High-Science, High-Touch” (HSHT) Model

While the Shilpa model is a structural and commercial innovation, the “High-Science, High-Touch” (HSHT) model is a philosophical and operational one. It is less a specific type of contract and more a distinct service delivery model designed to address a critical gap in the market .

Mechanics: The HSHT model is built on the premise of combining cutting-edge, rigorous scientific expertise (“High-Science”) with a deeply personalized, flexible, and client-centric project management approach (“High-Touch”) . It aims to provide the deep technical and regulatory knowledge expected of a large, global CDMO while delivering the agility, responsiveness, and senior-level attention characteristic of a smaller, boutique firm.

Why it’s a “Hybrid”: This model is a direct response to a common dilemma faced by many drug developers, particularly smaller ones. They often feel that large CDMOs can be bureaucratic, slow to make decisions, and lacking in transparent communication, making a small client feel like a low priority . Conversely, they may worry that smaller, boutique CDMOs, while more agile, might lack the depth of experience, breadth of technology, or robust quality systems needed to handle a complex program . The HSHT model seeks to resolve this paradox by creating a culture and operational structure that delivers the best of both worlds.

Target Audience: The HSHT approach is particularly compelling for small, virtual, and emerging biopharmaceutical companies . These companies are often working on the cutting edge of science and have lean internal teams. They need more than just outsourced capacity; they need a true scientific partner—an extension of their own team—who can provide strategic guidance, collaboratively solve complex technical challenges, and navigate the daunting regulatory pathway to the clinic .

These emerging hybrid models are a clear sign of a maturing market. They demonstrate that CDMOs are no longer content to be passive recipients of work orders. Instead, they are actively seeking new ways to create and capture value. The Shilpa model achieves this by generating its own licensable IP, effectively becoming a product company. The HSHT model achieves this by creating a superior, differentiated service experience for a specific and underserved segment of the market. For pharmaceutical companies, these innovations offer new and powerful strategic options for bringing medicines to patients faster and more efficiently.

The Impact of Technology: Smart Manufacturing and the Integrated (IDMO) Future

The evolution of CDMO models is not just being driven by new business strategies; it is also being profoundly shaped by technology. The convergence of digital technologies known as Industry 4.0 is transforming the factory floor, enabling new levels of efficiency, quality, and flexibility that are, in turn, enabling entirely new operational models for pharmaceutical outsourcing.

Industry 4.0 in Pharmaceutical Manufacturing

The concept of the “smart factory” is no longer a futuristic vision; it is rapidly becoming a reality in the CDMO sector. Leading CDMOs are aggressively integrating a suite of advanced digital tools into their operations:

• Artificial Intelligence (AI) and Machine Learning (ML): AI algorithms are being used for everything from predictive maintenance on manufacturing equipment to AI-assisted visual inspection of sterile products, which can decrease rejection rates and improve yields . ML models can analyze vast datasets from past production runs to identify the critical process parameters that lead to optimal outcomes, enabling more robust and efficient manufacturing processes .
• Digital Twins: A digital twin is a virtual replica of a physical manufacturing process or facility. This technology allows CDMOs to simulate and optimize production schedules, test process changes in a virtual environment before implementing them on the factory floor, and train operators without using real materials or equipment .
• Process Automation and Robotics: Automation is being deployed to handle repetitive tasks, reduce human error, and, in sterile manufacturing, minimize human interventions to reduce contamination risk .

These technologies are not just making existing processes better; they are fundamentally changing the way drug development and manufacturing are done, leading to the emergence of a new, technology-centric outsourcing model.

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The IDMO (Integrated Development and Manufacturing Organization) Concept

The logical endpoint of this technological integration is the Integrated Development and Manufacturing Organization, or IDMO. This emerging model, particularly relevant for the incredibly complex and bespoke nature of cell and gene therapies (CGTs), represents a paradigm shift in manufacturing philosophy .

Mechanics: An IDMO leverages a network of standardized, interconnected, and fully integrated “smart” manufacturing facilities . The core principle of the IDMO model is flexible manufacturing where process modifications are managed almost entirely through software, without requiring physical hardware changes . This means that the “recipe” for manufacturing a specific cell therapy can be developed and refined at one site and then digitally transferred to any other IDMO facility in the world, which can then execute the exact same process on its standardized equipment platform.

