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Outsourcing to a contract development and manufacturing organization (CDMO) is a critical step for many biotech companies aiming to advance their programs without building costly internal infrastructure. But while biotech CDMOs can provide essential expertise, capacity, and regulatory support, choosing the right partner is rarely straightforward.
Beyond technical capabilities, biotechs must weigh factors like project fit, communication style, flexibility, and long-term alignment. A mismatch can lead to costly delays, quality issues, or even failed programs.
In this article, we explore the key criteria biotech companies should consider when selecting a CDMO and how to avoid common pitfalls, based on expert insights and real-world experience.
Table of contents
Know what you need
Choosing the right CDMO starts with a clear understanding of your project’s specific needs and with recognizing that there is no universal “best” CDMO, only the best fit for your particular case. Biotech companies must define key parameters early, including the development phase. “A CDMO that excels in early R&D (research and development) batches may not be well-suited for commercial GMP (good manufacturing practice) production. Pick a partner that’s in sync with your stage,” advised Michael Bush, chief executive officer (CEO) of GrowthWays Partners.
The type of molecule involved should also affect your choice — whether small molecule, biologic, or advanced modality like cell or gene therapy, and the level of technical complexity expected.
“A common mismatch that carries heavy consequences is a lack of alignment between the required modality, or phase of development that the CDMO has experience in, and the client requires. Any incongruencies here can lead to unexpected delays, regulatory setbacks, and costly rework projects,” said Bev Cameron, sales director, Europe and APAC at Aldevron.
Several experts emphasized that success often hinges less on finding a CDMO with impressive capabilities on paper, and more on finding a partner whose strengths align with the biotech’s goals. As Paul Shapiro, CEO of The Better Meat, a company that has recently been through the process of choosing a CDMO, puts it: “Fit goes beyond capabilities, it’s about alignment. We looked at a CDMO’s experience with biomass fermentation, their scale-up track record, and most importantly, their willingness to collaborate on novel processes. A good fit means they’re not just executing, they’re problem-solving alongside you.”
This idea of complementarity rather than pure execution is particularly important for biotech companies handling novel modalities or navigating early-stage development challenges. As Amy Hay from CTMC explained, identifying a “fit-for-purpose” partner requires a biotech company to first assess its own strengths and weaknesses, and then seek a CDMO that can fill the gaps efficiently. Depending on priorities, this could mean looking for a partner capable of expansive support across development and regulatory hurdles, or one closely aligned with clinical networks to speed up patient enrollment and trial execution.
In practice, this early self-assessment helps biotech companies avoid one of the most common pitfalls: choosing a CDMO based on reputation alone rather than project-specific needs.
Evaluate the CDMO’s technical expertise and regulatory capabilities
Once the project’s scope is clear, the next step is to assess whether a CDMO has the technical and regulatory expertise needed to deliver on it. In the early stages of selection, companies often focus heavily on technical proficiency, but as several experts emphasized, it is just as critical to evaluate regulatory rigor from the outset, especially when dealing with novel or complex modalities.
Experience in the relevant therapeutic area or with similar types of products can make a significant difference. As Michael Franco from PSG Biotech pointed out, biotechs should not only check general capabilities but make sure that “the CDMO has experience in your specific therapeutic area or with similar products.” Technical competence needs to be practical and proven, not just theoretical expertise.
Elizabeth Hickman, CEO of AustinPx, a CDMO based in the U.S., confirms that the CDMO’s technical capability is the most obvious criterion to consider for a reason, it is essential. “Biotechs need to assess the CDMO’s experience and expertise — does its technology and experience match what is needed for the project? Do they have the proper systems and infrastructure in place to ensure the project is successful? In the earliest phases, new information develops quickly — can the CDMO respond quickly and provide guidance on paths forward when challenges present themselves?
Regulatory strength is just as important. Hay stressed that regulatory diligence must be embedded early into development, not left as a late-stage concern. She explained that failures to integrate chemistry, manufacturing, and controls (CMC) rigorously from the beginning have delayed promising therapies at the U.S. Food and Drug Administration (FDA) approval stage.
One way to anticipate success is to understand how closely the CDMO’s regulatory experts are involved in day-to-day technical decision-making. According to Hay, a strong signal of quality is when “the CDMO includes their regulatory lead in core team meetings,” ensuring that development choices are aligned with evolving regulatory expectations rather than corrected after mistakes emerge.
Other experts echoed the need to dig deeper when assessing technical and regulatory capabilities. Instead of relying solely on high-level promises, companies are encouraged to ask for detailed examples: past projects, yield performances, timelines, regulatory interactions, and even examples of course corrections during development.
“Start by seeking references and case studies in the field from other clients working with the CDMO on similar modalities. Look out for whitepapers, co-marketing materials, or public presentations that demonstrate a CDMO’s experience and success in your area of interest,” said Cameron.
A CDMO’s willingness to share comprehensive case studies or regulatory track records is often a reliable indicator of transparency and maturity.
In the end, evaluating technical and regulatory strength is not just about capacity — it’s about de-risking the journey ahead. A capable, proactive CDMO will act as a true partner in anticipating challenges, navigating regulations, and ensuring that technical execution and compliance move hand in hand.
Communication and culture alignment
Beyond technical expertise, the strength of the relationship between a biotech and its CDMO often determines how smoothly a project advances. A good CDMO should feel like an extension of the biotech team, with open communication and a shared sense of ownership over the program’s success.
Cameron emphasized that good communication starts with responsiveness and full transparency. “It starts with having the right experts involved to support any inquiries you might have, and continues with timely responses and full transparency — especially when challenges arise,” she explained. Regular meetings, clear milestone tracking, and detailed progress reports are hallmarks of a reliable CDMO. By contrast, Cameron warned that “delayed or vague responses, a lack of strategic engagement, and minimal visibility into deliverables and project timelines” are red flags that should not be ignored.
