Aldevron Breakthrough Blog

Capacity versus Capability

February 22, 2023 / by Todd Howren, Ph.D.

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:

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:

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:

  • Master cell banks
  • Supercoiled plasmid DNA manufacturing
  • Linearized plasmid DNA manufacturing
  • VT mRNA manufacturing
  • LNP formulation and encapsulation
  • Complete fill/finish process
  • Analytical testing for mRNA drug substance and drug product
  • Process and method development
  • Regulatory support

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.


Todd Howren, Ph.D.

Todd Howren, Ph.D.

Todd Howren, Ph.D., is Aldevron’s Vice President, RNA, with more than 25 years of experience in the life sciences industry, including 10 years in business development leadership. Howren earned a Bachelor of Science in Biology from Baylor University, Waco, Texas, and his Ph.D. in Physiology and Biophysics from the University of Arkansas for Medical Sciences, Little Rock, Arkansas. He has published several scientific papers and has presented at multiple conferences and symposiums. Howren previously served as Vice President, Global Commercial Operations, Life Sciences Division at Meridian Bioscience. He also spent nearly 15 years at Thermo Fisher Scientific, ending as lead for global business development in human molecular diagnostics and mRNA. He joined Aldevron in 2020 as Vice President of Sales.