Impact on Outsourcing: This model promises to solve some of the most significant bottlenecks in advanced therapy manufacturing. Technology transfer, traditionally a lengthy, complex, and risk-prone process that can take months of painstaking work, could be streamlined into a secure, validated data transfer that takes a fraction of the time . This would dramatically accelerate timelines, reduce costs, and make it far easier to scale out manufacturing to multiple global sites to meet patient demand .

The rise of these technology-driven models has a profound implication for any company selecting a CDMO partner today. It suggests that a critical component of due diligence must now be an assessment of a potential partner’s digital maturity. A CDMO that is heavily invested in Industry 4.0 and is moving toward an IDMO-like model is not just buying efficiency; it is future-proofing its operations. Choosing a partner that is a leader in digital manufacturing is a strategic decision to de-risk future scale-up and ensure access to the most efficient and reliable production technologies as they become the industry standard. Technology is no longer just a tool to support the business model; it is becoming the business model itself.

The Strategic Playbook: Selecting, Negotiating, and Managing Your CDMO Partnership

Understanding the spectrum of CDMO models is the first step. Translating that understanding into a successful partnership requires a disciplined, strategic approach to selection, negotiation, and ongoing management. A poorly chosen partner or a badly constructed contract can undermine even the most promising therapeutic asset. This playbook provides a framework for making informed decisions, protecting your interests, and building a foundation for a productive, long-term collaboration.

The Right Fit: A Framework for Choosing Your Model

There is no single “best” CDMO model. The optimal choice is highly contextual and depends on a careful evaluation of your company, your project, and your strategic objectives. The decision-making process should be guided by a clear-eyed assessment of several key variables:

• Company Stage and Size: A venture-backed virtual biotech with a lean team and limited capital has vastly different needs than a mid-sized pharmaceutical company with established internal infrastructure or a Big Pharma giant managing a global portfolio. The virtual biotech will likely need a more hands-on, partnership-oriented model (like FTE or HSHT), while Big Pharma may use a mix of transactional FFS for mature products and strategic partnerships for key pipeline assets.
• Project Stage: The level of uncertainty and risk changes dramatically as a project moves from pre-clinical discovery to commercialization. Early-stage projects with high scientific uncertainty are well-suited to the flexibility of an FTE model. In contrast, a late-stage Phase III or commercial product with a locked-in process is a perfect candidate for a predictable, execution-focused FFS or strategic partnership model.
• Product Complexity: Manufacturing a standard oral solid dose tablet is a world away from producing a personalized CAR-T cell therapy. The more complex, novel, and sensitive the product and its manufacturing process, the greater the need for a deeply integrated, collaborative partnership model. Complex biologics and CGTs almost always necessitate a relational model over a transactional one.
• Risk Tolerance and Financial Profile: The company’s appetite for risk is a critical factor. A company that prioritizes absolute budget certainty above all else will gravitate toward a Fixed-Price or FFS model, accepting the associated higher costs and rigidity. A company that is comfortable sharing in the risks of development to gain the potential rewards of a more efficient or innovative outcome will be more open to performance-based strategic partnerships.
• Strategic Goals: Is this a one-off project, or is it the first product from a new technology platform that will generate a pipeline of future candidates? For a single, discrete project, a transactional model may suffice. For a platform technology, building a long-term strategic partnership with a CDMO that can grow with the platform is a far more strategic approach.

To aid in this decision-making process, the following table provides a comparative analysis of the core CDMO business models across key strategic dimensions.

The Art of the Deal: Navigating Contracts and Intellectual Property

Once a model and a potential partner have been selected, the focus shifts to the contract. The CDMO agreement is more than just a legal document; it is the operational blueprint for the entire relationship. A well-crafted contract can prevent misunderstandings, mitigate risks, and provide a clear framework for resolving issues. A poorly constructed one can be a source of constant friction and, in the worst case, can lead to project failure.

