Building an mRNA Ecosystem

September 21, 2022 / by Aldevron

Capacity is only part of the solution

During conferences and seminars this year, there has been one particular topic that has come to the fore regarding mRNA production – capacity. Most of the concern comes from the impression that there isn’t enough capacity to meet market demand.

However, I feel it is very important to put those comments and concerns into context, understanding the root cause leading to extended timelines. Indeed, most extended timelines are not related to capacity constraints, but rather are related to a program’s readiness to initiate an engineering or GMP batch.

Readiness is the key component
For many programs, it is not uncommon to take six months to achieve readiness for an mRNA production run, as fundamental questions often have not been addressed or considered, regardless of the manufacturing partner.

What are those fundamental readiness questions and activities? As my Aldevron colleagues Venkata Indurthi, Chief Scientific Officer, and Nate Spangler, Senior Director Innovation and Strategy, would say —these questions need to be asked and answered before proceeding with a project, including:

• Is the template design from promoter to poly(A) tail finalized?
• Whose process will be used for GMP scale-up: the CDMO’s, the partner's, or a process developed by the CDMO for the partner?
• If doing a tech transfer to the CDMO, how ready is the partner's process for GMP scale up?
• What assays are needed for in-process testing and drug-product release, and have release specifications been set?
• How soon is GMP material needed?

After making sure that those questions are answered and the readiness activities completed, or in the process of being completed, that’s where timeline development, suite availability and capacity come into play. Essentially, for any client who wants to move fast, that speed is determined by how quickly readiness activities can be completed.

Working to meet demand
To use Aldevron as an example, we are adding an additional mRNA suite in Q1 of 2023 to expand our capacity in response to demand. To fully utilize that capacity, however, means making sure those who need mRNA production can answer the questions outlined above. That will help ensure timelines are met and staff is ready to meet the client’s needs.

Answering readiness questions has become even more important now as the industry itself is learning more and more about unmet patient needs, health care needs and gaps in the development process that we need to be able to fill. To do that, we need to go beyond just building mRNA production capacity. We are building a full development ecosystem with one quality system from start to finish that can operate as a unified service, providing greater value to the market, and meeting those patient needs.

• Want to learn more? Contact Todd Howren with your questions
• Visit the mRNA section of our website
• Have an idea for a topic? Let us know!