The New Rules of CDMO Partnerships

With the rise of personalized treatments and increasingly more complex drug products on the market, the expectations placed on Contract Development and Manufacturing Organizations (CDMOs) are significantly increasing. With the global CDMO market projected to grow from $168 billion in 2025 to $318 billion by 2034, the demand for reliable, technically advanced, and comprehensive CDMO services is only likely to continue increasing in the coming years.

Pharmaceutical and biotech companies today are not just looking for R&D and manufacturing support. Sponsors today seek long-term development partners who can help to de-risk supply chains, accelerate time-to-market, and navigate an increasingly complex regulatory and geopolitical landscape. As CDMOs adapt to meet this demand, selecting the right long-term partner is a game changing advantage for every part of drug delivery from lab to commercial.

1. Deep, Trusted, Technical Expertise

At the core of any effective CDMO is its technical ability to translate molecules into stable, scalable, and commercially viable drug products. On top of that, clients need to know that their molecule is going to be taken care of and be a priority within the organization. If the final product fails to meet commercial or regulatory quality standards, it will ultimately lead to delays and high costs. Within CDMO partnerships, trusting the technical expertise and team developing your product is a fundamental element that cannot be compromised on.

Look for elements such as:

• Formulation development for a wide range of dosage forms including OSD, pulmonary, nasal and sterile.
• Senior SMEs assigned to all projects.
• Clearly established communication pathways with key decision makers.

From a client perspective, there is a need to be able to demonstrate the clear commercialization pathway for investors. Developing a long-term partnership with a CDMO and trusting their technical expertise to develop a plan for getting a project into the clinic and beyond is essential for any project.

Upperton CEO, Nikki Whitfield added that “Customers want more of a long-term partnership from their CDMOs instead of a transactional relationship. They want to know that the CDMO can help them solve problems and technical issues rapidly as they come along and support the client’s pathway to commercialization.”

2. Flexibility and Agility

Previous years have been shaped by endless capacity bottlenecks and demanded much greater operational agility from global CDMO’s. Sponsors are favoring flexible and agile CDMOs that can quickly adapt to challenges and work quickly to develop solutions.

When working with a CDMO that offers only partial services, or operates across several different sites, delays often occur as projects are passed from team to team as they advance through clinical trials. Many CDMO’s experience issues with this stage of product development.

Upperton’s unique approach to project management allows them to use the same Project Management team at every stage to avoid projects being passed around, thus preventing delays. This system of maintaining the same Project Management team also ensures faster turnaround times and deep understanding of projects within project teams. Each project has an assigned member of the Upperton Executive Leadership Team which are actively involved in projects, ensuring that SME experience is integrated into every project.

Upperton CEO, Nikki Whitfield said “At Upperton, we’ve built a strong reputation with our sponsors by being agile and offering a full end-to-end service on one site. Our setup certainly makes projects run more smoothly from a logistical standpoint but also enables our teams to cross-collaborate daily. Since our teams work together so often, that teamwork really shines through in the quality of our project work.”

3. Early CDMO Selection

Evaluating and selecting your CDMO partner early offers multiple benefits such as accelerated timelines, reduced costs through early access to CDMO expertise and mitigated risks related to process development and regulatory compliance.

Early partnership ensures that drug development projects are built on a solid foundation of trusted expertise, and less likely to run into issues later down the project timeline.

You should consider if your CDMO has:

• Efficient operational processes built into their business.
• Robust and thorough quality systems.
• Seamless scalability.

Early selection of a CDMO can be challenging due to the long processes needed to evaluate capabilities and technical expertise. As such, developing long term partnerships with a trusted CDMO can accelerate timelines and reduce costs of projects.

4. Risk Management

Recent geopolitical developments have highlighted the vulnerabilities of globalized supply chains. The pandemic, tariffs, and emerging new policies such as the PILLS act, Biosecure Act and revised Annex 1 guidelines have forced the industry to reconsider its dependence on overseas sourcing.

These policies aim to promote domestic drug manufacturing and reduce reliance on foreign suppliers adding new layers of complexity to global drug development and supply chains. This additional complexity means that CDMOs now play a crucial role in navigating complex regulatory pathways whilst also remaining agile enough to adjust timelines in a geopolitically volatile world.

Forward-thinking CDMOs are taking proactive steps to mitigate risk:

• Dual- and multi-sourcing strategies for critical materials.
• Domestic or reshored manufacturing capabilities.
• Expanded vendor qualification across stable regions.
• Digital supply chain monitoring and quality risk management.

Some organizations are using this moment to build strategic advantage, leveraging local infrastructure to offer more secure and efficient production pathways.

5. Industry Reputation

Ultimately, many elements factor into the industry reputation of a CDMO, which makes it a useful tool to evaluate the quality of service. As mentioned in the previous points, evaluating a CDMO’s reputation with regulatory bodies, the amount of small and large molecule projects they have worked on and the technical subject matter experts they employ is a strong indication of the way a CDMO can support your team.

You should consider if your CDMO:

• Has a strong track record with regulatory bodies for their reliability and compliance standards.
• Has a diverse project portfolio in a wide range of therapeutic areas.
• Has the infrastructure and expertise necessary to handle your project requirements.
• Can effectively mitigate risks.

A CDMO’s regulatory track record serves as a crucial benchmark for their reliability and compliance standards. This regulatory credibility becomes particularly valuable when navigating complex approval processes across multiple jurisdictions, as experienced CDMOs can anticipate potential regulatory challenges and proactively address them.

The breadth and depth of a CDMO’s project portfolio also reveals important insights about their capabilities and capacity. A diverse range of completed projects across various therapeutic areas indicates not only technical versatility but also the ability to adapt methodologies and processes to meet unique client requirements. Finally, examining the complexity and scale of previous projects can help determine whether the CDMO has the infrastructure and expertise necessary to handle your specific development needs. In summary, selecting a CDMO is a long and difficult process, with several factors needing to be considered before finalizing selection. Sponsors should consider the technical expertise available at the CDMO, how much they trust them, the flexibility and agility of their processes, in addition to the way risk is managed across their operating processes.