Making the Right Amount
Determining the amount of plasmid to manufacture for a clinical trial is foundational to defining both a realistic budget and project time line. Because it typically takes six to eight months to manufacture a batch of plasmid under GMP, you can’t afford to underestimate how much plasmid to make. Getting it wrong can increase your manufacturing costs and delay your study.
Start With the Trial
So how do you determine how much plasmid to make? The obvious first step is to calculate how much product is needed for your trial by multiplying the dose by the number of doses administered. Don’t forget to add in a little extra volume into each vial (typically 0.2 ml) so a syringe is able to retrieve the full injection amount.
After determining the amount of plasmid you need for your trial, the next step is to determine how much plasmid is required to meet various QA and QC requirements such as:
- In-process testing
- Final release testing
- QC retains
- Stability retains
- Stability studies
This additional amount can add up quickly. In fact, you might have to produce twice as much plasmid as you think you need to cover your trial and QA!
There is one more thing to consider. Because GMP plasmid manufacturing is primarily a fixed cost activity, the cost of manufacturing does not increase proportionally with the amount of plasmid produced. Therefore, it makes sense to manufacture as much plasmid you can afford the first time. That way you don’t have to start over if there is a problem with your trial or, if you need to make changes such as adding another study arm.
Free White Paper
We published a FREE white paper that shows you how to calculate the amount of plasmid to manufacture for a clinical trial taking into account all the various QA requirements. Click here to download your copy now!