Beyond the Handshake: Essential Clauses in a CDMO Agreement

While every contract is unique, several clauses are universally critical for a successful CDMO partnership:

• Scope of Work (SOW): This is the heart of any transactional agreement. It must meticulously detail the specific services, deliverables, timelines, specifications, and acceptance criteria . An ambiguous SOW is a recipe for disputes over “scope creep.”
• Quality Agreement (QAA): The QAA is a legally binding document, separate from but referenced by the main services agreement, that defines the specific quality-related roles and responsibilities of both parties . It covers everything from materials management and deviation protocols to batch release procedures and audit rights, ensuring alignment on cGMP compliance.
• Change Control Process: Given the dynamic nature of drug development, a robust and clearly defined process for managing changes is essential . The contract must specify how changes to the scope, process, or specifications will be requested, evaluated for impact (on cost and timeline), approved, and documented.
• Governance and Communication: The contract should establish the formal governance structure for the relationship. This includes defining the key points of contact, the frequency and format of progress reports and meetings (e.g., weekly operational calls, quarterly joint steering committee meetings), and the escalation pathway for resolving issues .
• Termination Clauses: This section outlines the conditions under which either party can terminate the agreement . It should cover termination for cause (e.g., material breach of contract, significant quality failure) and termination for convenience (i.e., without cause), specifying the required notice periods, financial consequences, and obligations for technology transfer upon termination.

Protecting the Crown Jewels: A Guide to IP in CDMO Partnerships

Of all the clauses in a CDMO agreement, none is more strategically critical than the one governing Intellectual Property (IP). IP is the lifeblood of any pharmaceutical company, and protecting it is paramount. The negotiation of IP rights in a CDMO relationship is complex due to a fundamental tension:

The client’s primary goal is to ensure it owns all IP directly related to its product—the composition of matter, the specific formulation, and any unique applications. This is essential for maintaining its freedom to operate and its competitive advantage .

The CDMO’s primary goal is to retain ownership of any improvements or innovations related to its own general processes, technologies, and platforms. These platform improvements are the CDMO’s own “crown jewels,” and giving them away to one client would prevent them from using those improvements to benefit other clients, thereby eroding their own competitive advantage .

Navigating this tension requires a clear and carefully negotiated approach to IP ownership. Common models include:

• “Customer Owns All Product IP”: A common approach where the contract specifies that any IP developed that is solely related to the client’s product or molecule is owned by the client. IP related to the CDMO’s general platform technology remains with the CDMO .
• “Ownership Follows Inventorship”: This legal default assigns ownership to the party whose employees invented the IP. This can be problematic in a collaborative environment where inventions are often conceived jointly, and it may favor the CDMO, whose employees are performing the hands-on work .
• Joint Ownership: While it can seem like a fair compromise, joint ownership is often the most problematic option. It can create complex legal and commercial issues regarding who has the right to license, enforce, or sell the IP without the other party’s consent .
• Licensing Models: A practical solution is for one party to own the IP while granting the other a broad, royalty-free license to use it. For example, the client could own a process improvement, but grant the CDMO a license to use that improvement for other clients (often excluding direct competitors). Conversely, the CDMO could own the improvement and grant the client a license to use it and to transfer it to another manufacturer if needed .

A critical risk to mitigate is IP contamination, which occurs when a CDMO inadvertently incorporates its own background IP, or the IP of another client, into your product . A strong contract will include representations and warranties from the CDMO that this will not occur and will clearly define the client’s right to use any necessary CDMO background IP to manufacture the product elsewhere if the partnership ends .

The negotiation of these IP terms is not a mere legal formality; it is a strategic exercise that defines the long-term power dynamic of the partnership. A poorly structured IP clause can lead to a situation of “vendor lock-in,” where the client becomes so dependent on the CDMO’s proprietary processes or background IP that it becomes practically and financially impossible to move manufacturing to another partner . This creates a dangerous strategic dependency that can be far more damaging in the long run than any upfront cost savings.

Data-Driven Due Diligence: Using Patent Intelligence to Vet Partners

The traditional due diligence process for selecting a CDMO involves RFPs, site audits, and reference checks. These are all essential, but they often rely on information provided and curated by the CDMO itself. To add a powerful, objective layer of verification to this process, savvy pharmaceutical companies are now turning to patent intelligence.