From the perspective of companies that have gone through the CDMO selection process, early issue flagging also emerged as a critical marker of good communication. “You want partners who flag issues early, not just report problems after the fact,” said Shapiro. Defensiveness or slow response times, he added, often reveal deeper dysfunctions within the CDMO’s operations.
Hay also pointed out that establishing a clear governance structure from the beginning is one of the best safeguards against miscommunication. “Good communication starts by having a clearly understood governance structure that supports clear, transparent communication at the right levels,” she noted. In her experience, partnerships that maintain a higher-level steering committee for strategic oversight, combined with dedicated teams for day-to-day exchanges, are better able to stay aligned and resolve issues before they escalate.
Across all these insights, one common thread emerges: communication is not just about answering emails or providing updates — it is about building a framework where transparency, speed, and collaboration are deeply embedded in the way both teams operate. Without it, even the most promising technical programs can lose momentum.
Choose a flexible CDMO
A CDMO’s ability to handle the immediate project scope is important, but scalability and adaptability are equally crucial, especially for biotech companies aiming to move quickly from early development to clinical or even commercial stages.
Franco underlined that scalability should be a core technical consideration during CDMO selection. “One of the most critical technical considerations is whether a CDMO can effectively scale production from small-scale clinical trials to large-scale commercial manufacturing.” Franco advised biotech companies to specifically look for CDMOs equipped with manufacturing systems that allow high turn-down ratios — the ability to operate efficiently across a wide range of capacities — to minimize disruption during scale-up.
Adaptability to changing project needs is another key factor. “Biotechs should assess how flexible a CDMO is in accommodating evolving project requirements,” Franco added. This means understanding whether the CDMO can modify processes, adjust timelines, or reconfigure equipment setups as a project develops. Facilities that can pivot between customized and standard configurations are often better suited to the unpredictable nature of biotech programs.
Capacity management is also about resilience. Franco encouraged companies to ask about a CDMO’s supply chain robustness and redundancy plans: “Evaluate whether a CDMO has sufficient capacity for your project. Ask about their supply chain resilience, redundant manufacturing capabilities, and capacity management approaches to ensure your production won’t face interruptions due to competing priorities or supply issues.”
Choosing a CDMO is a big-picture decision. “Depending on the scope of the project, the biotech should meet with multiple key stakeholders across the CDMO’s organization to determine if the CDMO has the infrastructure to support their project from R&D to scale up and manufacturing,” said Hickman.
The right balance between price and value
Cost is a central consideration when choosing a CDMO, but experts widely agree that focusing on price alone can lead to costly mistakes down the road. Several warned that a low initial quote may mask hidden risks related to quality, flexibility, or regulatory execution.
Shapiro summarized the lesson simply: “Over-indexing on cost is a bad idea. The cheapest quote can become the most expensive mistake if quality or execution falters.” From his perspective, true value comes from responsiveness, willingness to engage in problem-solving, and a genuine hunger from the CDMO to take on complex challenges, not just offering the lowest number on a spreadsheet.
Hay also emphasized that early-stage biotech companies must be cautious about how cost structures are set up. She explained that traditional fee-for-service models can sometimes misalign incentives, encouraging minimal effort rather than true collaboration. Shifting to a model that ties payments to key milestones such as accelerated timelines, successful batch releases, or regulatory approvals can create a much healthier dynamic. “Engaging the manufacturer to accelerate a program by aligning payment to milestones creates a relationship in which all parties are focused on a clear goal,” she noted.
In practice, this means biotech companies should not only scrutinize the upfront proposal but also ask deeper questions about how costs could evolve over time. Hay recommended evaluating a CDMO’s openness to change orders, milestone-based billing, and flexibility in development pricing — all signals that a partner is thinking long-term, rather than locking clients into rigid frameworks that may later derail progress.
Ultimately, a strategic CDMO partnership should deliver predictable costs, high-quality outputs, and the flexibility to adjust as challenges arise. Paying a little more upfront for the right collaboration often proves far less expensive than recovering from misaligned, inflexible, or low-quality service later on.
Navigating the evolving biotech CDMO landscape
The CDMO landscape is changing, influenced by the evolving needs of biotech companies. A notable trend is the growing preference among biotechs for partnering with smaller, more specialized CDMOs. These organizations often offer greater flexibility, personalized attention, and a deeper alignment with the unique challenges of early-stage development. In contrast, larger CDMOs may prioritize their more substantial clients, potentially leading to longer wait times and less tailored support for smaller biotechs.
“Specialization is a major trend. Over the last five to 10 years, the number of CDMOs entering the market has vastly increased, while biotech funding has become increasingly stringent. This has created a competitive environment where expertise in niche areas means leading a key portion of the market,” said Cameron.
Additionally, there’s a shift from transactional relationships to strategic partnerships. Biotech companies are increasingly seeking CDMOs that can provide not just manufacturing capabilities but also collaborative problem-solving, regulatory guidance, and adaptability to changing project scopes.
“Consolidation in the industry is ongoing, with partnerships enabling CDMOs to offer end-to-end services and broaden their expertise. CDMOs realize that they are not only seen as a production partner, but as a services partner,” noted Hay.
Digitalization is also playing a pivotal role in reshaping CDMO services. The integration of advanced analytics, automation, and real-time monitoring is enhancing efficiency, ensuring quality, and accelerating time-to-market for biotech products.
In this dynamic environment, biotech companies must carefully assess potential CDMO partners, considering not only technical capabilities and cost but also cultural fit, flexibility, and a shared vision for innovation and quality. Choosing the right CDMO is not just a logistical decision, it’s a strategic partnership that can significantly influence a biotech’s success trajectory.
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