“CDMOs will tell you yes, yes, yes. But when you get to it, there can be a lot more no’s than yes’s in the day-to-day operation of running a manufacturing campaign.”
Bobby Zubis is Senior Director of Strategic Operations at Resolution Therapeutics, a clinical-stage biotech pioneering regenerative macrophage therapy for inflammatory and fibrotic diseases. He spoke with PharmaSource at the Advanced Therapies Congress in London in March 2026.
In this interview, Bobby draws on his direct experience of navigating the cell therapy CDMO market — including hard lessons from previous CDMO selections — to lay out what a more rigorous evaluation process looks like in practice.
Resolution Therapeutics is working in a disease area where there are currently no approved therapeutic options. Their lead program targets end-stage liver disease using regenerative macrophages — a cell type that has not previously been developed as a disease-modifying agent. It is a novel approach, which means the manufacturing challenges can be equally novel, increasing the importance of selecting the right CDMO partner.
The Gap Between What CDMOs Promise and What They Deliver
Early investor enthusiasm in cell therapy drove rapid capacity expansion in the CDMO market. When the funding environment tightened and several clinical programs stalled or failed to reach approval, CDMOs found themselves competing harder for a smaller pool of clients. The commercial pressure that creates has effected on how they present themselves during the selection process.
“Cell therapy has gone through a cycle,” Bobby explains. “It was the beloved child of the biotech scene. It had a lot of promise. And where investors aren’t investing, the money’s not going. So in that starvation space, CDMOs will often, when you’re having a pitch with them, tell you yes, yes, yes.”
The problem is that early-stage biotechs — especially those entering cell therapy manufacturing for the first time — may lack the experience to pressure-test those commitments. They take the pitch at face value, and the gaps only become apparent once a manufacturing campaign is underway.
Based on his experience contracting CDMOs, Bobby has learned the hard way what can be missed: whether the CDMO had the staff headcount to actually deliver on the capacity they had agreed, whether the experience on the ground matched what was presented in the pitch, and whether there was any contractual mechanism to hold the CDMO accountable if they underperformed.
“Do they have the FTEs to deliver the promise of whatever capacity you’ve decided with them? Do they have the experience at the right level?”
Building a Rigorous Selection Framework
Selecting a new CDMO for late phase development, and the process they have built is substantially more structured process. Such processes are a direct product of his own lessons learned — such as building a cross-functional matrix team working through a documented framework that seeks to address knowledge gaps.
The process moves through three stages. An initial RFI filters for basic capability. An RFP and follow-on conversations allow for a more detailed assessment. The critical stage is the technical site visit, where the full team goes on-site and works through the details in person.
“A site visit is where you bring the entire team over, and you probe holes, kick tires, chew fat. You really go to town and try to find out where the skeletons are. You never really know until you go to the site.”
How to Read the CDMO Market: Big Players, Middle Ground, and Where Risk Hides
One of the more practical contributions Bobby makes is a clear-eyed assessment of where different CDMOs sit in the cell therapy market and what that means for an early-stage biotech evaluating their options.
The largest CDMOs — those with commercial-stage cell therapy assets already running through their facilities — offer the highest level of assurance, but come with trade-offs in availability and flexibility. At the other end, very early-stage CDMOs may lack the experience needed for a pivotal-phase program where execution risk is high and every patient matters.
The most complicated group is the middle: CDMOs that have handled mid- to late-stage assets but have not yet taken a product through to approval, often because a leading client program failed at the regulatory stage.
“There’s a slew of people who are in that middle ground. They’re quite well-developed. They’ve only done some mid- to late-stage assets and never got through to commercial. Maybe their leading client fell through and didn’t get FDA approval. So it’s been a mixed bag.”
This middle group is where CDMO consolidation is having the most visible effect. Larger organizations are acquiring smaller specialists to add capabilities, which means a CDMO that looks mid-tier on paper may have recently acquired deep expertise in a specific cell type or manufacturing process. Verifying what has actually been integrated — versus what has simply been acquired on paper — is part of the due diligence work.
Bobby is broadly positive about consolidation, with one important caveat. A CDMO that presents as a one-stop shop but subcontracts key steps introduces handoff risk that requires some serious thought, particularly for cell therapy players.
“When you’re a cell therapy manufacturer and looking at the US, for example, you want to own all of those links in the chain. You want to have direct responsibility and relationships with each of them. So it’s a bit of a double-edged sword.”
Cost of Manufacture and the Risk-Sharing Conversation CDMOs Avoid
Manufacturing cost is one of the most persistent structural challenges in cell therapy, and it is one that Bobby does not shy away from. Resolution has set ambitious cost-of-manufacture targets that they need to hit by the pivotal and commercial stages. Investment in automation is one way this can be achieved, but it is not clear yet who will bear the cost.
“It’s a question of who’s going to make the investment in automation. CDMOs don’t want to, potentially, because it’s a risk. They invest, and you don’t continue with them. They’ve made a huge investment with no revenue to return that investment.”
His broader ask of CDMOs is one of transparency. He would like CDMOs to be willing to share their margin structure openly, at least at the point where a contract is close to being signed. Biotechs need to know they are getting a fair price, and CDMOs need to know that the biotech’s cost targets are realistic. Without that information on both sides, neither party can assess whether the partnership is actually viable.
“I’m not immune to the fact that not everyone wants to share what their gross margin is. But when there’s only one player in the game, and you’re about to sign, it’s good to have that transparency. It just helps with the relationship.”
Lessons Learnt
What Bobby’s account makes clear is that the cell therapy CDMO market is still maturing, and that the information asymmetry between CDMOs eager to win work and biotechs without deep manufacturing experience remains a real risk for early-stage programs. The answer is to build an evaluation process that compensates for what you cannot verify from a pitch deck.
Resolution’s decision to systematically document their lessons learned and build a new selection framework from them is the kind of institutional discipline that early-stage biotechs rarely have time for, but that pays off directly in manufacturing execution. As Bobby puts it, choosing a CDMO for a pivotal study is a long-game decision: they are likely to become your commercial manufacturing partner. The due diligence has to match the stakes.