CDMOs have long used patent data as a business development tool. By monitoring the patent applications of pharmaceutical companies using services like DrugPatentWatch, they can identify potential clients with new molecules that will soon require development and manufacturing support . They analyze these patents to understand the technical challenges a company is facing and then tailor their sales pitch to highlight their relevant capabilities .

A pharmaceutical company can—and should—reverse this process.

The Concept: Reverse-Engineering the Sales Pitch

By analyzing the patent portfolio of a potential CDMO partner, a company can gain unbiased, data-driven insights into their true technical capabilities, their level of innovation, and their areas of genuine expertise. It provides a “trust but verify” mechanism to validate the claims made in their marketing materials and RFP responses.

Actionable Steps with Patent Intelligence Platforms:

A company can use a comprehensive patent database and analytics platform like DrugPatentWatch to execute this strategy:

1. Search for Patents Assigned to the CDMO: Conduct a thorough search for all patents and patent applications where the potential CDMO partner is listed as the assignee .
2. Assess Technological Alignment and True Expertise: A CDMO may claim to be a world leader in, for example, amorphous solid dispersion technology. Does their patent portfolio back this up? Are they actively patenting new processes, equipment modifications, or formulation approaches in this specific area? A robust portfolio of relevant patents is a strong, objective indicator of deep technical expertise. A lack of patenting activity in a claimed area of expertise should be a red flag that warrants further questioning .
3. Identify the Innovation Trajectory: Is the CDMO’s patent portfolio current and growing, or is it composed primarily of older patents filed a decade ago? A steady stream of recent patent applications suggests a culture of continuous innovation and investment in R&D. A stagnant portfolio might indicate that their technology is becoming outdated.
4. Map Their Collaborative Ecosystem: Patent documents list all inventors and assignees. Co-assigned patents can reveal the CDMO’s other development partners and clients. If a CDMO frequently co-patents with companies known for their high quality and scientific rigor, it can be a positive signal about their own standards and collaborative capabilities.

Using patent intelligence in this way transforms it from a simple legal tool into a powerful instrument for strategic due diligence. It allows a company to look past the sales pitch and assess a CDMO’s capabilities based on the objective, public record of their innovations. This data-driven approach does not replace traditional due diligence, but it provides a critical layer of validation that can significantly de-risk the partner selection process and help ensure that you are partnering with a true innovator, not just a capable manufacturer.

Gazing into the Crystal Ball: The Future of Pharmaceutical Outsourcing

The landscape of pharmaceutical outsourcing is in a state of perpetual evolution, driven by the relentless pace of scientific discovery, technological advancement, and shifting economic pressures. The journey from the transactional CMO to the integrated CDMO, and now to the innovative hybrid and technology-driven IDMO, is not a final destination but another stop on a continuing journey. As we look to the future, the trends shaping the industry today offer a clear glimpse of the world to come—a world defined by even deeper symbiosis, greater specialization, and the pervasive influence of data.

Conclusion: The Symbiotic Future of Pharma and the CDMO

The central theme of the last two decades has been the transformation of the CDMO from a peripheral vendor into a central, indispensable partner in the pharmaceutical ecosystem. This trend is set to accelerate. The future of drug development is not one of monolithic companies doing everything in-house, nor is it one of purely transactional outsourcing. Instead, the future is symbiotic.

Pharmaceutical and biotech companies will continue to specialize in their core competency: the high-risk, high-reward process of discovery and early-stage research. They will be the engines of innovation, identifying new biological targets and creating novel therapeutic molecules. CDMOs, in turn, will continue to professionalize and perfect their core competency: the complex, capital-intensive, and highly regulated process of turning those molecules into safe, effective, and scalable medicines.

The successful partnerships of the future will be built on a foundation of transparency, flexibility, and true strategic alignment. The choice of engagement model will become an even more critical strategic decision, with companies employing a sophisticated, portfolio-based approach—using transactional models for simple tasks and deeply integrated, risk-sharing partnerships for their most innovative and valuable assets. The one-size-fits-all approach is dead; the future belongs to those who can master the art of building the right partnership, with the right model, for the right project. In this symbiotic future, the success of the innovator and the success of the manufacturer will be inextricably linked.

