What do they mean for you?
Capacity: The total amount that can be contained or produced
Capability: The ability to do something
*As defined by the Cambridge Dictionary
One of the issues I’ve heard raised in our industry is about how we define capacity and capability. As you can see from the definitions above, these are two very different items. But what do these two terms mean with respect to the manufacture of mRNA drug substance and/or drug product?
Breaking it down
When thinking about capacity the most common questions are:
- What is the maximum yield per batch (or IVT reaction size)?
- Are manufacturing suites readily available or can I reserve a spot in the schedule?
- What is the time in suite, or how fast can you turn?
These are important considerations. However, for any CDMO, capacity (as defined above) is merely a chip in the game. Simply having capacity doesn’t mean that the CDMO has the ability to successfully manufacture, test, and release mRNA drug substance or drug product at scale, and on time.
It could be argued that the most rigor should be devoted to capability versus capacity. Experienced and proven capability is paramount for clinical success. A couple preliminary questions to consider are:
- Does the manufacturer have in-house analytical capabilities or are the majority of tests being outsourced?
- Does the CDMO have a robust process development and analytical development department?
Once you answer these questions, you will have a better idea if the fundamental elements critical to long term success are in place.
How to choose
Identifying a CDMO having a proven and capable RNA ecosystem is critical. This will enable you to manage a program from end-to-end with a single partner having all the required capabilities under one roof and quality system. This means your CDMO must have capacity and capabilities addressing:
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In my next post regarding capacity and capabilities, I’ll talk about the value a customer can get by finding a partner with all those capabilities under one roof, along with the capacity to meet needed production levels.
