In the first three posts in this series, we covered the manufacturing landscape for advanced therapies, the importance of modality-specific expertise and development integration, and the process philosophy and infrastructure criteria that distinguish the strongest CDMO partners. This final post turns to the two remaining dimensions: the partnership model and the evaluation questions that surface what formal presentations rarely do.
These are the criteria that are most difficult to assess from a capability document and most important to get right. Capability infrastructure can be described on a slide. Partnership quality is revealed through conversation, behavior, and the character of the answers a CDMO gives when questions become specific.
1. Partnership Model: What Working Together Actually Looks Like
Beyond capabilities and infrastructure, the character of a CDMO partnership significantly influences program outcomes. The difference between a partner who executes what you specify and a partner who brings a scientific perspective to every program decision is not marginal. In advanced therapy development, where the science is complex and the challenges are real, that difference shows up in how quickly problems are identified, how reliably manufacturing runs go, and how confidently you can respond to regulatory inquiries.
The most productive CDMO relationships share a set of structural characteristics that are worth looking for explicitly during the evaluation:
Characteristics of a High-Quality CDMO Partnership
- The CDMO brings scientific perspective to program decisions, offering clear recommendations, identifying tradeoffs, and sharing the reasoning behind their approach.
- You have direct access to the scientists running your program, not just project managers or account leads.
- Communication is proactive: the CDMO surfaces questions and concerns before they become problems, not after.
- The engagement model is flexible enough to support your program wherever you are: first-time process development, IND preparation, or GMP scale-up.
- Program team continuity: the scientists you meet during evaluation are the scientists who would work on your program.
That last point deserves emphasis. In the evaluation process, you will spend time with scientists who are enthusiastic, knowledgeable, and engaged. The question worth asking explicitly is whether those individuals would be assigned to your program or whether a different team takes over once the contract is signed. This happens more often than program leaders expect, and it is worth surfacing directly.
"Ask to speak directly with the scientists who would be assigned to your program. The depth and quality of that conversation is often the most informative part of the evaluation."
2. Evaluating Partnership Quality Before the Contract
Partnership quality is not observable from a capability presentation, but it is observable from how a CDMO engages during the evaluation. Pay attention to the following:
How do they handle hard questions? A partner who responds to difficult technical questions with specificity and candor, including acknowledgment of the limits of their experience, is demonstrating the communication style that you will depend on when challenges arise. Deflection or vague reassurance is a signal.
How do they approach disagreement? Ask them directly: How does your team handle a situation in which the scientifically preferred path differs from the sponsor's initial direction? The answer reveals their willingness to advocate for the science, their communication style under tension, and whether they operate as a genuine partner or as a service provider.
How do they describe the programs that did not go perfectly? Every experienced CDMO has worked through programs with technical challenges. The way they describe those experiences, whether they engage them with honesty, reflect on what they learned, and explain how their approach changed, tells you about their organizational culture. Reluctance to acknowledge past challenges is worth noting.
3. The Questions That Reveal What a Capability Presentation Cannot
The following questions are consistently useful across CDMO evaluations, regardless of modality or program stage. They are designed to surface scientific depth, process maturity, and organizational culture in ways that formal presentations rarely do. Use them as conversation starters; the goal is not a scripted answer, but a genuine exchange that reveals how the team thinks.
On Scientific Depth and Program Experience
"Share an example of a technically complex program your team has worked through. What made it challenging, and what did the team learn from it?"
This question works because it invites the CDMO to speak from experience. Specificity, candor, and reflection are good signs. Generic answers about embracing complexity or experienced teams are not. Listen for the scientific content of the answer, whether the challenge described is genuinely technical, whether the team's response demonstrates analytical rigor, and whether there is a clear through-line from challenge to learning to practice change.
On Process Development Philosophy
"At what stage do you typically define critical process parameters, and what does that process look like in practice?"
The right answer here is early. CPP definition during the RUO stage is a hallmark of a development-forward philosophy. If the CDMO describes the CPP definition as part of the GMP process itself or as occurring during technology transfer, that is a signal of their development approach.
On Technology Transfer and Transparency
"Walk us through your technology transfer process. What does the sponsor see at each stage, and where are the key decision points?"
This question reveals two things: the operational maturity of the CDMO's transfer process, and their transparency model with sponsors. A CDMO with a well-structured technology transfer will clearly describe it, identify decision points, and explain how sponsor visibility is maintained throughout. One that describes technology transfer as primarily a documentation exercise may be less oriented toward partnership.
On Problem-Solving and Root Cause Analysis
"How does your team approach process investigation and root cause analysis when a manufacturing run does not go as expected?"
Manufacturing challenges happen. The question is how a CDMO responds when they do. Look for a structured approach: clear escalation paths, defined investigation protocols, and a culture of rigorous root cause analysis rather than anecdotal troubleshooting. Ask for a specific example. The process by which a team works through a difficult run tells you as much about their capabilities as a perfectly executed run.
On FDA Engagement and Regulatory Depth
"What has your FDA engagement on programs in this modality looked like, and how has that feedback shaped your approach?"
CDMOs with genuine regulatory depth have a track record of FDA engagement that they can speak to specifically: pre-IND meetings, design review meetings, and responses to CRL questions. They also have a clear view of how that engagement has informed their development and manufacturing approach. This is not a common capability; a CDMO that can speak to it with specificity has earned a meaningful differentiator.
4. Choosing the Partner That Fits Your Program
The strongest CDMO partnerships share a consistent set of characteristics: genuine modality expertise, seamless integration across development and manufacturing, a process philosophy built for clinical execution from the start, and a collaborative approach that makes your team more capable throughout the engagement.
Programs that move efficiently from development to clinic do so because their manufacturing partner understands the science, anticipates the complexity, and brings the experience to execute reliably at every stage. A capability presentation can describe these qualities. The evaluation process is how you find out whether they are real.
Use the questions in this guide and the criteria across all four parts of this series to build an evaluation process that surfaces what you need to know. Ask for program-specific examples. Request time with the scientists, not just the project leads. Push on the hard questions. And pay attention not just to what a CDMO says, but to how they engage.
The CDMO right for your program will demonstrate this throughout the evaluation. The one that is not will, too.
About Landmark Bio
Landmark Bio was purpose-built to be exactly the kind of partner this series describes. From early process development through GMP manufacturing, QC, and IND-enabling CMC support, Landmark's integrated team draws on deep drug development expertise across process development, analytical science, quality, and regulatory affairs, working as a true extension of your organization at every stage of the program.
Landmark operates a 44,000 sq ft purpose-built facility in Watertown, MA, with 14,000 sq ft of ISO 7 and ISO 8 GMP cleanroom space across 9 suites, supporting cell therapy, viral vector, and complex cell system programs, including stem cells and CAR-T. The team has completed an FDA Design Review Meeting and has a track record of successful sponsor audits for GMP manufacturing and release testing.
COMING NEXT IN THIS SERIES
Coming Soon: The Full CDMO Selection Guide
The complete four-part series, expanded with a frequently asked questions section and a decision framework, is being released as a downloadable eBook. Reach out to contact@landmarkbio.com to request early access.
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