The global Contract Development and Manufacturing Organization (CDMO) market size was valued at USD 238.92 billion in . The market is projected to grow from USD 255.01 billion in to USD 465.24 billion by , exhibiting a CAGR of 9.0% during the forecast period.

— Fortune Business Insights

Key Takeaways

For the busy executive tasked with navigating this complex landscape, the following key takeaways distill the most critical, actionable insights from this analysis:

• Model Selection is a Strategic Act: The choice of a CDMO engagement model (e.g., FFS, FTE, Strategic Partnership) is not a simple procurement decision. It is a high-stakes strategic choice that fundamentally defines the risk profile, cost structure, IP rights, and collaborative potential of the partnership. It must be aligned with the specific needs of the project, the company’s stage of development, and its long-term corporate goals.
• Align Incentives to Mitigate Risk: Transactional models like Fee-for-Service (FFS) are best suited for low-risk, well-defined projects where execution is key. For complex, innovative, and unpredictable development programs, relational models like Full-Time Equivalent (FTE) and Strategic Partnerships are essential, as they provide the flexibility and aligned incentives needed to foster true collaboration and proactive problem-solving.
• Hybrid Models Offer New Strategic Pathways: The emergence of innovative hybrid models, such as those offering licensable “off-the-shelf” products alongside traditional services, signals a maturation of the market. These models provide new, flexible, and de-risked pathways to market and should be considered as part of a comprehensive outsourcing strategy.
• Negotiate IP for Future Freedom: Intellectual Property ownership is one of the most critical and contentious points of negotiation. A poorly constructed IP clause can lead to “vendor lock-in,” creating a long-term strategic dependency on your CDMO. Negotiate IP terms not just to protect your current asset, but to preserve your future freedom of action.
• Leverage Data for Smarter Due Diligence: Do not rely solely on a CDMO’s self-reported capabilities. Use objective, data-driven tools to verify their claims. Leveraging patent intelligence platforms like DrugPatentWatch to analyze a potential partner’s patent portfolio provides a powerful, unbiased method to assess their true technical expertise, innovation culture, and de-risk the selection process.
• Digital Maturity is a Key Differentiator: The future of manufacturing is digital. A CDMO’s investment in Industry 4.0 technologies (AI, digital twins, automation) is a leading indicator of its future efficiency, quality, and scalability. Prioritize partners who are on the cutting edge of this digital transformation to future-proof your supply chain.

Frequently Asked Questions (FAQ)

1. At what stage of development should we consider switching from a flexible FTE model to a more structured Fee-for-Service model?

This is a critical transition point. The ideal time to switch is when the level of uncertainty in your project significantly decreases. An FTE model excels during early process development and optimization, when you are exploring multiple variables and the exact path forward is unknown. You should consider transitioning to an FFS model when you have:

• A “Locked” Process: The core manufacturing process has been defined, key parameters are understood, and you are no longer making significant changes to the fundamental “recipe.”
• Validated Analytical Methods: The methods for testing your product’s quality, purity, and stability are robust, validated, and yield consistent results.
• A Clear Scope for the Next Phase: You can confidently define the exact deliverables for the next stage (e.g., “manufacture three cGMP validation batches according to Process X and test them using Analytical Methods Y and Z”).This transition often occurs between Phase I and Phase II, or sometimes between Phase II and Phase III, once the process is robust enough to be clearly defined in a detailed Scope of Work.

2. How can a small virtual biotech with limited resources effectively manage a strategic partnership with a large, global CDMO?

This can be challenging, as there is often an asymmetry in size and resources. The key is to establish a robust governance structure and clear communication protocols from the outset.

• Appoint a Dedicated Alliance Manager: Even in a small company, one person must be the designated “owner” of the relationship. This person is responsible for day-to-day communication, tracking progress against goals, and managing the governance structure.
• Insist on a Joint Steering Committee (JSC): The contract must mandate a JSC with senior leadership from both companies that meets regularly (e.g., quarterly). This ensures that your project has visibility at the executive level of the CDMO and provides a formal channel for escalating issues that cannot be resolved at the project team level.
• Focus on a Detailed Project Plan: Co-develop an extremely detailed project plan with clear milestones, deliverables, and timelines. This becomes the objective “source of truth” that both teams work from and helps prevent your project from being deprioritized.
• Leverage the CDMO’s Project Manager: Treat the CDMO’s assigned Project Manager as a critical member of your own team. Build a strong, collaborative relationship with them, as they are your primary advocate within the CDMO’s organization.

