CDMO Selection Beyond Capabilities And Price
By Matthias Gerlach, Ph.D., independent executive advisor in pharma and biotech
Selecting a CDMO is a decision I have faced from both sides and at various inflection points, including during development, through technology transfer and scale-up, and later in commercial manufacturing and supply. In each one of these scenarios, assessment begins at determining technical fit. The site needs the right technology, equipment, and regulatory experience for the product and its stage of development. Assessing technical fit can be fairly simple and covered in a slide deck presentation; however, it is only the beginning.
Some of the most useful information in a selection decision is also the hardest to obtain and requires the CDMO to show all of its cards. Evidence from comparable programs gives a clearer view of delivery reliability. We want a picture of how teams will perform once the contract is signed, and especially how they will respond to and report issues. Those considerations become sharper as a program moves toward validation and commercial supply. Decisions at the CDMO can affect regulatory commitments, product availability, and the sponsor’s planning.
My approach to selection therefore draws on execution history, the people behind the proposal, and the way the organization works under pressure.
Requests for information (RFIs) and requests for proposals (RFPs), supported by technical and quality assessments, establish whether a supplier can meet the basic requirements. Often, more than one candidate will present a credible technical case, and sponsors must decide between them. At that point, I look for comparable experience, a robust technology-transfer record, and a realistic manufacturing plan.
CDMO selection is a cross-functional risk decision. Different functions bring different concerns to the assessment, including development feasibility, quality oversight, and operational execution. The selection process should bring those perspectives together around the needs and risks of the specific product.
1. Start With Relevant Experience
The site must be technically capable of performing the work. In my assessment, evidence that the capability has been applied in a relevant setting provides a firmer basis for judging execution risk. A CDMO that has transferred a comparable process or manufactured a similar dosage form at the required scale brings useful operational context to the discussion.
I also look ahead. A development solution may require another technology transfer when the program reaches validation or commercial scale. That can be entirely reasonable when the next handoff is visible early and included in the initial plan. My preference is to understand the likely manufacturing path before the first transfer begins.
Relevant experience needs to reflect the setting in which the work will be done. Development stage, scale, and regulatory context all influence how useful a CDMO’s operational history is for the program at hand.
2. Assess The People Who Will Run The Program
Sponsors select a company, but they work day to day with a relatively small group of people. In my experience, the team presented during selection deserves close attention. The technical lead, project manager, and quality representative are likely to shape the program long after the business-development phase has ended.
I pay close attention to how a team handles uncertainty. Early identification of a genuine technical concern, followed by a clear plan to resolve it, gives me confidence in the team. A candid discussion of uncertainty is often a good indication that the team understands the technical risk behind the timeline.
During the introduction phase, sponsors should spend time developing a business continuity plan. I have seen technical knowledge lost during a transfer or validation program creating delays that are difficult to recover from. Sponsors benefit from understanding who will carry the program forward after the contract is signed and how knowledge will be retained if key personnel change.
3. Look For Transparency Before You Need It
One signal I watch closely is how quickly a CDMO communicates emerging problems. Development and manufacturing problems are unavoidable. An analytical result may require investigation, a raw material may arrive late, or a manufacturing campaign may move. In my experience, these situations can usually be managed when they become visible early enough.
A more difficult situation arises when an issue has been discussed internally for days or weeks before the sponsor is informed. At that point, the technical problem may still be manageable, while options elsewhere in the program have already narrowed.
References and prior sponsor experience can provide useful evidence before selection. I find references most valuable when the discussion goes beyond confirming technical capability. I ask for specific examples: How did the CDMO respond when a technical problem emerged? How early was the sponsor informed? Was the impact communicated realistically? And did the team bring practical options for resolving the issue? Where possible, I also look for references from programs at a comparable development stage, technology, and scale. These conversations can provide useful insight into how a CDMO behaves when execution becomes difficult.
4. Evaluate Governance Before The Project Starts
Before work begins, I want decision ownership, escalation routes, and meeting cadence to be clear. These arrangements determine how quickly the two organizations can act when an issue emerges.
Clear decision rights have helped teams resolve difficult issues quickly and keep manageable problems from consuming time unnecessarily. Good governance gives both organizations a practical way to work through problems and protect the project timeline.
The operating model should establish how technical decisions will be made, when senior management will become involved, and how the parties will handle disagreement. In my experience, agreement up front makes day-to-day collaboration more effective when a serious problem arises.
5. Select For The Relationship Ahead
A CDMO relationship may span development, validation, and commercial supply. The sponsor’s needs will change along the way, and the supplier may change as well. Factors such as capacity and team changes can influence how relevant the sponsor's specific program remains in their CDMO's portfolio.
I therefore look at how the proposed relationship could evolve with the program. A supplier may be well suited to an early clinical program and remain a strong partner through commercialization. In other cases, a change of site or provider will be the sensible next step. Both paths can work when they are recognized early and planned accordingly.
I consider the commercial proposal in the context of execution risk and the work's expected life cycle. Delays can outweigh an initial price difference quickly. The commercial comparison is most useful when it reflects the full scope and duration of the expected work.
Structured Evidence Supports Qualitative Assessment
Comparability is critical when using performance data in CDMO selection. A benchmark only becomes useful when the context is clear. Development stage, technology, scale, and regulatory setting all influence what good performance looks like. In my experience, the most useful benchmarks compare operations serving a similar need rather than relying on broad industry averages.
This is where better decision support can help. Independently verified evidence on execution and quality performance can reduce uncertainty when interpreted within a relevant peer group. References, audits, and previous sponsor relationships remain useful inputs. Broader evidence gives those inputs additional context.
Experienced judgment remains part of the selection. I have found that structured evidence helps make qualitative factors easier to assess while leaving room for the judgment that a complex supplier decision requires.
Choose Partners For Predictability
After many years of working with CROs, CMOs, and CDMOs, predictability has become one of the qualities I value most in an external partner. Problems occur in pharmaceutical development and manufacturing. I look closely at how early they become visible, how realistically their impact is assessed, and how quickly the two organizations can decide what to do next.
Technical capability, capacity, and commercial terms remain central to the selection process. It's important to examine execution history, team continuity, and behavior under pressure with equal care. These factors are harder to capture in an RFP, yet they shape the daily reality of the relationship.
The CDMO relationships that have worked best for me were built on early visibility, candid discussion, and clear decision-making. That is the kind of operating environment I would look for before committing a critical program.
About The Author:
Matthias Gerlach, Ph.D., is an independent executive advisor with more than 25 years of experience in the pharmaceutical and biotech industry. His background spans drug discovery, CMC (chemistry, manufacturing, and controls), pharmaceutical development, technology transfer, external manufacturing, global supply chain, and commercialization. He most recently served as managing director and SVP of manufacturing and supply chain at Aeterna Zentaris GmbH in Germany. He has worked with international CROs and CDMOs across multiple development stages and modalities and currently supports biotech companies and industry partners on CMC, manufacturing, supplier strategy, and operational execution.