Over time, drug development has become more complex due to increased scientific understanding, more complex therapies and the rise of new technologies. Regulatory pathways and tech transfer have also been made more challenging with changes to the geopolitical landscape.
For CDMOs and biotechs working to these new market conditions, the increase in complexity creates additional challenges and opportunities. Now, a CDMO acts as a strategic extension of a biotech as opposed to a transactional contractor. One outcome from this is that choosing the right CDMO becomes more difficult.
Whilst there are a multitude of choices involved in selecting a CDMO partner, does the physical location of a CDMO become part of the selection criteria? And are there any benefits that come with a one-site CDMO?
What Is a One-Site CDMO?
Put simply, a one-site CDMO is a CDMO where GMP, R&D and manufacturing all operate on one site. Logistically, this makes moving projects from team to team more streamlined, because the teams are familiar with working together and operate in one space.
In contrast, many CDMOs struggle to find space large enough to house their entire operation and, upon expansion, need to acquire space further away from their original operation. These sites are referred to as Global or multi-site CDMOs.
Whilst all sites are capable of providing a comprehensive CDMO service, there are several benefits for small to medium sized attached to working with a one-site CDMO.
Key Considerations For a One-Site CDMO
Choosing a one-site CDMO model can make a significant difference in how smoothly and efficiently a project progresses. With all teams under one roof, communication becomes faster and more direct. Decisions are made quickly, and delays caused by cross-site coordination are virtually eliminated.
Tech transfer is another area where the one-site approach shines. There’s no need to ship materials or documents between locations, and R&D and manufacturing teams can collaborate in real time to troubleshoot and optimise processes. This close-knit setup helps compress timelines, making it easier to move from development to GMP batch manufacture and ultimately reach the clinic or market faster.
Quality oversight also benefits from this integrated model, leading to seamless scalability. Unified systems and documentation ensure consistency, simplify compliance, and make audit preparation more straightforward. For sponsors, the ability to visit a single site for updates, batch manufacture, and meetings builds trust and transparency, which strengthens the partnership and keeps everyone aligned.
Another key consideration is that one-site CDMOs are typically more tailored to small to medium sized biotechs due to the size of the facility. Large clients may find themselves limited by the physical size of the facility and may need to enlist a multi-site CDMO to accommodate the size of the project.
Key Consideration for a Multi-Site/Global CDMO
Multi-site or global CDMOs operate with facilities spread across multiple locations, sometimes within the same region, and sometimes across different countries. This structure can offer advantages for large-scale projects, as these sites typically have greater physical capacity to handle scale-up from clinical to commercial volumes. However, this benefit comes with trade-offs. Tech transfer between sites can be more costly and time-consuming because materials, documentation, and sometimes equipment need to be shipped, adding logistical complexity and potential delays.
Another consideration is client prioritisation. Large, global CDMOs often focus on high-volume projects, which means smaller, or mid-sized biotech companies may find themselves competing for resources and timelines. This can lead to longer lead times or less flexibility for emerging biotechs, but could be a potential benefit for larger companies.
Project management is also a key differentiator. Multi-site CDMOs tend to have more complex project team structures, requiring clients to navigate multiple contact points across different locations. While this can provide specialised expertise, it often introduces additional layers of communication and coordination, which can slow decision-making and complicate issue resolution.
Key Consideration for a Multi-Site/Global CDMO
One-Site CDMO
Multi-Site / Global CDMO
Tech Transfer
Facilitated by close proximity of teams, making handovers smoother and simpler.
More processes due to shipping of documents and handovers over multiple sites.
Scalability
Seamless scalability due to the fast transition between different parts of the site.
Greater capacity for scaling tailored towards large commercial volumes, albeit on longer timelines for transferring between sites.
Project Management
One key point of contact who is dedicated to your project from start to finish.
Multiple contact points for each project stage.
Client Focus
More personalised for small to medium biotech.
Tailored to large clients, which are often prioritised over smaller projects.
Additional Resources
Choosing the right CDMO partner is a critical decision in drug development. The collaboration between pharmaceutical companies and contract development and manufacturing organisations (CDMOs) provides access to specialised expertise and manufacturing services.
Learn more about how pharmaceutical companies should select the right CDMO for their needs.
Outsourcing to Contract Development and Manufacturing Organisations (CDMOs) has become a strategic approach to enhance efficiency and reduce costs. By partnering with a CDMO, you can leverage specialised expertise and resources, allowing your company to focus on core competencies such as research and development.
Learn more about CDMO Outsourcing.
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.
Learn more about CDMO Contracts.