3. What are the key differences in contracting with a CDMO for a small molecule versus a complex cell therapy?

The differences are profound and reflect the underlying complexity of the products.

• Small Molecule Contracts: These are often more straightforward. The manufacturing processes are typically well-understood, raw materials are chemicals with defined specifications, and the quality attributes are well-characterized. Contracts can often be structured as FFS with detailed SOWs because the process is highly definable.
• Cell Therapy Contracts: These are vastly more complex and almost always require a relational model (FTE or Strategic Partnership). The “starting material” is often a patient’s own cells, making each batch unique. The manufacturing process is a biological process, not a chemical synthesis, and is subject to inherent variability. Key contractual differences include:
  • Chain of Custody and Identity: Extremely detailed clauses are required to track the patient’s cells from collection to re-infusion, ensuring the right product goes back to the right patient.
  • “Batch Success” Definition: Defining what constitutes a “successful” batch is much more complex and must account for biological variables like cell viability and potency, which may not be fully under the CDMO’s control.
  • IP Complexity: The process is the product. Innovations in how the cells are handled, grown, or modified are incredibly valuable. IP clauses must be meticulously negotiated to define ownership of these critical process improvements.
  • Regulatory Interaction: The contract must specify a highly collaborative approach to interacting with regulatory agencies, as the manufacturing process is under intense scrutiny.

4. If a CDMO develops a significant process improvement while working on our product under an FFS model, who typically owns that IP?

This is a classic area of dispute and highlights a key weakness of the FFS model. The “typical” answer depends entirely on what is written in the contract’s IP clause. There are several possibilities:

• If the contract is silent or ambiguous: Ownership will likely default to “inventorship,” meaning the CDMO’s employees who invented the improvement would be the inventors, and the CDMO would own the IP. This is often a disastrous outcome for the client.
• If the contract favors the client: A well-written, client-friendly contract will state that any inventions, discoveries, or improvements “arising from the performance of the Services” or “related to the Product” are owned by the client.
• If the contract favors the CDMO: A CDMO-friendly contract will state that the client owns IP solely related to its proprietary molecule, but the CDMO retains ownership of all IP related to its general manufacturing processes, platforms, and technologies, even if those improvements were developed and paid for while working on the client’s project.This is precisely why IP must be negotiated with extreme care. The best practice is to address this scenario explicitly, often resulting in a compromise where the client owns the improvement but grants the CDMO a license to use it for other projects (potentially excluding direct competitors).

5. How is the rise of biosimilars impacting the types of CDMO models being offered and chosen?

The rise of biosimilars is putting immense pressure on cost and speed, which in turn influences CDMO model selection.

• Increased Demand for End-to-End Providers: Biosimilar developers need to move incredibly fast to launch as soon as the reference product’s patent expires. They often favor large, integrated CDMOs that can provide an end-to-end “one-stop-shop” solution, from cell line development and process characterization all the way to commercial manufacturing and regulatory filing support. This minimizes the delays associated with tech transfers between different vendors.
• Pressure on Pricing Models: The primary competitive lever for biosimilars is price. Therefore, developers are extremely cost-sensitive. This leads to a preference for highly competitive, volume-driven FFS or Fixed-Price contracts for commercial manufacturing. They will often conduct extensive competitive bidding processes to drive down the cost-of-goods.
• Rise of Risk-Sharing Partnerships: For some CDMOs, biosimilars represent an opportunity to move beyond simple FFS work. Some are entering into more strategic, risk-sharing partnerships where they might co-invest in the development of a biosimilar in exchange for a share of the future profits. This allows the biosimilar developer to reduce their upfront R&D costs, while the CDMO gets to participate in the upside of a successful product launch. This trend is another example of CDMOs moving up the value chain.

