If there’s one constant in drug development today, it’s that the pressure of speed to clinic is only ever increasing. The sheer growth of small biotechs and mid‑sized pharma companies entering the field has reshaped expectations of Contract Development and Manufacturing Organisations (CDMOs). Over the past decade, 32% of innovative drug approvals were sponsored by emerging biotech companies, suggesting that they are more willing and more able to take on the risks of innovation than big pharma. To do this, biotech teams need to be lean but ambitious, their molecules promising yet complex, and their timelines ambitious.

“Flexibility and agility are everything. Biotechs need CDMOs to be nimble on their feet, to think creatively, and to truly act as an extension of their team.”

The key elements are to build the culture, capability, and processes for fast, collaborative problem-solving, especially in the middle of early development where unknowns inevitably emerge. The reality is that projects fail, or succeed, in how quickly challenges are solved together.

Biotech Strategies Have Evolved and CDMOs Must Evolve With Them

Over the past ten years, there has been a real shift in the way products are developed by biotechs. Years ago, it was quick to clinic, demonstrate that the desired clinical exposure is visible, and the product would then be sold off as an asset. However, that isn’t the case anymore. Biotechs now have a vision of going right from early-stage development all the way through to late stage. Therefore, when biotechs are going through CDMO selection, they want to know that they’re going to work with a team that can deliver it all the way through.

“Biotechs now want partners who can deliver from the very early days through to late development. We share that vision, and we plan for it from the start. Quick to clinic matters, but quick to clinic with a path to scale matters more. CDMOs need to help map that path, so momentum doesn’t stall after the first study.”

That changes how programmes are designed. It isn’t enough to solely target Phase I; CDMOs need to build for scalability. Early on, there needs to be a plan for manufacturability, process trains that can expand, and decisions that won’t become bottlenecks later.

“For Upperton, that’s the most inspiring part of the work: seeing teams bring their science to patients and knowing we helped along that journey.”

What Partnership Looks Like in Practice

In a typical scenario, a biotech team arrives with a promising molecule and an aggressive timeline to first-in-human. The science is strong, the formulation window is tight, and the delivery route is challenging.

CDMOs then convene a cross functional team, R&D formulators, analytical scientists, GMP manufacturing leads, and regulatory specialists. From day one, a senior leader joins the core project team, not for optics but for speed and unparalleled decision-making experience.

Early meetings should focus on a simple question: What will break if we’re wrong? This needs to be followed by pressure‑testing excipient choices against GMP versions, aligning analytical methods with release needs, and mapping the technical batch to flush out hidden risks. Manufacturing highlights equipment nuances that R&D folds into process development. Regulatory flags potential pitfalls that we address before they become show‑stoppers.

“By the time we hit the technical batch, it feels like muscle memory. Everyone knows the plan, the handoffs, and the failure modes we’ve already mitigated.”

The clinical run then becomes execution, not experimentation. And because we made Phase I decisions with Phase II/III in mind, the scale‑up conversation starts clean, with fewer re‑engineering cycles and less risk of revalidation.

Where Projects Win or Lose: R&D to GMP Transition

One critical moment where drug development consistently gets riskier, is the transfer from R&D into GMP manufacturing.

“As a formulator by heart, I’ve seen firsthand how easy it is for knowledge to evaporate when departments operate in silos. When R&D and GMP don’t move as one, knowledge gets lost, timelines slip, and risk creeps into the clinical product.”

CDMO Selection as a Critical Business Choice

Early phase development is full of challenges, and biotechs need to be able to trust that their CDMO team is going to be able to respond quickly, come up with ideas enthusiastically and be able to navigate the shift to the clinic and beyond. Whilst choosing a partner that has specialised capability and experts is undeniably important, looking beyond that to the wider capabilities of the business are equally as important.

The CDMO is the team that is going to take a project all the way to market. They will provide support throughout all the highs and lows of early and late phase development and manufacturing. The precise expertise needed will need to pivot and change as the project develops. Therefore, building a positive relationship with the whole CDMO organisation is essential.

“The advice that I would give is pick a team where you feel like you’re a high priority in the organisation, where you get to know the leadership team, and have a very technical project team that is also enthusiastic and passionate about your product.”

Final Thoughts

The CDMO market is crowded and capable, but capability alone doesn’t guarantee outcomes. What matters, especially for smaller biotechs and midsized pharma, is a partner who can move quickly, think critically and creatively, and collaborate deeply.