Redesign Concepts Critical for Continuous Manufacturing (AAPS PharmSci 360)

In an exclusive interview with BioPharm International® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, points out certain redesign concepts that are critical for switching from batch manufacturing to continuous manufacturing.

One key critical concept involves quality by design (QbD), in which a systematic approach is used in pharmaceutical development that focuses on designing quality into the product from the beginning, she says. “It includes defining critical quality attributes, identifying critical material attributes, [and] critical process parameters using their risk assessment and experimentation to understand and control manufacturing processes,” Fathollahi emphasizes.

Fathollahi goes on to explain that one big benefit of the QbD approach is that it helps manufacturers to better understand the correlation between raw materials, the process, and the quality of the final drug product. “This is important, as it supports robust and consistent production in a continuous manufacturing environment,” she explains.

“Embracing quality by design supports manufacturers in designing processes [such] that they are able to compensate variation seen in raw materials without compromising on quality, stability, and functionality of the final drug product,” Fathollahi concludes.

Fathollahi was featured as a speaker at AAPS PharmSci 360 where she gave her talk, “Impact of Raw Materials Variation On Continuous Feeders Performance.” Her presentation centered around gaining a better understanding of the natural batch-to-batch variability of raw materials; understanding the link between raw material variation and the manufacturing process; understanding which variation is present in a given raw material and what that specific variation means for the manufacturing process; assessing the risk of using raw materials (with their natural variation) on process robustness and consistency of the final product; and understanding how to derisk the use of excipients in continuous manufacturing processes.

AAPS PharmSci 360 ran Oct. 22–25 in Orlando, Fl.

View Fathollahi’s video interviews on raw material variability and excipient suppliers supporting continuous manufacturing adoption.