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The outsourcing of pharmaceutical clinical supplies has greatly expanded over recent years. While dosage forms and packaging have traditionally been the primary focus, clinical stage active pharmaceutical ingredients (APIs) are increasingly taking center stage, and there is much to learn about the outsourcing of these materials. Clearly, without sufficient quantities of the necessary API, clinical studies cannot occur.

Outsourcing the supply of APIs for clinical studies has emerged as a highly practical, cost-effective, and widely embraced choice among small to mid-size drug developers that lack the infrastructure required for in-house production of small molecule APIs and reference standards. Entrusting the manufacturing of clinical trial APIs to a reputable API-focused CDMO specializing in small molecule development and production, like Purisys, can help these organizations to enhance efficiency, accelerate timelines, significantly reduce their own research and development expenses, obtain clinical supplies, and expedite clinical trials.

Beyond that, CDMOs offer drug sponsors operational expertise in chemistry, manufacturing and control (CMC) technologies, Good Manufacturing Practice (GMP) facilities, quality, safety, and environmental management systems. Full-service CDMOs also provide regulatory filing support and may specialize in specific chemistries or compound classes, such as cannabinoids or other compounds with potential therapeutic benefits.

There are many smaller biotech companies whose research is dependent on a domestic U.S. funding source (such as NIH, NSF, NIDA, BARDA) that require domestic manufacture of clinical trial APIs. In such cases, these companies must find a manufacturing partner capable of domestic manufacture.

Large pharmaceutical companies may also employ CDMOs if they lack a domestic manufacturing footprint, need expedited delivery or have internal capacity constraints (lack of R&D resources) to produce material for clinical trials. Companies developing controlled substances, including a recent uptick in companies researching psychotropics, must have licenses required by the Drug Enforcement Administration (DEA) to legally research, manufacture, test, import, export and distribute APIs.

What to look for in a small molecule API-focused CDMO partner

When selecting a CDMO, there are several factors that should be considered:

1. Sponsor focused

Sponsor companies should prioritize a customer-oriented partner that offers proactive solutions. Large global CDMOs often act conservatively and cause delays during the contracting process, wasting valuable development time. Smaller biotech companies must consider lead time and potential changes in trial timelines, ensuring the CDMO can pivot quickly to meet accelerated supply needs. It’s crucial to assess the CDMO’s ability to support future trials and commercialization plans, particularly in Phase III. Balancing scalability with ease of collaboration is essential, as sponsors need a partner focused on their needs and responsive to input. A customer oriented CDMO understands the client’s goals and acts efficiently to achieve them.

2. Robust technical capabilities

A successful CDMO should have proven technical capabilities. This applies to equipment, capacity, development experience/skill and knowledge across production and analytical development. Choosing a CDMO that has a track record in delivering cGMP clinical stage materials across multiple chemistries and sponsors is critical, especially since many CDMOs who claim to have clinical stage expertise have a limited complex cGMP API synthesis track record.

3. Low regulatory risk

It’s best to always work with a CDMO that has global regulatory and quality experience that has supplied trial materials to many global clinical studies. A CDMO who strictly adheres to regulatory guidelines and has extensive knowledge on the regulatory processes enhances the sponsors chances of a timely completion of the trial, and ultimately an approval. Partnering with a reliable CDMO that has well-maintained GMP facilities, a strong regulatory track record, and a robust quality system can significantly lower any regulatory risk.

Not all clinical stage drug manufacturers perform commercial manufacturing routinely and vice versa, making them subject to different regulations and inspection intervals, etc. At Purisys, we  manufacture APIs spanning preclinical to late-stage clinical studies, but also routinely manufacture products for niche (including orphan drug) commercial purposes.

Purisys also custom manufactures new chemical entities and reference standards for pharmaceutical customers. As such, Purisys is a commercial manufacturer as well as a clinical stage CDMO that undergoes ‘Six Systems GMP Inspection’ with the FDA. This is a systems-based approach to GMP and is aimed at ensuring a robust quality system model for pharmaceutical products. Purisys is routinely inspected for compliance on a regular cadence by the FDA to meet the high standards necessary for clinical and commercial manufacturing.

After selecting the right CDMO, there are a number of strategies to follow to ensure a successful partnership. We’ll cover those in our next blog. In the meantime, to learn more about our CDMO services and how we can assist with your next clinical trial, contact us today.

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