Take It from the Top

February 5, 2025 by Emma Bjorgum

Planning the path to your destination

It all starts here. The beginning of the line. The beginning of the supply chain. In cell and gene therapy, supply chain planning and management is one of the most crucial aspects that can make or break success.

We know that plasmid DNA is often the first in a domino-like series of critical materials that need to be ready at just the right time so that when the dominos start to fall, they cascade elegantly, tipping into place piece by piece.

Although perhaps not as visually pleasing as a cascade of dominoes, the cell and gene therapy supply chain does require alignment of many important pieces in a specific order. To deliver therapeutics to patients in a given timeline, an organization must consider:

• When will I plan to dose patients?
• When will I need to produce viral vector?
• When will I need to produce plasmid DNA?

To address these questions, it is tempting to ask your CDMO partner, “What is the turnaround time?” or, “How long will it take?” No doubt, turnaround time is important. Since being acquired by Danaher in mid-2021, Aldevron has been employing the Danaher Business System, a renowned continuous improvement methodology, to reduce turnaround time. In 2023, alone, we achieved a nearly 40% reduction, on average, for cGMP plasmid manufacturing from start of manufacturing in suite to quality release of plasmid DNA.

We are proud of our continuous improvement results, but we are now striving to change the conversation from “How long will it take?” to the more critical question, “When do you need it?”

This way of thinking allows the supply chain needs to be planned with the end (the patient) in mind. As an example, if you plan to dose patients in 12 months, and you need vector in 9 months, and then you need plasmid in 6 months, you can start to line up your dominos with mentality of “I need this material to be available by this date.”

While this may seem like a simple concept, shifting from “turnaround time” to a “delivery date” is truly a paradigm shift in planning and execution. This allows the dominos to be lined up such that the delivery of the therapeutic to the patient initiates the entire cascade.

The next time you are planning for success in your clinical trial, begin with the end in mind. Place each domino in your supply chain carefully one right after the other by first asking, “When do I need this?”

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