Aldevron Breakthrough Blog

Capacity versus Capability

February 22, 2023 / by Aldevron

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 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 our next post regarding capacity and capabilities, we’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.

ABOUT THE AUTHOR

Picture 1132767573, Picture Aldevron

Aldevron serves the biotechnology industry with custom production of nucleic acids and proteins. Thousands of clients use Aldevron-produced plasmids, RNA and gene editing enzymes for projects ranging from research grade to clinical trials to commercial applications. Aldevron specializes in cGMP manufacturing and is known for inventing the GMP-Source® quality system. Aldevron operates the largest cGMP plasmid DNA manufacturing facility in the world at company headquarters in Fargo, North Dakota, with additional facilities in Madison, Wisconsin.