The last two decades have been busy in the contract development and manufacturing organization (CDMO) industry. From established pharmaceutical giants to therapeutics start-ups, companies of all sizes increasingly view CDMOs as essential to their drug development strategy. This surge in demand has led to a rise in mergers and acquisitions as CDMOs vye to expand their service offerings and attract new business. As a result, the CDMO industry as a whole is expected to grow from $148.5 billion in 2019 to reach $224.9 billion by 2025. 

Learning to navigate this highly competitive market is a real test of skill (and potentially luck) for drug developers. This is especially true for those in the early, preclinical research phase, who don’t necessarily have extensive experience negotiating the technical and regulatory complexity of a successful process development and scale-up program.

If you fall into that category, here are five qualities to look for in a CDMO partner. Following this guide will ensure that your partner has both the knowledge and the internal quality systems that you need to move your product to market smoothly, quickly and cost-effectively.

1. Your CDMO adapts to fit your needs—not the other way around
The challenge: Remember the early days of cable TV? To get the channel you wanted, you’d have to buy the whole package. That’s how sports fans wound up paying for kids’ programming they never watched, or movie buffs found themselves lost in a brine of daytime talk shows. It simply wasn’t possible to un-bundle the bundle.

In some ways, large, mainstream CDMOs are similar. Clients must fit into a standardized agreement, often committing to a broad suite of services in order to get what they need at that particular moment. For small-scale developers who are singularly focused on the next most important milestone, whether that’s evaluating salt forms of potential APIs or pursuing IND approval to unlock more funding, this “one size fits all” approach can compromise future flexibility and impact speed-to-market.

The solution: Look for a partner who doesn’t ask you to conform to a template. Typically, this means finding a flexible, service-oriented CDMO that’s willing to right-size their offering according to your brief.

This doesn’t mean that they’re narrowly focused on your current situation to the exclusion of your future needs; instead, the right partner will help you to move confidently from A to B while also thinking ahead to C, D, and F. If you’ll face a long lead time to get the small quantity of APIs necessary for your eventual clinical research, for example, the right CDMO will see that potential bottleneck coming, and will set the right steps in motion to remove it. In the meantime, they’ll portion out the services you need as you need them, leaving room to adapt and evolve your approach as the project matures.

2. Knowledge transfer happens smoothly, enabling progress despite supply chain complexity
The challenge: Convulsions in the global pharmaceutical supply chain are making progress difficult for many drug developers. To succeed, they must contend with overburdened manufacturers, a worldwide shortage of plastics and other consumables, prolonged border closures, a sharp decline in sea and air transportation coupled with increased shipping costs, and many more logistical complexities.

Many developers are trying to navigate these challenges on their own, or with a string of standalone partners: one to help supply their hard-to-find API, another to help them develop and analyze their formulation, a third to oversee their regulatory filing. As a result, they’re spreading their time between too many partners, trying to reconcile incompatible schedules while struggling to get the right information to the right team at the right time. Under these circumstances, it’s all but inevitable that communication will break down and critical deadlines will fly by, unmet. 

The solution: The fewer independent teams you’re juggling, the fewer setbacks you’ll face.

Many CDMOs market themselves as an all-in-one, “discovery to clinic” resource, but there’s a difference between clustering standalone services under a corporate banner and truly integrating those services for an optimized experience. To put it simply, the best CDMOs spend time developing strong partnerships from within in order to strengthen their partnerships with clients.

As a result, all of their expert teams, from the API procurement team to R&D to regulatory submissions, work in flow together. They’re able to meet your manufacturing deadlines despite unpredictability in the supply chain because they operate from a single, unified understanding of your project and its goals, and they use that shared understanding to make fast and flexible decisions as circumstances change.

3. You have a partner, not an order-taker
The challenge: New drug developers may not recognize the early warning signs of a wrong turn. You could be paying more than you need to for your API, or spending longer than necessary on your research, or committing to an unscalable process. Unless you work with a partner who takes the time to communicate with you upfront about these risks and how to avoid them, you may not see them until too late.

