Evaluating Capabilities

July 19, 2023 / by Todd Howren, Ph.D.

Dealing with a maturing industry

In my previous post regarding the differences between capacity and capability, I discussed the point that reasonably successful CDMOs have the capacity to manufacture biomolecules in a reproduceable manner and deliver according to a timeline. However, sometimes clients tend to focus on a near-term timeline when evaluating potential CDMO partners, relegating matters that dictate long-term clinical success to future consideration.

While capacity and timeline are critical, the comprehensive capabilities of your partner CDMO greatly affect the potential for clinical success. More than ever, biopharma is being aggressively pushed to accelerate its timelines to hit program milestones. This drive to move quickly is most likely driven by the rapid and successful deployment of COVID mRNA vaccines.

Indeed, the need for speed is ever clear in the mRNA therapeutics and vaccine market. Investors, seemingly awestruck by the emerging mRNA space, want to capitalize sooner rather than later, while biopharma seems to be almost frenetic in its zeal to be first to market.

Capabilities and the product journey
When selecting a CDMO partner, what are the necessary priorities? Is it timeline, or partnering with a CDMO with the capabilities to address late-phase and commercialization requirements? Just remember, this does not have to be an either/or decision.

However, it does require an upfront evaluation and understanding of a CDMO’s capabilities, not only considering capacity and timeline, but also weighing what’s offered beyond the manufacturing process. Long-term clinical success will be either augmented or limited by what’s available outside of the GMP suite. These potential services are likely many and should be fully considered. Some of the capabilities to look at include, but aren’t limited to:

• Process design
• Analytical method development
• Analytical testing
• Process characterization
• PSQ experience and support
• CMC experience and support
• IND and regulatory support

But don’t forget the in-suite options
Clients often select a CDMO partner based solely on the timeline to a Phase I batch. But capabilities within the suite are also critical, specifically the capability to scale as a program progresses from preclinical-to-clinical-to-commercialization.

While time to Phase I is important and must be considered, there are many instances where a CDMO does not possess the experience or capabilities to address late-phase and commercialization requirements and needs. A short-sighted decision solely focusing on Phase I could ultimately delay the overall program. The late-phase and commercialization phases would likely require a tech transfer to a second CDMO, potentially extending timelines and increasing costs. That scenario was addressed in an earlier post by my colleague, Larry Lockwood.

Once you have done your due diligence and found a process and scale representative of what you need to have done in GMP, you should be able to move your project ahead and be able to manufacture clinical grade material at the required scale without adding unnecessary steps to the process.

• Want to learn more? Contact Todd Howren with questions on this topic
• Preparing to do an mRNA production run? Read Todd’s post on readiness
• Visit the mRNA page of our website
• Watch Todd's presentation, Building a Comprehensive mRNA Production Ecosystem
• Have a topic to suggest? Let us know