A Look at How Excipient Suppliers Can Support Adoption of Continuous Manufacturing (AAPS PharmSci 360)

In an exclusive interview with BioPharm International® at AAPS PharmSci 360, Sara Fathollahi, PhD, product application specialist, DFE Pharma, gives a summary of the takeaway message from her presentation at the conference.

“My main point … was [about] how excipient suppliers (taking DFE Pharma as an example) can support a smooth transition from batch to continuous manufacturing. I believe that the pharma industry is like a big complex puzzle. Each of us—excipient suppliers, manufacturers, machinery suppliers, universities, research centers—we are pieces of this puzzle, and we are individual pieces, but, together, we make the big, impressive image of innovation,” Fathollahi explains.

In her talk, Fathollahi showed how her company supports its customers by using excipients to de-risk the manufacturing process. “What we do is that we share [internal] … data. We have historical data of all batches that we produce and that support us [in showing] which variation the customer can expect from our material. Then, we can also select batches for them, and with [those] batches—in addition to experiments that they do on their end—they can prove robustness to the regulatory bodies,” she states.

“To give you a more specific example, let's say that the manufacturer received one, five, or ten batches from us; even though, after conducting really complete characteristics on the batches they received from us, thedata that they have [are] limited to those batches. As a supplier, we have historical data, we can really provide much more information and can give insight about which variation can be expected from our product in the next five years, for example,” Fathollahi emphasizes. In addition, DFE Pharma can also select batches that are representative of the variation that can be expected from a specific product, and those batches can be tested by customers.

“This is the way that we … support a smooth transition from batch to continuous manufacturing—by addressing the challenge of raw material variability,” Fathollahi adds.

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 raw material variation.