AAPS PharmSci 360 2024: Big Data and Variation in Excipient Production

As part of its AAPS PharmSci 360 2024 coverage, Pharmaceutical Technology^® spoke with Pauline Janssen, global technical lead and product development manager at DFE Pharma, about her presentation at the conference, “Using Big Data Analysis to Better Characterize Excipient Variability,” delivered on Tuesday, Oct. 22, 2024.

Janssen said there is inevitable variation in all production processes, including excipient production, and big data sets can help—but especially when those analyzing the data are subject matter experts.

“We believe it's important to understand, what is the consistency? Which [data can] you look at [for] specific parameters, for example, inconsistency documents where you can see what is the typical variation that can be expected in a certain parameter?” Janssen said in the interview. “But a challenge when you want to evaluate multiple excipients, maybe multiple parameters, is actually all the potential interrelationships between those parameters. If you want to do a full evaluation of all these parameters and maybe perform a full design of experiments, you would require a huge amount of resources. And actually, this is also one of the key concepts in the QBD [quality by design] approach that allows [us] to identify what is the typical variation and what is the relevant variation in a large data set.”

Click the above video to watch the full interview.

AAPS PharmSci 360 was held from Oct. 20–23, 2024 in Salt Lake City, Utah. Find the rest of our coverage here.

Pauline Janssen can be contacted at Pauline.Janssen@dfepharma.com, and more information can be found on DFE Pharma's website.