By Richard Johnson, Chief Scientific Officer, Upperton

When I first began my journey with Upperton more than 27 years ago, the role of a CDMO looked very different from what it has become today. At that time, the relationship between a sponsor and their outsourcing partner was largely transactional. A biotech company would approach us with a specific task, which would perhaps be a formulation challenge or a single manufacturing step. At this point, we would complete it, hand over the data, and move on. There was little integration, little strategic discussion, and little sense of shared ownership of the wider programme.

The Changing Needs of Biotechs

Undoubtedly, the landscape has shifted rapidly. As scientific complexity started to increase, sponsors realised that success depended on more than isolated operations. They needed partners who could understand the broader context, predict risks, and contribute meaningfully to development pathways. What I’ve witnessed since those early years is a transformation from CDMOs being a pair of hands to becoming genuine scientific collaborators. Today, we shape instructions in addition to giving them. We’re also involved far earlier. Before, CDMO support was often enlisted when a formulation was developed, whereas now we often work with a biotech before a formulation even exists. Our role has extended too, and we now guide decisions around manufacturability, scalability, enabling technologies, regulatory strategy, and the long-term viability of the drug product. This evolution has created more robust programmes, better scientific outcomes, and fewer painful surprises later in development.

Advancing Regulatory Environment

One of the most significant drivers of this change has been the advancing regulatory environment. In the past, quality planning was often back-loaded. You completed development and then wrote it all up. Frameworks like Quality by Design, risk-based development, Annex 1 revisions, and heightened scrutiny of data integrity have reshaped how programmes must be constructed. Since that time, quality and compliance has grown to become the architecture of a successful molecule. When we work with biotech partners today, we focus heavily on building that understanding early. We link formulation decisions to analytical needs, and analytical results to control strategies designed to stand up to the tests of every stage of the development journey from phase 1 through to commercial. This mindset has radically reduced late-stage setbacks and strengthened sponsor–regulator interactions. It also creates transparency, which in my experience is one of the most valuable currencies in drug development.

Advances in Molecule Design

Alongside regulatory evolution, the science itself has grown more challenging. Twenty-seven years ago, the majority of molecules we handled were small, relatively simple, and suitable for conventional oral solid dose. Today’s pipeline looks nothing like that. Many of the molecules emerging from discovery are highly potent, poorly soluble, unstable, or require enabling technologies like spray dried dispersions or lipid-based systems. Some need sterile processing under stringent aseptic controls. Others require integrated thinking across formulation, analytical method development, packaging, and delivery systems. This shift has required CDMOs to expand their capabilities and their scientific breadth. Similarly, it has led to a greater deal of outsourcing taking place as biotechs have a greater task in finding CDMO space that can accommodate the specific needs of their molecule. It has also demanded a higher level of internal collaboration. Process engineers, analytical scientists, formulation developers, quality specialists, and project managers cannot operate in silos. Each decision affects the next, and every discipline must understand the implications of the others. For CDMOs like Upperton, that operate on one-site, this feels like a natural evolution in cross-collaboration where more departments have the opportunity to work together. However, this has created challenges for CDMOs that operate across multiple locations.

Biotech Focus on Speed to market

Another major shift has been the increasing emphasis on speed-to-market. Investors, patients, and competitive pressures all demand faster progression from concept to clinic. But true speed does not come from rushing; it comes from anticipating. When CDMOs are involved early enough, we can eliminate the cycles of rework that historically plagued programmes. We design small-scale studies to generate scalable data. We build documentation that will serve both early and late phases. We spot manufacturability challenges while a molecule is still in preclinical development. By removing friction before it forms, we reduce delays, deviations, and therefore the chance of failed batches. I’ve seen programmes gain months simply by aligning scientific and operational reasoning from the outset.

Mature Project Leadership

A big enabler of this acceleration is mature project leadership. Project management today is a strategic function that understands the science, the regulatory expectations, the risks, and the operational nuances. They identify pinch points before they occur and ensure that sponsors have the visibility they need to make informed choices. In many ways, project management has become the backbone of the sponsor–CDMO relationship, the part that ensures the science flows smoothly and the communication stays open and honest. A key change that project management teams have needed to make is the implementation of a leadership figure that has overseen the changes of the industry. At Upperton, we include a member of our executive leadership team on every project, not as a figurehead, but as a member of the project team. Finally, I’ve watched supply chain resilience and sustainability emerge as defining responsibilities of modern CDMOs. The events of recent years exposed vulnerabilities in global sourcing, packaging, logistics, and material availability. Today, resilience is a critical part of programme success.

The Future of CDMOs

Looking ahead, I believe the future of CDMOs lies in even deeper integration. Development and manufacturing will continue to converge. Data will be shared in real time. Quality and risk management will be proactive rather than reactive. Sustainability will influence both design and execution. And partnerships will become more transparent, more honest, and more aligned than ever before. After 27 years, I can say confidently that the role of a CDMO is no longer to manufacture batches, it is to help innovators navigate complexity, reduce risk, and move more confidently from idea to impact.

If there is one lesson that encapsulates everything I’ve seen, it is this: the best outcomes happen when CDMOs and sponsors operate as true partners, united in purpose. That partnership, to me, is where the role of the CDMO is headed next.