Lorna Patrick
Chief Operating Officer, Upperton
In the world of outsourced drug development and manufacturing, risk mitigation is often discussed as if it were a standard, universally embedded feature of every CDMO relationship. Biotechs expect it. Regulators assume it. CDMOs proudly reference it in brochures and slide decks. Yet the industry remains deeply divided. While some CDMOs have deliberately built their operations, project and service structures around mitigating risk, others often unintentionally operate in ways that can increase uncertainty, slow progress, and compromise programme outcomes.
The difference between the two is not subtle. It shapes the quality of communication, the reliability of timelines, and ultimately the probability that a therapy reaches patients. The CDMO environment is defined by tight budgets, specialised modalities, lean biotech teams and rising regulatory expectations. Therefore, the approach to risk taken by a CDMO is a key differentiator, as well as an operational necessity.
When Does a CDMO Create Risk?
At its core, risk in CDMO partnerships emerges when complexity, uncertainty and siloed working converge. Drug development is unpredictable by nature, and manufacturing pathways are often conditional, non-linear and sensitive to every change in input. When a CDMO overlays this inherent uncertainty with created fragmentation: multi-site operations, unclear ownership, multiple handoffs, multiple project management teams, or overly rigid processes, the result is not simply slower progress. It is the systemic amplification of risk.
Many sponsors recognise this pattern all too well. They enter a partnership hopeful, yet quickly find themselves navigating communication gaps, inconsistent data flow, or shifting points of contact. Each handoff becomes a point of vulnerability; each delay a missed milestone. Risk compounds quietly in the background, long before it emerges in the form of a late batch, an unexpected deviation or an unanticipated cost.
This is the scenario biotech companies work hardest to avoid, and it is why the most forward‑thinking CDMOs have taken a fundamentally different approach, designing their operating models not only to control risk, but to actively reduce it.
Risk Mitigation in CDMOs
A key consideration for CDMOs is preparing risk mitigation in an environment where risk is abundant. Many CDMOs rely on generic project management structures or traditional operational silos, creating miscommunication and blind spots in key projects. Meanwhile, forward thinking CDMOs structure their team structure and ways of working around early anticipation, cross-functional integration and continuity. Risk mitigation is not a separate workstream; it is embedded into every interaction, every lab process and every stage of a programme’s lifecycle.
Knowledge Continuity as Risk Mitigation
Many CDMOs treat project management as an administrative function, a scheduling and documentation exercise that exists adjacent to scientific execution. The result is an immediate gap: a project manager may be involved, but not truly embedded, and therefore cannot foresee scientific risk early, nor influence technical decisions with a full understanding of programme context. CDMOs that actively mitigate risk take a different route. Technical and project delivery staff operate as a single, integrated unit that moves through development and manufacturing as one continuous team. This eliminates the vacuum in which risks usually grow. A shift in risk mitigation means that issues are identified proactively, as opposed to reactively.
This allows risks to be identified and dealt with before they have material impact because the people managing timelines are the same people who have been working on the project from the first day it entered the research and development labs. With consistent people on your project, knowledge is maintained at every phase of the project, reducing the risks associated with knowledge loss.
CDMO Operational Structure as a Risk Consideration
One-site CDMOs significantly mitigate risk through reduced handovers, reduced complexity in moving projects through each phase, and by improving the communication by working with people who work together every day. In some CDMOs, each phase: preformulation, formulation development, analytical development, process optimisation, tech transfer, and GMP manufacturing is handled by separate, loosely connected teams. Each transition requires a handover, and introduces the possibility of misalignment, misinterpretation or delays. By contrast, one-site operations like Upperton’s Trent Gateway Facility, are built around continuity. The same programme management teams remain with the programme throughout its journey, maintaining technical memory and ensuring that every decision made early on is carried forward with clarity. This reduces uncertainty, compresses timelines and creates a risk‑mitigating through‑line from day one.
The physical design of one-site operational facilities plays a role as well. Many CDMOs operate legacy sites that have been expanded organically. They have multiple buildings, disconnected labs, and process flows that force teams to work around the architecture rather than with it. One-site operations such as Upperton’s purpose-built Trent Gateway facility take the opposite approach. They streamline the movement of materials and people, reduce contamination and deviation risk, and support efficient, linear progression from development to clinical or commercial manufacturing. By removing complexity from the environment, it removes risk from the process.
Cross Team Collaboration as a Key Risk Mitigator
Cross team collaboration may be the most significant differentiator. Risk management is not solely about tools or infrastructure, it is also about communication workflows, behaviour, and people processes. CDMOs that inadvertently increase risk often do so because teams operate under pressure, communication is reactive, or internal priorities overshadow client outcomes. Through a one-site operational model, and consistency through projects teams and ownership, teams can be encouraged to flag uncertainties early, challenge assumptions, and make decisions collaboratively. This openness is essential: when scientific and operational challenges are acknowledged early, they are manageable. When they are concealed or postponed, they have the potential to become crises.
Quality of Communication as a Risk Factor
Another dimension that distinguishes risk‑mitigating CDMOs is the quality of communication between CDMO and Biotech. Forward thinking CDMOs prioritise direct, consistent dialogue, clear client updates and meaningful technical discussions. Regular, science‑led interaction ensures there are no “unknown unknowns” accumulating in the background. Biotechs gain full visibility of progress, challenges, next steps and the rationale behind key decisions. This contributes not only to risk reduction but to trust, which is arguably the most valuable currency in outsourced development.
By viewing quality of communication as a risk factor, risk management becomes inseparable from service design. When communication is clear and teams are aligned, risk is controlled at its source. When they are absent, it doesn’t matter how many risk registers or mitigation plans are created, issues will seep into the gaps left behind.
Risk isn’t going anywhere, but some CDMOs are developing better mitigation strategies
The industry will continue to evolve and increase in complexity. With it, the expectations placed on CDMOs will rise. Whether a programme succeeds or falters will increasingly depend on how well partners can anticipate challenges, maintain coherence across disciplines and communicate clearly with clients. Not every CDMO is equipped to do this. But those like Upperton that have invested in the resources to manage risk, will stand out in an inherently unpredictable industry.
The message is simple: Risk is a variable shaped by design, behaviour and environment. CDMOs that recognise this and embed risk mitigation into their operating models are the ones best positioned to support biotechs through the complexity of development and the pressures of commercialisation. And in a sector where timelines matter, budgets matter and patient outcomes matter most of all, that difference is invaluable.
Additional Resources
How to Evaluate CDMO Communication Before You Commit: A Framework for Biotechs
Communication becomes even more critical in today’s regulatory environment. The revision of Annex 1 has tightened sterile manufacturing guidelines, and long lead times make small batch production for early-phase trials harder to secure.
Upperton’s science-led, responsive approach helps clients navigate these complexities.
How to Secure a Successful Outsourcing Agreement
A Contract Development and Manufacturing Organisation (CDMO) contract is a formal agreement between a pharmaceutical company and a CDMO. This contract outlines the terms under which the CDMO will provide services such as drug development, manufacturing, and related support. Establishing a clear and comprehensive CDMO contract is essential for both parties to ensure mutual understanding and successful collaboration.
CDMO Services: Enhancing Drug Development and Manufacturing Efficiency
A Contract Development and Manufacturing organisation (CDMO) provides comprehensive services to pharmaceutical and biotechnology sectors. These services encompass the entire lifecycle of drug development and manufacturing, from initial research through to commercial production. By partnering with a CDMO, you can leverage their expertise and infrastructure, allowing you to focus on your core competencies.
