5 Questions To Ask Your CDMO: #4 – What's Your Sweet Spot?

By Bernhard J. Paul, Ph.D., Principal Consultant, Carinth Consulting LLC

Part 4 of a five-part series

Virtually every biotech or pharmaceutical company relies on contract development and manufacturing organizations (CDMOs) for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner.

In this series we explore a number of questions that will help you during the selection process and enable you to choose the right partner for your project.

Changing Requirements

As drug candidates make their way through clinical trials toward commercialization, requirements change quite substantially. In early phase, it’s usually all about speed since chemistry, manufacturing, and control (CMC) activities are frequently on the critical path. Successful outsourcing at this stage requires an organization that is flexible, can handle last-minute changes, and understands that “fit for purpose” is the key requirement. In the early phase there is no time for things to be perfect; they have to be good enough. Processes are unoptimized and still poorly understood, and analytical methods are still being developed and do not have to be fully validated. Especially on first-time GMP campaigns, there are often a number of last-minute changes, and these campaigns frequently produce several deviations. Therefore, it’s important to work with a team that understands this and can work through these challenges in an expedient fashion.

This is in contrast to projects in  late phase going toward commercialization, where processes should be thoroughly understood and analytical methods fully validated, and manufacturing activities should provide consistent results without a significant number of deviations. At this stage, flexibility is less of a requirement than solid organizational processes and the ability to translate pilot-scale synthesis or formulations into commercial manufacturing routes.

Clearly early- and late-phase projects require different teams with unlike mindsets to be successful. The same organization (or company site) that was outstanding in delivering your early-phase material might struggle to serve as the commercial provider, even if appropriate scale-up equipment is in place. If you are working with a team that covers early- to late-stage projects, ask what procedures, training, and structures are in place to ensure your project receives the appropriate focus whatever stage it is in.

The “Sweet Spot”

Especially for early-phase projects, there are usually some additional dimensions worth exploring. While many companies (or company sites) have experience with early-phase work, it’s important to dig a bit deeper during your vendor selection due-diligence activities to understand what certain companies do best — their “sweet spot.”

Before we dive into this further, we should think about what we really mean by sweet spot. Most people have a sweet spot. In a business environment, it might be an activity where we are maximally effective because it sits within the overlap of interests, talents, and knowledge. Outside of business, a singer's sweet spot might be a part of their vocal range that they can reach most comfortably and where their voice sounds best.

Like people, most companies (or sites in the case of larger companies) tend to have a sweet spot. Even though a number of vendors specialize in early development, one can usually discover a sweet spot through site visits and conversations with the team. For example, some companies are really good at manufacturing material with minimal changes under very tight timelines. The same company might, however, be outside their sweet spot if process or analytical development is required — even if it is a limited amount, as is typical in the early phase. That doesn’t mean the company cannot provide that service, but it might be something that’s slightly outside their comfort zone. Similarly, some companies are very good at taking rudimentary process and analytical procedures and turning them into a suitable Phase 1 package, but they might find it more challenging to scale-up a provided process “as-is.”

Looking at this from another angle, there is a big difference between routinely doing something and doing it once. Ask your potential partner how much experience they have in the specific areas your project requires. Is it in their sweet spot?

Many of your potential partners will reassure you they are good at everything, and that might be true. However, there will still be an area where that company is most efficient, comfortable, and experienced, and ideally your project should be near the center of that sweet spot. Of course, sometimes it’s not feasible to find a company whose sweet spot covers all activities and needs required for the project. In that case, it is important to consider what is most critical. For example, is a particular technology competency critical to deliver a certain project? Or is it simply the ability to deliver as quickly as possible?

Of course, many non-technical aspects are important when it comes to a company’s sweet spot. Some outsourcing providers are excellent at communication, while others might provide equally good work but don’t have the same skills and infrastructure when it comes to updating customers on ongoing activities. Consider your preferred way of working (hands-on or hands-off) and select a company whose strengths align with your style and who can cater to your expectations.

Just as a golf ball will travel farther when it is hit within the club’s sweet spot, your outsourcing partnership will be more productive and efficient when you select a partner whose core strengths align with your project needs. Or, as Bubba Watson, multiple winner of the Masters, put it: “It’s about hitting the ball in the middle of the club face and hitting it hard.” Deceptively simple indeed!

Stay tuned for the final part of this series, where we’ll discuss the importance of understanding the crucial but also very complicated topic of institutional knowledge.  

About the Author:

Bernhard J. Paul, Ph.D., is the founder and principal consultant at Carinth Consulting LLC, a drug development consulting firm based in the Boston area. He has worked in biotech and for multiple CDMOs in the U.S. and Europe, and he uses his extensive experience to advise companies on all aspects of small molecule development and strategy. Dr. Paul is the author of 21 U.S. patents and multiple peer-reviewed articles. He holds a Ph.D. from the University of Florida and an undergraduate degree from the University of Graz, Austria. He can be contacted at bernhard.paul@carinthconsulting.com.