Communication on that level is not a given, though. In some CDMO/client relationships—especially relationships in which the CDMO is very large, and the client is small—bureaucracy can snarl the flow of dialogue, impairing the project’s forward momentum. It’s hard to reach the right people with your questions, or get answers when you need them. Every day that an email sits unanswered or a call unreturned is a day added to the project’s timeline. 

The solution: Pay close attention to your CDMO’s approach as they bring you on board. Are they committed to understanding your objectives? Are they transparent about the quality systems built into their process, and how those systems will help you meet your specific needs? When you ask a question, does the answer come promptly from the people directly involved in your project?

What you’re looking for is a partner who’s willing to challenge you in meaningful ways—a partner who’s actively engaged in finding the most quality-driven and cost-effective path forward, even if that path doesn’t look the way you expected it to at the outset.

This goes beyond your onboarding conversations, of course. From start to finish, a good partner will encourage an ongoing dialogue about the quality, pace and cost considerations of your project. They will focus on developing a robust and scalable approach that will work for the entire lifecycle of your program, which requires them to weigh the risks and opportunities at every new phase in your development. In other words, this isn’t about a “one and done” conversation—it’s about a continuous exchange of knowledge, and a shared commitment to the end result. 

4. Your submission is ready when you are
The challenge: Regulatory agencies in the U.S. and abroad are moving fast to keep up with the innovations and emerging science of new pharmaceutical discoveries and technologies. Nothing is constant; what was true from the perspective of regulatory approval a year ago may no longer be true today.

For drug developers to hit this moving target, they need to prepare submission documents that give regulators confidence in both their API and their final drug product. Many entrust their CDMO with this responsibility, who in turn might engage a third-party submissions team or operate a separate regulatory department within their organization. The key word here is “separate”: the silo that separates the submissions team from the front-line development team can be a liability. It means that your project depends on a traditional relay-based workflow, in which standalone teams hand off tasks and critical information like a baton. This can dilute any sense of collective ownership, resulting in submission documents that might meet minimum requirements—but minimum requirements, in such a fast-changing and high-stakes world, are often not enough.

The solution: Work with a CDMO whose regulatory submissions team operates hand-in-hand with all other teams, from the R&D and formulations group to ancillary support services like analytics and stability testing.
This deep integration indicates a commitment to Quality by Design (QbD), a principle that encourages rapid regulatory approval by way of data-driven, science-based risk management from project initiation all the way through commercial process validation.

In a CDMO that practices QbD, teams work closely together to measure, analyze and report on the quality attributes of your product. The experts who develop your upstream regulatory strategy and initial CMC plan are also writing your final filing. They have a front-line understanding of your project and how best to represent it to regulators—which can be a complex undertaking, given that the FDA’s hot-button issues may change every few years. Your integrated submissions specialists will stay up-to-date on those issues in order to encourage a fast and problem-free approval process.

5. You’re a priority for regulators
The challenge: With COVID-related projects absorbing a large share of regulatory attention, drug developers face the prospect of a prohibitively long wait for approval.

The solution: It goes without saying that you should look for a CDMO in good standing with the FDA, with a history of successful inspections and no major Form 483 observations on their record. Not only does this indicate a good-quality manufacturing operation, but it also suggests that this is a CDMO with valuable regulatory experience.

That experience could help you enormously as you and your CDMO partner initiate a controlled correspondence with regulators, starting with a timely pre-IND meeting. This initiative opens the channels of communication between you, your CDMO, and the regulatory team who will review your submission, helping project developers to plan and optimize your upstream regulatory strategy so that your submission stays top-of-mind and relevant, even in this turbulent regulatory climate.

A final word
When you’re new to the drug development process and looking for a CDMO to help you through it, you might feel a sense of “safety in size.” The bigger the CDMO, the more certain your success, right? The trouble is, many of the large players grew from the outside in, acquiring capabilities without necessarily integrating them in a way that helps to ease communication, accelerate results, and deliver a high-quality, submission-ready regulatory filing.

The takeaway: instead of scoring a potential CDMO based on their size, look at their internal systems for a true indication of their fit as a partner. They should be experienced and agile, to help you navigate unforeseen challenges; open and transparent, to help you mitigate risks and control your costs; and as committed to your success as you are. These are the ingredients of a resilient and long-lasting partnership, and the indicators of future success.