The Challenge of Raw Material Variation in Adopting Continuous Manufacturing (AAPS PharmSci 360)

In an exclusive interview with BioPharm International® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, discusses one of the major challenges in the adoption of continuous manufacturing: variation in raw materials.

There is variation in raw materials, including both excipients and active pharmaceutical ingredients. Variations can include particle size, white density, etc., and these variations may impact the quality of the final product, Fathollahi states.

“This is very important to consider, and the manufacturers that want to enjoy the benefits of continuous manufacturing, such as faster production, more efficient production, and lower cost, [should] plan to overcome this challenge,” says Fathollahi.

Typically, manufacturers manage this challenge by, first of all, selecting a reliable raw material supplier to ensure consistent delivery of raw material with high quality. “[Manufacturers] work closely with excipient suppliers to understand the variation in their raw materials that they receive from them, and also, in line with what is designed for continuous manufacturing, they assist this variation in what it means for their process and what is the impact on the final product,” she says.

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 redesign concepts for continuous manufacturing and excipient suppliers supporting continuous manufacturing adoption.